Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT04165135
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D005169', 'term': 'Factor VIII'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821 8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'No adverse event data were collected during this study.', 'description': 'As pre-specified in the protocol for this non-interventional study, no adverse event data were actively collected during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Daily Active Minutes of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care:31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Heart Zone Minutes', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000', 'lowerLimit': '-45.2', 'upperLimit': '151.6'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '38.3'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '13.9', 'upperLimit': '64.6'}]}]}, {'title': 'Active Zone Minutes', 'categories': [{'measurements': [{'value': '226.5', 'groupId': 'OG000', 'lowerLimit': '173.8', 'upperLimit': '279.2'}, {'value': '309.4', 'groupId': 'OG001', 'lowerLimit': '264.6', 'upperLimit': '354.1'}, {'value': '284.1', 'groupId': 'OG002', 'lowerLimit': '246.3', 'upperLimit': '321.9'}]}]}, {'title': 'MVPA Minutes', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '27.2'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '61.0'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '14.2', 'upperLimit': '43.0'}]}]}], 'analyses': [{'pValue': '0.7630', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Heart zone minutes: Comparison among the age groups was performed by means of a Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0913', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Active zone minutes: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0956', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'MVPA minutes: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Physical activity data was collected as daily active minutes measured on each valid day by wearing a fitness tracker continuously during study participation. Valid day = a day in which fitness tracker was worn for at least 10 hours. Daily active minutes were saved in two different sets of data collected by fitness tracker. For each set minutes were categorized by intensity of activity done. First set = minutes categorized according to time collected in each heart zone. Overall heart zone minutes = fat-burn minutes (heart rate: 50-69% of maximum) + cardio minutes (medium-to-high intensity exercise zone corresponds to heart rate: 70-84% of maximum) + peak minutes (high-intensity exercise zone, corresponds to heart rate \\> 85% of maximum). Second set =minutes categorized according to active zones. Overall active zone minutes=lightly active minutes +fairly active minutes+very active minutes. Moderate-to-Vigorous Physical Activity (MVPA) minutes=Fairly active minutes+Very active minutes.', 'unitOfMeasure': 'number of daily active minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'PRIMARY', 'title': 'Mean Number of Steps Taken Per Day by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31- 50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '5402.4', 'groupId': 'OG000', 'lowerLimit': '3150.3', 'upperLimit': '7654.5'}, {'value': '8788.3', 'groupId': 'OG001', 'lowerLimit': '7233.9', 'upperLimit': '10342.7'}, {'value': '8279.8', 'groupId': 'OG002', 'lowerLimit': '6419.9', 'upperLimit': '10139.7'}]}]}], 'analyses': [{'pValue': '0.0649', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Number of steps taken by the participants on each valid day were measured by wearing a fitness tracker continuously during study participation. Valid day was defined as a day in which fitness tracker was worn for at least 10 hours.', 'unitOfMeasure': 'number of steps per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'PRIMARY', 'title': 'Mean Metabolic Equivalent of Tasks (METs) Per Day Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31- 50 Years', 'description': "Participants who were 31- 50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '6.5'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '5.5'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '4.9'}]}]}], 'analyses': [{'pValue': '0.0026', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The MET is an objective measure of the ratio of the rate at which a person expends energy, relative to the mass of that person, while performing some specific physical activity compared to a reference. The METs were derived as: (amount of kilo calories (kcal) collected in the fat-burn, cardio, and peak minutes) / \\[(sum of fat-burn, cardio and peak hours) \\* weight of the participant in kilograms (kg)\\].', 'unitOfMeasure': 'MET per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Mean Rate of the Number of Times Engaging in Physical Activity Per Week by Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.10'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.26'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '-0.01', 'upperLimit': '0.37'}]}]}, {'title': 'Swimming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.06'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.12'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Tapis Roulant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.07'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.23'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.08'}]}]}, {'title': 'Gym Weights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.06'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '-1.93', 'upperLimit': '3.20'}, {'value': '0.13', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.23'}]}]}, {'title': 'Exercises at Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '1.24'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '1.28'}, {'value': '0.51', 'groupId': 'OG002', 'lowerLimit': '0.34', 'upperLimit': '0.68'}]}]}, {'title': 'Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '1.01'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.63'}, {'value': '0.88', 'groupId': 'OG002', 'lowerLimit': '0.44', 'upperLimit': '1.33'}]}]}], 'analyses': [{'pValue': '0.9493', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Running: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8305', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Swimming: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8725', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3380', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9706', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1727', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'General: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0099', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Walk: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The activity weekly rate was derived on a per participant basis as ratio between the number of times that the type of activity is reported on the fitness tracker (numerator) and the length of the observational period (i.e. end of study date - baseline date + 1) (denominator) and then multiplied by 7. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.', 'unitOfMeasure': 'number of times per week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Active Minutes by Intensity (Lightly Active Minutes) for Each Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care:31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.6'}]}]}, {'title': 'Swimming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '12.1'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '5.0'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '7.1'}]}]}, {'title': 'Tapis Roulant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '6.9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '3.9'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '-7.4', 'upperLimit': '17.4'}]}]}, {'title': 'Gym Weights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '2.6'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '17.3'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '5.7'}]}]}, {'title': 'Exercises at Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '2.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '6.2'}]}]}, {'title': 'General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '19.3'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '7.3'}, {'value': '5.8', 'groupId': 'OG002', 'lowerLimit': '3.4', 'upperLimit': '8.2'}]}]}, {'title': 'Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.4'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '4.4'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '6.7'}]}]}], 'analyses': [{'pValue': '0.6151', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Running: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9332', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Swimming: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4726', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4111', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0892', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1642', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'General: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7256', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Walk: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The number of active minutes by intensity (lightly, fairly, and very active minutes) were obtained at the participant level on a per activity basis as the median of the values collected by the fitness tracker for each activity recorded during the observational period. In this analysis, the means and 95% confidence intervals were calculated using the median lightly active minutes by type of physical activity performed by participants with available data. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.', 'unitOfMeasure': 'lightly active minutes per activity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Active Minutes by Intensity (Fairly Active Minutes) for Each Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care:31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.0'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.6'}]}]}, {'title': 'Swimming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '8.8'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '10.1'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Tapis Roulant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.1'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '-2.2', 'upperLimit': '5.2'}]}]}, {'title': 'Gym Weights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.9'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '-21.3', 'upperLimit': '38.0'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '17.3'}]}]}, {'title': 'Exercises at Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '5.2'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '21.6'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '14.2'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '11.8'}]}]}, {'title': 'Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '18.3'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '11.8'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.0745', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Running: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2177', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Swimming: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2121', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2336', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Gym weights: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4190', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Exercises at intervals: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0252', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'General: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2143', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Walk: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The number of active minutes by intensity (lightly, fairly, and very active minutes) were obtained at the participant level on a per activity basis as the median of the values collected by the fitness tracker for each activity recorded during the observational period. In this analysis, the means and 95% confidence intervals were calculated using the median fairly active minutes by type of physical activity performed by participants with available data. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.', 'unitOfMeasure': 'fairly active minutes per activity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Active Minutes by Intensity (MVPA Minutes) for Each Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '12.9'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '51.8'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '25.7'}]}]}, {'title': 'Swimming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '-7.7', 'upperLimit': '12.4'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '24.4'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '13.6'}]}]}, {'title': 'Tapis Roulant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '37.1'}, {'value': '17.5', 'groupId': 'OG002', 'lowerLimit': '-34.2', 'upperLimit': '69.2'}]}]}, {'title': 'Gym weights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '-16.5', 'upperLimit': '26.5'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '-56.8', 'upperLimit': '155.5'}, {'value': '29.6', 'groupId': 'OG002', 'lowerLimit': '-9.8', 'upperLimit': '69.0'}]}]}, {'title': 'Exercise at Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '12.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '56.3'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '45.4'}, {'value': '26.5', 'groupId': 'OG002', 'lowerLimit': '14.3', 'upperLimit': '38.6'}]}]}, {'title': 'Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '33.0'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '28.1', 'upperLimit': '39.2'}, {'value': '30.3', 'groupId': 'OG002', 'lowerLimit': '20.7', 'upperLimit': '39.8'}]}]}], 'analyses': [{'pValue': '0.0085', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Running: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1098', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Swimming: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2703', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3366', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0992', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1194', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'General: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0549', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Walk: Comparison among age groups was performed using Kruskal-Wallis test.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The number of active minutes by intensity (lightly, fairly, and very active minutes) were obtained at the participant level on a per activity basis as the median of the values collected by the fitness tracker for each activity recorded during the observational period. The MVPA minutes is the sum of fairly active and very active minutes. In this analysis, the means and 95% confidence intervals were calculated using the median MVPA minutes by type of physical activity performed by participants with available data. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.', 'unitOfMeasure': 'MVPA minutes per activity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Adherent to World Health Organization (WHO) Global Recommendations on Physical Activity for Health Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Yes (Active Subjects)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '42.3', 'groupId': 'OG002'}]}]}, {'title': 'No (Sedentary Subjects)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '31.8', 'groupId': 'OG001'}, {'value': '57.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0088', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Comparison among age groups was performed using Chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'A participant was defined "adherent" to WHO guidelines according to the following algorithm: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). A participant who was adherent to the WHO guidelines according to the above definition was defined as an "active participant", otherwise as a "sedentary participant".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by the Presence of Bleeds (0 vs. ≥1 Bleeds) Over the Course of the Study, Reported Via the ePRO Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care:18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31-50 Years', 'description': "Participants who were 31- 50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'Bleeds that occurred the same day but in different body site were counted separately.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by the Presence of Bleeds (0 vs. ≥1 Bleeds) Over the Course of the Study According to the Different Types of Bleeds (Spontaneous, Traumatic and Procedure/Surgery Related), Reported Via the ePRO Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31-50 Years', 'description': "Participants who were 31- 50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Spontaneous Bleed', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Traumatic Bleed', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Bleeds Related to Procedures/Surgeries', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months).', 'description': 'The assessment of bleeds was divided into spontaneous bleeds, traumatic bleeds, and bleeds related to procedure/surgery. Spontaneous bleeds = the occurrence of hemorrhage where neither the participant nor a caregiver could identify a reason. Traumatic bleeds = hemorrhage occurring secondary to an event such as trauma, "strenuous" activity, or "overuse". Bleeds related to procedure/surgery = such as hematomas resulting from any surgeries or invasive procedures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by the Presence of Bleeds (0 vs. ≥1 Bleeds) Over the Course of the Study According to the Bleed Sites (Urine, Feces, and Vomit, Joint, Muscle, and Other Bleeds), Reported Via the ePRO Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: 12-17 Years', 'description': "Participants who were 12-17 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Standard of Care: 18-30 Years', 'description': "Participants who were 18-30 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG002', 'title': 'Standard of Care: 31-50 Years', 'description': "Participants who were 31-50 years of age with severe or moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Urine, Faeces, and Vomit Bleeds', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Joint Bleeds', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Muscle Bleeds', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Other Bleeds', 'categories': [{'title': '0 Bleeds', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}, {'title': '1 or More Bleeds', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and whenever bleeding occured from study initiation to completion (up to 18 months)', 'description': 'Sites of bleeds were defined as urine, faeces, and vomit (three sites grouped together), joint, muscle, and other bleeds.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by the Type of Regimen Used for Treatment of Haemophilia A Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Prophylaxis For Haemophilia', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'On Demand for Haemophilia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The following types of regimens used to treat haemophilia A are reported here: on-demand (to stop bleeding) and prophylaxis (regular infusions of clotting factor to prevent bleeds). Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by the Product Used for Treatment of Haemophilia A Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Prophylaxis for Haemophilia: Octocog Alfa', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Efmoroctocog alfa', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Moroctocog Alfa', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Turoctocog Alfa', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Lonoctocog Alfa', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Rurioctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Damoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Simoctocog Alfa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Turoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Factor VIII (Antihaemophilic Factor)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Factor VIII, Recombinant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Emicizumab', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Desmopressin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis for Haemophilia: Tranexamic Acid', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'On Demand for Haemophilia: Octocog Alfa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Switched to a New Approved Drug for Treatment of Haemophilia A by the Product Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Turoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Damoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Rurioctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Emicizumab', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to the time of switch to a new therapy (up to 18 months)', 'description': 'Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Treated Bleeds Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Bleeds', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'An event was considered a treated bleed if coagulation factors were administered to treat signs or symptoms of bleeding (e.g., pain, swelling, etc.).', 'unitOfMeasure': 'number of treated bleeds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bleeds', 'denomUnitsSelected': 'Bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of bleeds analyzed=number of bleeds during analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Bleeds Treated With Each Type of Treatment for Bleeding (Haemostatic Treatment, Treatment for Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Treated bleeds', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Haemostatic Treatment', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Treatment for Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to whenever bleeding occurred (up to 18 months)', 'description': 'An event was considered a treated bleed if coagulation factors were administered to treat signs or symptoms of bleeding (e.g., pain, swelling, etc.).', 'unitOfMeasure': 'number of treated bleeds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated bleeds', 'denomUnitsSelected': 'Treated bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of bleeds analyzed=number of bleeds during analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment for Bleeding Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Treated bleeds', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated bleeds', 'denomUnitsSelected': 'Treated bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Bleeds Treated With Each Route of Administration Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Treated bleeds', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Intravenous', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Subcutaneous', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Intramuscular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Nasal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ophthalmic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Oral', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Rectal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'Number of bleeds treated by intravenous, subcutaneous, intramuscular, nasal, ophthalmic, oral, rectal, and other routes of administration are reported here.', 'unitOfMeasure': 'number of treated bleeds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treated bleeds', 'denomUnitsSelected': 'Treated bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of bleeds analyzed=number of bleeds during analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Bleeds Which Needed to Receive a Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Bleeds', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'unitOfMeasure': 'number of bleeds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bleeds', 'denomUnitsSelected': 'Bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of bleeds analyzed=number of bleeds during analysis at given timepoint'}, {'type': 'SECONDARY', 'title': 'Number of Bleeds Which Needed to Administer an Additional Hemostatic Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Bleeds', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'unitOfMeasure': 'number of bleeds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bleeds', 'denomUnitsSelected': 'Bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of bleeds analyzed=number of bleeds during analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Bleeds With Adherence to Treatment Regimen for Haemophilia A in the Week Preceding the Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}, {'units': 'Bleeds', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'The adherence to the treatment regimen for haemophilia A was analyzed as the number of bleeds with an answer equal to "Yes" and "My therapeutic plan does not include any treatment in the last week" in the week preceding the bleeding.', 'unitOfMeasure': 'Number of bleeds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bleeds', 'denomUnitsSelected': 'Bleeds', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of bleeds analyzed=number of bleeds during analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Adherent to the Treatment Regimen for Haemophilia A Over the Course of the Study by Adherence Category (<80% vs. ≥80% of Study Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'title': 'Adherence <80% of Weeks', 'measurements': [{'value': '72', 'groupId': 'OG000'}]}, {'title': 'Adherence ≥80% of Weeks', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The adherence to the treatment regimen for haemophilia A was analyzed as the number of participants with \\<80% or ≥80% of weeks on study with "Yes" and "My therapeutic plan does not include any treatment in the last week" over the total number of weeks reported via the ePRO. Missing data from some weeks was treated as "No". The total number of weeks on study for each participant was derived as (End of study date - Baseline date + 1) / 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. A total of 4 participants had missing data and were excluded from this analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants by the Product of Concomitant Medications Taken to Control Pain Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Etoricoxib', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Paracetamol', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and every 3 months until study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity, as Reported by Participants Using a Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.24', 'groupId': 'OG000', 'lowerLimit': '10.09', 'upperLimit': '18.39'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.38', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '23.26'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.91', 'groupId': 'OG000', 'lowerLimit': '11.97', 'upperLimit': '21.85'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.53', 'groupId': 'OG000', 'lowerLimit': '12.77', 'upperLimit': '22.28'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.77', 'groupId': 'OG000', 'lowerLimit': '16.10', 'upperLimit': '27.44'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.76', 'groupId': 'OG000', 'lowerLimit': '13.37', 'upperLimit': '24.15'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.98', 'groupId': 'OG000', 'lowerLimit': '13.99', 'upperLimit': '23.97'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.89', 'groupId': 'OG000', 'lowerLimit': '14.19', 'upperLimit': '25.59'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.85', 'groupId': 'OG000', 'lowerLimit': '12.17', 'upperLimit': '23.54'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.58', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '23.36'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.20', 'groupId': 'OG000', 'lowerLimit': '12.75', 'upperLimit': '23.65'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.26', 'groupId': 'OG000', 'lowerLimit': '14.31', 'upperLimit': '26.22'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.85', 'groupId': 'OG000', 'lowerLimit': '13.88', 'upperLimit': '25.82'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.50', 'groupId': 'OG000', 'lowerLimit': '-18.53', 'upperLimit': '77.53'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.40', 'groupId': 'OG000', 'lowerLimit': '-2.85', 'upperLimit': '45.65'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.75', 'groupId': 'OG000', 'lowerLimit': '-2.97', 'upperLimit': '44.47'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.50', 'groupId': 'OG000', 'lowerLimit': '-146.33', 'upperLimit': '171.33'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '-175.59', 'upperLimit': '205.59'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '-11.71', 'upperLimit': '13.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'Participants reported the intensity of pain in their main joints (elbow, knee, ankle) by marking on a visual analogue scale (VAS), a horizontal line 100 millimeters (mm) in length, anchored by word descriptors at each end, where the left extreme means "No pain = 0" while the right extreme means "Worst Pain Imaginable = 100". The VAS score is the distance (in mm) from the left end of the line to the point where the participant marks crossed the line. VAS scale was submitted to the participants every month during the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Health-Related Quality of Life (HRQoL): European Quality of Life-5 Dimensions (EQ-5D-5L) Health State Utility Index Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '0.94'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.89', 'comment': 'Due to low number of participants, upper and lower limits of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '0.93'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '0.98'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '1.76'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '0.92'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.01'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '0.95'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '0.91'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.97'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '0.92'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '0.96'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.62', 'comment': 'Due to low number of participants, upper and lower limits of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '0.93'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.85', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '2.14'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.92', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L includes five levels of severity in each of the five EuroQol-5D dimensions and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. EQ-5D-5L questionnaire was submitted to the participants every 3 month from baseline during the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Health Status Measured Over Time, as Reported by Participants Using EQ-5D VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '86'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '85.0'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '97.6'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.5', 'groupId': 'OG000', 'lowerLimit': '-75.3', 'upperLimit': '242.3'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '70.1', 'upperLimit': '81.4'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '98.4'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '71.3', 'upperLimit': '85.6'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '83.5'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '105'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '82.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '83.7'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '109.8'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '-105.6', 'upperLimit': '275.6'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': "The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and the other section is an evaluation of the overall health status using VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS from 0 to 100 on how good or bad their health is at assessment; 0 means the worst health imaginable, and 100 means the best health imaginable.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Haemophilia Joint Health Score (HJHS) Total Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '12.7'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '23.8'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '17.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'The HJHS is an instrument developed to measure joint health status and to identify early signs of joint disease in children. This tool assesses joints most commonly affected by bleeding (knees, ankles, and elbows). Each of the 6 joints is assessed across 8 domains (Swelling, Duration of Swelling, Atrophy, Crepitus, Flexion Loss, Extension Loss, Pain, and Strength), and a Total Score is calculated as the sum of all joint domain scores. The score range is from 0 to 124 points (a score of 0 indicates no joint damage). A higher score indicates higher joint damage.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Mean Body Mass Index (BMI) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.34', 'groupId': 'OG000', 'lowerLimit': '22.64', 'upperLimit': '24.05'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.56', 'groupId': 'OG000', 'lowerLimit': '22.26', 'upperLimit': '24.86'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.42', 'groupId': 'OG000', 'lowerLimit': '22.02', 'upperLimit': '24.82'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.76', 'groupId': 'OG000', 'lowerLimit': '21.31', 'upperLimit': '26.21'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.98', 'groupId': 'OG000', 'lowerLimit': '21.88', 'upperLimit': '24.07'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 9, 12, 15 and 18', 'unitOfMeasure': 'kilogram per square meter (kg/m2)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Days Away From School or Work for Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from school or work (participant) was analyzed every month as a continuous variable. The yearly rate was derived on a per participant basis as the proportion between the total number of days away from school and/or work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Days Away From Work for Parent/Caregiver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from work was analyzed every month as a continuous variable. The yearly rate was derived on a per participant (for parents and caregivers) basis as the proportion between the total number of days away from work and duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Hospitalization Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The yearly rate was derived on a per participant basis as the proportion between the total number of hospitalization days and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Age of Possible Early Retirement of Caregiver, as Reported by Caregivers in a Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '77.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'unitOfMeasure': 'years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Active Versus Sedentary Participants by the Severity (Moderate or Severe) of Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Sedentary Participants', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Active Participants', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to study completion (up to 18 months)', 'description': 'Participants who were adherent to the WHO guidelines for physical activity according to the below definition were defined as an "active participant", otherwise as a "sedentary participant". A participant was defined "adherent" to WHO guidelines according to the following algorithm: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). The participants were classified as \'Active\' or \'Sedentary\' based on data collected from baseline till the end of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Annualized Bleeding Rates (ABR) in Active Versus Sedentary Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.945', 'groupId': 'OG000', 'lowerLimit': '1.481', 'upperLimit': '2.509'}, {'value': '1.384', 'groupId': 'OG001', 'lowerLimit': '0.974', 'upperLimit': '1.907'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'The annualized bleeding rate was derived as follows: total number of bleeds/total follow-up (person-year), where the individual\'s study duration was given by (\\[end of study date-baseline date +1\\] divided by 365.25). ABR was reported in active and sedentary participants. A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes).', 'unitOfMeasure': 'rate of bleeds per person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity in Active Versus Sedentary Participants, as Reported by Participants Using a Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.86', 'groupId': 'OG000', 'lowerLimit': '8.84', 'upperLimit': '26.87'}, {'value': '14.12', 'groupId': 'OG001', 'lowerLimit': '4.80', 'upperLimit': '23.44'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.29', 'groupId': 'OG000', 'lowerLimit': '11.95', 'upperLimit': '30.63'}, {'value': '15.73', 'groupId': 'OG001', 'lowerLimit': '7.03', 'upperLimit': '24.43'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.32', 'groupId': 'OG000', 'lowerLimit': '10.83', 'upperLimit': '25.81'}, {'value': '16.75', 'groupId': 'OG001', 'lowerLimit': '6.89', 'upperLimit': '26.61'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.80', 'groupId': 'OG000', 'lowerLimit': '14.38', 'upperLimit': '31.22'}, {'value': '17.17', 'groupId': 'OG001', 'lowerLimit': '7.82', 'upperLimit': '26.53'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.56', 'groupId': 'OG000', 'lowerLimit': '17.11', 'upperLimit': '38.01'}, {'value': '24.22', 'groupId': 'OG001', 'lowerLimit': '11.83', 'upperLimit': '36.61'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.28', 'groupId': 'OG000', 'lowerLimit': '13.28', 'upperLimit': '33.28'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '8.69', 'upperLimit': '31.31'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.09', 'groupId': 'OG000', 'lowerLimit': '13.13', 'upperLimit': '35.04'}, {'value': '20.67', 'groupId': 'OG001', 'lowerLimit': '10.73', 'upperLimit': '30.61'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.52', 'groupId': 'OG000', 'lowerLimit': '12.16', 'upperLimit': '32.89'}, {'value': '20.78', 'groupId': 'OG001', 'lowerLimit': '10.90', 'upperLimit': '30.67'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.02', 'groupId': 'OG000', 'lowerLimit': '10.81', 'upperLimit': '33.23'}, {'value': '19.98', 'groupId': 'OG001', 'lowerLimit': '8.34', 'upperLimit': '31.61'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.80', 'groupId': 'OG000', 'lowerLimit': '7.43', 'upperLimit': '28.18'}, {'value': '24.81', 'groupId': 'OG001', 'lowerLimit': '13.64', 'upperLimit': '35.97'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.16', 'groupId': 'OG000', 'lowerLimit': '8.92', 'upperLimit': '31.40'}, {'value': '20.98', 'groupId': 'OG001', 'lowerLimit': '11.65', 'upperLimit': '30.30'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.72', 'groupId': 'OG000', 'lowerLimit': '10.23', 'upperLimit': '31.21'}, {'value': '21.09', 'groupId': 'OG001', 'lowerLimit': '11.97', 'upperLimit': '30.21'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.68', 'groupId': 'OG000', 'lowerLimit': '10.94', 'upperLimit': '34.43'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '12.11', 'upperLimit': '37.89'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.50', 'groupId': 'OG000', 'lowerLimit': '-87.80', 'upperLimit': '102.80'}, {'value': '51.50', 'groupId': 'OG001', 'lowerLimit': '-183.56', 'upperLimit': '286.56'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'groupId': 'OG000', 'lowerLimit': '-10.64', 'upperLimit': '27.31'}, {'value': '33', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'groupId': 'OG000', 'lowerLimit': '-21.28', 'upperLimit': '54.61'}, {'value': '33', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'groupId': 'OG000', 'lowerLimit': '-146.33', 'upperLimit': '171.33'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '-175.59', 'upperLimit': '205.59'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-11.71', 'upperLimit': '13.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'Participants reported intensity of pain in their main joints (elbow, knee, ankle) by marking on a VAS, a horizontal line 100 mm in length, anchored by word descriptors at each end, where the left extreme means "No pain = 0" while right extreme means "Worst Pain Imaginable = 100". VAS score is the distance (in mm) from left end of the line to the point where participant marks crossed the line. A participant who was adherent to WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day ≥60 minutes. 18-50 years old: Fairly active (moderate) minutes per week ≥150 minutes or Very active (vigorous) minutes per week ≥75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). VAS scale was submitted to the participants every month during the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Active Versus Sedentary Participants by the Product of Concomitant Medications Taken to Control Pain Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activities guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activities guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Etoricoxib', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Paracetamol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and every 3 months until study completion (up to 18 months)', 'description': 'A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). Participants can have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Active Versus Sedentary Participants by the Type of Regimen Used for Treatment of Haemophilia A Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Prophylaxis for Haemophilia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'On Demand for Haemophilia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The following types of regimens used to treat haemophilia A are reported here: on-demand (to stop bleeding) and prophylaxis (regular infusions of clotting factor to prevent bleeds). A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). Participants can have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Active Versus Sedentary Participants by the Product Used for Treatment of Haemophilia A Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Prophylaxis for Haemophilia: Octocog Alfa', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Efmoroctocog Alfa', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Moroctocog Alfa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Turoctocog Alfa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Lonoctocog Alfa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Rurioctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Simoctocog Alfa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Turoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Damoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Factor VIII (Antihemophilic Factor)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Emicizumab', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis for Haemophilia: Tranexamic Acid', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'On Demand for Haemophilia: Octocog Alfa', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Active Versus Sedentary Participants Who Switched to a New Approved Drug for Treatment of Haemophilia A by the Product Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Turoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Damoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rurioctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Emicizumab', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to the time of switch to a new therapy (up to 18 months)', 'description': 'A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'HRQoL: EQ-5D-5L Health State Utility Index Score Over Time for Active Versus Sedentary Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '0.94'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '0.95'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '0.93'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '0.94'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '1.57'}, {'value': '1', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.92'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '0.93'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '0.99'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '1.76'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '0.94'}, {'value': '0.91', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '0.95'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '0.91'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '0.94'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '0.94'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '0.93'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '0.98'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '1.06'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.62', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.39'}, {'value': '0.86', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated..', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '2.14'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'EQ-5D-5L is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L includes five levels of severity in each of five EuroQol-5D dimensions and EQ VAS. Descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Response options are measured with a 5-point Likert scale. 5D-5L systems are converted into a single index utility score between 0-1, where higher score indicates a better health state and lower score indicate worse health state. A participant who was adherent to WHO guidelines for physical activity was defined as an "active participant", otherwise as a "sedentary participant". EQ-5D-5L questionnaire was submitted to participants every 3 month from baseline during the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Health Status Measured Over Time, as Reported by Participants Using EQ-5D VAS Score in Active Versus Sedentary Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '86.8'}, {'value': '78.1', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '89.5'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.0', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '68.7', 'upperLimit': '85.1'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '89.3'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '-174.1', 'upperLimit': '334.1'}, {'value': '97.0', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '62.8', 'upperLimit': '83.4'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '67.3', 'upperLimit': '84.9'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '30.7', 'upperLimit': '94.3'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '-389.7', 'upperLimit': '499.7'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '70.2', 'upperLimit': '90.2'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '66.8', 'upperLimit': '91.5'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '88.4'}, {'value': '67.0', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '89.9'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '74.5', 'upperLimit': '88.9'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '53.7', 'upperLimit': '79.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '88.4'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '99.0'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.0', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '129.3'}, {'value': '67.0', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '-105.6', 'upperLimit': '275.6'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'comment': 'Since only one participants was evaluated upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities pain/discomfort, anxiety/depression) and the other section is an evaluation of the overall health status using VAS. The VAS records the respondent\'s self-rated health on a 20 centimeter (cm) vertical VAS from 0 to 100 on how good or bad their health is at assessment; 0 means the worst health imaginable, and 100 means the best health imaginable. A participant who was adherent to the WHO guidelines for physical activity was defined as an "active participant", otherwise as a "sedentary participant".', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'HJHS Total Score for Active Versus Sedentary Participants Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '18.4'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '18.0'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '-7.3', 'upperLimit': '66.0'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '14.4'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '29.9'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '24.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'The HJHS is an instrument developed to measure joint health status and to identify early signs of joint disease in children. This tool assesses joints most commonly affected by bleeding (knees, ankles, and elbows). Each of the 6 joints is assessed across 8 domains (Swelling, Duration of Swelling, Atrophy, Crepitus, Flexion Loss, Extension Loss, Pain, and Strength), and a Total Score is calculated as the sum of all joint domain scores. The score range is from 0 to 124 points (a score of 0 indicates no joint damage). A higher score indicates higher joint damage.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study. Number analyzed is the number of participants with data available for analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Number of Days Away From School/Work for Active Versus Sedentary Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '57'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from school or work (participant) was analyzed every month as a continuous variable. The yearly rate was derived on a per participant basis as the proportion between the total number of days away from school and/or work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': "Yearly Rate of Number of Days Away From Work for Active Versus Sedentary Participant's Parents or Caregivers", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '57'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from work was analyzed every month as a continuous variable. The yearly rate was derived on a per participant (for parents/caregivers) basis as the proportion between the total number of days away from work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Number of Hospitalization Days for Active Versus Sedentary Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months"}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activities guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The yearly rate was derived on a per participant basis as the proportion between the total number of hospitalization days and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all enrolled participants with at least 6 valid months of physical activity evaluations during the study.'}, {'type': 'SECONDARY', 'title': 'Annualized Bleeding Rates in Active Versus Sedentary Participants by the Severity (Moderate Versus Severe) of Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary Participants', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Sedentary' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Active Participants', 'description': "Participants severe or moderate Haemophilia A without inhibitors against Factor VIII, who classified as 'Active' per WHO physical activity guideline, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Moderate Haemophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.368', 'groupId': 'OG000', 'lowerLimit': '0.009', 'upperLimit': '2.049'}, {'value': '2.536', 'groupId': 'OG001', 'lowerLimit': '1.095', 'upperLimit': '4.998'}]}]}, {'title': 'Severe Haemophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.517', 'groupId': 'OG000', 'lowerLimit': '1.212', 'upperLimit': '1.876'}, {'value': '1.035', 'groupId': 'OG001', 'lowerLimit': '0.717', 'upperLimit': '1.446'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'The annualized bleeding rate was derived as follows: total number of bleeds/total follow-up (person-year), where the individual\'s study duration was given by (\\[end of study date-baseline date +1\\] divided by 365.25). A participant who was adherent to the WHO guidelines for physical activity was defined as an "active participant", otherwise as a "sedentary participant". Participants were classified for disease severity at baseline: severe (Factor VIII activity \\<1%) or moderate (Factor VIII activity between ≥1% and ≤2%) haemophilia A.', 'unitOfMeasure': 'rate of bleeds per person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number of participants analyzed is the number of participants with available physical activities data in ITT population for sedentary and active participants.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity in Participants With Moderate Versus Severe Haemophilia A, as Reported by Participants Using a Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.33', 'groupId': 'OG000', 'lowerLimit': '-5.34', 'upperLimit': '52.01'}, {'value': '13.66', 'groupId': 'OG001', 'lowerLimit': '9.46', 'upperLimit': '17.86'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.67', 'groupId': 'OG000', 'lowerLimit': '-8.87', 'upperLimit': '56.20'}, {'value': '17.96', 'groupId': 'OG001', 'lowerLimit': '13.03', 'upperLimit': '22.90'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.20', 'groupId': 'OG000', 'lowerLimit': '-19.80', 'upperLimit': '58.20'}, {'value': '16.75', 'groupId': 'OG001', 'lowerLimit': '11.76', 'upperLimit': '21.75'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.00', 'groupId': 'OG000', 'lowerLimit': '-14.78', 'upperLimit': '56.78'}, {'value': '17.29', 'groupId': 'OG001', 'lowerLimit': '12.46', 'upperLimit': '22.12'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.00', 'groupId': 'OG000', 'lowerLimit': '-9.87', 'upperLimit': '67.87'}, {'value': '21.28', 'groupId': 'OG001', 'lowerLimit': '15.48', 'upperLimit': '27.09'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.20', 'groupId': 'OG000', 'lowerLimit': '-10.17', 'upperLimit': '62.57'}, {'value': '18.20', 'groupId': 'OG001', 'lowerLimit': '12.69', 'upperLimit': '23.70'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.40', 'groupId': 'OG000', 'lowerLimit': '-1.01', 'upperLimit': '53.81'}, {'value': '18.45', 'groupId': 'OG001', 'lowerLimit': '13.27', 'upperLimit': '23.63'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.75', 'groupId': 'OG000', 'lowerLimit': '-15.94', 'upperLimit': '73.44'}, {'value': '19.29', 'groupId': 'OG001', 'lowerLimit': '13.46', 'upperLimit': '25.12'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.63', 'groupId': 'OG000', 'lowerLimit': '-17.84', 'upperLimit': '73.09'}, {'value': '17.21', 'groupId': 'OG001', 'lowerLimit': '11.41', 'upperLimit': '23.02'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000', 'lowerLimit': '-13.29', 'upperLimit': '47.29'}, {'value': '17.64', 'groupId': 'OG001', 'lowerLimit': '11.58', 'upperLimit': '23.70'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.38', 'groupId': 'OG000', 'lowerLimit': '7.30', 'upperLimit': '31.45'}, {'value': '18.12', 'groupId': 'OG001', 'lowerLimit': '12.33', 'upperLimit': '23.91'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.50', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '22.25'}, {'value': '20.95', 'groupId': 'OG001', 'lowerLimit': '14.57', 'upperLimit': '27.33'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.33', 'groupId': 'OG000', 'lowerLimit': '-3.75', 'upperLimit': '42.41'}, {'value': '19.88', 'groupId': 'OG001', 'lowerLimit': '13.60', 'upperLimit': '26.16'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.00', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.00', 'groupId': 'OG001', 'lowerLimit': '-25.04', 'upperLimit': '57.04'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.40', 'groupId': 'OG001', 'lowerLimit': '-2.85', 'upperLimit': '45.65'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.75', 'groupId': 'OG001', 'lowerLimit': '-2.97', 'upperLimit': '44.47'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'groupId': 'OG001', 'lowerLimit': '-146.33', 'upperLimit': '171.33'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.00', 'groupId': 'OG001', 'lowerLimit': '-175.59', 'upperLimit': '205.59'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '-11.71', 'upperLimit': '13.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 and 18', 'description': 'Participants reported the intensity of pain in their main joints (elbow, knee, ankle) by marking on a VAS, a horizontal line 100 mm in length, anchored by word descriptors at each end, where the left extreme means "No pain = 0" while the right extreme means "Worst Pain Imaginable = 100". The VAS score is the distance (in mm) from the left end of the line to the point where the participant marks crossed the line. VAS scale was submitted to the participants every month during the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate Versus Severe Haemophilia A by the Product of Concomitant Medications Taken to Control Pain Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Etoricoxib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Paracetamol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and every 3 months until study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate Versus Severe Haemophilia A by the Type of Regimen Used for Treatment of Haemophilia A Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Prophylaxis for Haemophilia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'On Demand for Haemophilia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The following types of regimens used to treat haemophilia A are reported here: on-demand (to stop bleeding) and prophylaxis (regular infusions of clotting factor to prevent bleeds). Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate Versus Severe Haemophilia A by the Product Used for Treatment of Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Prophylaxis; Octocog Alfa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Efmoroctocog Alfa', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Moroctocog Alfa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Turoctocog Alfa', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Lonoctocog Alfa', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Rurioctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Damoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Simoctocog Alfa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Turoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Factor VIII (Antihaemophilic Factor)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Factor VIII, Recombinant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Emicizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Desmopressin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prophylaxis; Tranexamic Acid', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'On Demand; Octocog Alfa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate Versus Severe Haemophilia A Who Switched to a New Approved Drug for Treatment of Haemophilia A by the Product Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants who were 12-17 years of Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Turoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Damoctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Rurioctocog Alfa Pegol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Emicizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to the time of switch to a new therapy (up to 18 months)', 'description': 'Participants could have received more than one medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker.'}, {'type': 'SECONDARY', 'title': 'HRQoL: EQ-5D-5L Health State Utility Index Score Over Time Moderate Versus Severe Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.0'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.91', 'upperLimit': '0.94'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.09'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '0.93'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '0.99'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '1.76'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.05'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '0.92'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '1.01'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.03'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '0.95'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '1.18'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '0.91'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.62', 'upperLimit': '0.97'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.01'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '0.92'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '0.96'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.62', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.79', 'upperLimit': '0.93'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '2.14'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L includes five levels of severity in each of the five EuroQol-5D dimensions and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. EQ-5D-5L questionnaire was submitted to the participants every 3 month from baseline during the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Health Status Measured Over Time, as Reported by Participants Using EQ-5D VAS Score in Participants With Moderate Versus Severe Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '103.8'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '77.2', 'upperLimit': '85.8'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '107.8'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '76.0', 'upperLimit': '85.1'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '87.6', 'groupId': 'OG001', 'lowerLimit': '74.4', 'upperLimit': '100.7'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '-75.3', 'upperLimit': '242.3'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '97.0'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '81.1'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '98.4'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '-358.6', 'upperLimit': '454.6'}, {'value': '79.7', 'groupId': 'OG001', 'lowerLimit': '72.8', 'upperLimit': '86.7'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '119.7'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '60.6', 'upperLimit': '83.5'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '40.0', 'upperLimit': '105.0'}]}]}, {'title': 'Month 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '126.0'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '82.4'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '83.7'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '56.7', 'upperLimit': '109.8'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '-105.6', 'upperLimit': '275.6'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': "The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and the other section is an evaluation of the overall health status using VAS. The VAS records the respondent's self-rated health on a 20 cm vertical VAS from 0 to 100 on how good or bad their health is at assessment; 0 means the worst health imaginable, and 100 means the best health imaginable.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoint.'}, {'type': 'SECONDARY', 'title': 'HJHS Total Score for Participants With Moderate Versus Severe Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '17.8'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '12.9'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '24'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'comment': 'Since only one participant was evaluated, upper and lower limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '17.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'The HJHS is an instrument developed to measure joint health status and to identify early signs of joint disease in children. This tool assesses joints most commonly affected by bleeding (knees, ankles, and elbows). Each of the 6 joints is assessed across 8 domains (Swelling, Duration of Swelling, Atrophy, Crepitus, Flexion Loss, Extension Loss, Pain, and Strength), and a Total Score is calculated as the sum of all joint domain scores. The total score range is from 0 to 124 points (a score of 0 indicates no joint damage). A higher score indicates higher joint damage.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Days Away From School for Participants With Moderate Versus Severe Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from school or work (participant) was analyzed every month as a continuous variable. The yearly rate was derived on a per participant basis as the proportion between the total number of days away from school and/or work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Days Away From Work for Parents/Caregivers of Participants With Moderate Versus Severe Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from work was analyzed every month as a continuous variable. The yearly rate was derived on a per participant (for parents/caregivers) basis as the proportion between the total number of days away from work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Yearly Rate of Hospitalization Days for Participants With Moderate Versus Severe Haemophilia A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Haemophilia A', 'description': "Participants with moderate Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}, {'id': 'OG001', 'title': 'Severe Haemophilia A', 'description': "Participants with severe Haemophilia A without inhibitors against Factor VIII receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The yearly rate was derived on a per participant basis as the proportion between the total number of hospitalization days and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.', 'unitOfMeasure': 'days/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received the ePRO application and the fitness tracker. Overall number analyzed is the number of participants with data available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Participants withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': '107 patients were screened, but 4 patients did not meet the eligibility criteria; in total, 103 participants were enrolled and started the study. Participants took part in this study at 17 investigative sites in Italy from 24 February 2020 up to 28 April 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care for Haemophilia A', 'description': "Participants with severe or moderate Haemophilia A without inhibitors against Factor VIII, receiving standard of care treatment, independently of participation in the current study, according to clinician's independent therapeutic decision were enrolled for a maximum observation period of 18 months."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Is Haemophilia A diagnosis confirmed', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Severity type', 'classes': [{'categories': [{'title': 'Moderate Haemophilia', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Severe Haemophilia', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-To-Treat (ITT) population included all enrolled participants who received the electronic patient-reported outcome (ePRO) application and the fitness tracker.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-31', 'size': 1119862, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-27T08:26', 'hasProtocol': True}, {'date': '2022-07-22', 'size': 1132014, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-27T08:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2019-10-31', 'resultsFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-31', 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Daily Active Minutes of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Physical activity data was collected as daily active minutes measured on each valid day by wearing a fitness tracker continuously during study participation. Valid day = a day in which fitness tracker was worn for at least 10 hours. Daily active minutes were saved in two different sets of data collected by fitness tracker. For each set minutes were categorized by intensity of activity done. First set = minutes categorized according to time collected in each heart zone. Overall heart zone minutes = fat-burn minutes (heart rate: 50-69% of maximum) + cardio minutes (medium-to-high intensity exercise zone corresponds to heart rate: 70-84% of maximum) + peak minutes (high-intensity exercise zone, corresponds to heart rate \\> 85% of maximum). Second set =minutes categorized according to active zones. Overall active zone minutes=lightly active minutes +fairly active minutes+very active minutes. Moderate-to-Vigorous Physical Activity (MVPA) minutes=Fairly active minutes+Very active minutes.'}, {'measure': 'Mean Number of Steps Taken Per Day by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Number of steps taken by the participants on each valid day were measured by wearing a fitness tracker continuously during study participation. Valid day was defined as a day in which fitness tracker was worn for at least 10 hours.'}, {'measure': 'Mean Metabolic Equivalent of Tasks (METs) Per Day Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The MET is an objective measure of the ratio of the rate at which a person expends energy, relative to the mass of that person, while performing some specific physical activity compared to a reference. The METs were derived as: (amount of kilo calories (kcal) collected in the fat-burn, cardio, and peak minutes) / \\[(sum of fat-burn, cardio and peak hours) \\* weight of the participant in kilograms (kg)\\].'}], 'secondaryOutcomes': [{'measure': 'Mean Rate of the Number of Times Engaging in Physical Activity Per Week by Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The activity weekly rate was derived on a per participant basis as ratio between the number of times that the type of activity is reported on the fitness tracker (numerator) and the length of the observational period (i.e. end of study date - baseline date + 1) (denominator) and then multiplied by 7. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.'}, {'measure': 'Mean Active Minutes by Intensity (Lightly Active Minutes) for Each Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The number of active minutes by intensity (lightly, fairly, and very active minutes) were obtained at the participant level on a per activity basis as the median of the values collected by the fitness tracker for each activity recorded during the observational period. In this analysis, the means and 95% confidence intervals were calculated using the median lightly active minutes by type of physical activity performed by participants with available data. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.'}, {'measure': 'Mean Active Minutes by Intensity (Fairly Active Minutes) for Each Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The number of active minutes by intensity (lightly, fairly, and very active minutes) were obtained at the participant level on a per activity basis as the median of the values collected by the fitness tracker for each activity recorded during the observational period. In this analysis, the means and 95% confidence intervals were calculated using the median fairly active minutes by type of physical activity performed by participants with available data. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.'}, {'measure': 'Mean Active Minutes by Intensity (MVPA Minutes) for Each Type of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The number of active minutes by intensity (lightly, fairly, and very active minutes) were obtained at the participant level on a per activity basis as the median of the values collected by the fitness tracker for each activity recorded during the observational period. The MVPA minutes is the sum of fairly active and very active minutes. In this analysis, the means and 95% confidence intervals were calculated using the median MVPA minutes by type of physical activity performed by participants with available data. The physical activities were categorized in the following groups: exercises at intervals, gym weights, running, swimming, tapis roulant, walk, general exercises: other types of physical activity identified by the fitness tracker that are not already included in the above-mentioned categories.'}, {'measure': 'Percentage of Participants Who Were Adherent to World Health Organization (WHO) Global Recommendations on Physical Activity for Health Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'A participant was defined "adherent" to WHO guidelines according to the following algorithm: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). A participant who was adherent to the WHO guidelines according to the above definition was defined as an "active participant", otherwise as a "sedentary participant".'}, {'measure': 'Number of Participants by the Presence of Bleeds (0 vs. ≥1 Bleeds) Over the Course of the Study, Reported Via the ePRO Application', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'Bleeds that occurred the same day but in different body site were counted separately.'}, {'measure': 'Number of Participants by the Presence of Bleeds (0 vs. ≥1 Bleeds) Over the Course of the Study According to the Different Types of Bleeds (Spontaneous, Traumatic and Procedure/Surgery Related), Reported Via the ePRO Application', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months).', 'description': 'The assessment of bleeds was divided into spontaneous bleeds, traumatic bleeds, and bleeds related to procedure/surgery. Spontaneous bleeds = the occurrence of hemorrhage where neither the participant nor a caregiver could identify a reason. Traumatic bleeds = hemorrhage occurring secondary to an event such as trauma, "strenuous" activity, or "overuse". Bleeds related to procedure/surgery = such as hematomas resulting from any surgeries or invasive procedures.'}, {'measure': 'Number of Participants by the Presence of Bleeds (0 vs. ≥1 Bleeds) Over the Course of the Study According to the Bleed Sites (Urine, Feces, and Vomit, Joint, Muscle, and Other Bleeds), Reported Via the ePRO Application', 'timeFrame': 'Baseline and whenever bleeding occured from study initiation to completion (up to 18 months)', 'description': 'Sites of bleeds were defined as urine, faeces, and vomit (three sites grouped together), joint, muscle, and other bleeds.'}, {'measure': 'Number of Participants by the Type of Regimen Used for Treatment of Haemophilia A Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The following types of regimens used to treat haemophilia A are reported here: on-demand (to stop bleeding) and prophylaxis (regular infusions of clotting factor to prevent bleeds). Participants could have received more than one medication.'}, {'measure': 'Number of Participants by the Product Used for Treatment of Haemophilia A Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.'}, {'measure': 'Number of Participants Who Switched to a New Approved Drug for Treatment of Haemophilia A by the Product Used', 'timeFrame': 'From baseline to the time of switch to a new therapy (up to 18 months)', 'description': 'Participants could have received more than one medication.'}, {'measure': 'Number of Treated Bleeds Over the Course of the Study', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'An event was considered a treated bleed if coagulation factors were administered to treat signs or symptoms of bleeding (e.g., pain, swelling, etc.).'}, {'measure': 'Number of Bleeds Treated With Each Type of Treatment for Bleeding (Haemostatic Treatment, Treatment for Pain)', 'timeFrame': 'From baseline to whenever bleeding occurred (up to 18 months)', 'description': 'An event was considered a treated bleed if coagulation factors were administered to treat signs or symptoms of bleeding (e.g., pain, swelling, etc.).'}, {'measure': 'Duration of Treatment for Bleeding Over the Course of the Study', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)'}, {'measure': 'Number of Bleeds Treated With Each Route of Administration Over the Course of the Study', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'Number of bleeds treated by intravenous, subcutaneous, intramuscular, nasal, ophthalmic, oral, rectal, and other routes of administration are reported here.'}, {'measure': 'Number of Bleeds Which Needed to Receive a Transfusion', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)'}, {'measure': 'Number of Bleeds Which Needed to Administer an Additional Hemostatic Therapy', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)'}, {'measure': 'Number of Bleeds With Adherence to Treatment Regimen for Haemophilia A in the Week Preceding the Bleeding', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'The adherence to the treatment regimen for haemophilia A was analyzed as the number of bleeds with an answer equal to "Yes" and "My therapeutic plan does not include any treatment in the last week" in the week preceding the bleeding.'}, {'measure': 'Number of Participants Who Were Adherent to the Treatment Regimen for Haemophilia A Over the Course of the Study by Adherence Category (<80% vs. ≥80% of Study Weeks)', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The adherence to the treatment regimen for haemophilia A was analyzed as the number of participants with \\<80% or ≥80% of weeks on study with "Yes" and "My therapeutic plan does not include any treatment in the last week" over the total number of weeks reported via the ePRO. Missing data from some weeks was treated as "No". The total number of weeks on study for each participant was derived as (End of study date - Baseline date + 1) / 7.'}, {'measure': 'Number of Participants by the Product of Concomitant Medications Taken to Control Pain Over the Course of the Study', 'timeFrame': 'Baseline and every 3 months until study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.'}, {'measure': 'Pain Intensity, as Reported by Participants Using a Visual Analogue Scale', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'Participants reported the intensity of pain in their main joints (elbow, knee, ankle) by marking on a visual analogue scale (VAS), a horizontal line 100 millimeters (mm) in length, anchored by word descriptors at each end, where the left extreme means "No pain = 0" while the right extreme means "Worst Pain Imaginable = 100". The VAS score is the distance (in mm) from the left end of the line to the point where the participant marks crossed the line. VAS scale was submitted to the participants every month during the study.'}, {'measure': 'Health-Related Quality of Life (HRQoL): European Quality of Life-5 Dimensions (EQ-5D-5L) Health State Utility Index Score Over Time', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L includes five levels of severity in each of the five EuroQol-5D dimensions and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. EQ-5D-5L questionnaire was submitted to the participants every 3 month from baseline during the study.'}, {'measure': 'Health Status Measured Over Time, as Reported by Participants Using EQ-5D VAS Score', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': "The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and the other section is an evaluation of the overall health status using VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS from 0 to 100 on how good or bad their health is at assessment; 0 means the worst health imaginable, and 100 means the best health imaginable."}, {'measure': 'Haemophilia Joint Health Score (HJHS) Total Score Over Time', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'The HJHS is an instrument developed to measure joint health status and to identify early signs of joint disease in children. This tool assesses joints most commonly affected by bleeding (knees, ankles, and elbows). Each of the 6 joints is assessed across 8 domains (Swelling, Duration of Swelling, Atrophy, Crepitus, Flexion Loss, Extension Loss, Pain, and Strength), and a Total Score is calculated as the sum of all joint domain scores. The score range is from 0 to 124 points (a score of 0 indicates no joint damage). A higher score indicates higher joint damage.'}, {'measure': 'Mean Body Mass Index (BMI) Over Time', 'timeFrame': 'Baseline, Months 3, 6, 9, 12, 15 and 18'}, {'measure': 'Yearly Rate of Days Away From School or Work for Participants', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from school or work (participant) was analyzed every month as a continuous variable. The yearly rate was derived on a per participant basis as the proportion between the total number of days away from school and/or work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Yearly Rate of Days Away From Work for Parent/Caregiver', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from work was analyzed every month as a continuous variable. The yearly rate was derived on a per participant (for parents and caregivers) basis as the proportion between the total number of days away from work and duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Yearly Rate of Hospitalization Days', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The yearly rate was derived on a per participant basis as the proportion between the total number of hospitalization days and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Age of Possible Early Retirement of Caregiver, as Reported by Caregivers in a Questionnaire', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)'}, {'measure': 'Number of Active Versus Sedentary Participants by the Severity (Moderate or Severe) of Haemophilia A', 'timeFrame': 'From baseline up to study completion (up to 18 months)', 'description': 'Participants who were adherent to the WHO guidelines for physical activity according to the below definition were defined as an "active participant", otherwise as a "sedentary participant". A participant was defined "adherent" to WHO guidelines according to the following algorithm: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). The participants were classified as \'Active\' or \'Sedentary\' based on data collected from baseline till the end of the study.'}, {'measure': 'Annualized Bleeding Rates (ABR) in Active Versus Sedentary Participants', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'The annualized bleeding rate was derived as follows: total number of bleeds/total follow-up (person-year), where the individual\'s study duration was given by (\\[end of study date-baseline date +1\\] divided by 365.25). ABR was reported in active and sedentary participants. A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes).'}, {'measure': 'Pain Intensity in Active Versus Sedentary Participants, as Reported by Participants Using a Visual Analogue Scale', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'Participants reported intensity of pain in their main joints (elbow, knee, ankle) by marking on a VAS, a horizontal line 100 mm in length, anchored by word descriptors at each end, where the left extreme means "No pain = 0" while right extreme means "Worst Pain Imaginable = 100". VAS score is the distance (in mm) from left end of the line to the point where participant marks crossed the line. A participant who was adherent to WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day ≥60 minutes. 18-50 years old: Fairly active (moderate) minutes per week ≥150 minutes or Very active (vigorous) minutes per week ≥75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). VAS scale was submitted to the participants every month during the study.'}, {'measure': 'Number of Active Versus Sedentary Participants by the Product of Concomitant Medications Taken to Control Pain Over the Course of the Study', 'timeFrame': 'Baseline and every 3 months until study completion (up to 18 months)', 'description': 'A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). Participants can have received more than one medication.'}, {'measure': 'Number of Active Versus Sedentary Participants by the Type of Regimen Used for Treatment of Haemophilia A Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The following types of regimens used to treat haemophilia A are reported here: on-demand (to stop bleeding) and prophylaxis (regular infusions of clotting factor to prevent bleeds). A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes). Participants can have received more than one medication.'}, {'measure': 'Number of Active Versus Sedentary Participants by the Product Used for Treatment of Haemophilia A Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes).'}, {'measure': 'Number of Active Versus Sedentary Participants Who Switched to a New Approved Drug for Treatment of Haemophilia A by the Product Used', 'timeFrame': 'From baseline to the time of switch to a new therapy (up to 18 months)', 'description': 'A participant who was adherent to the WHO guidelines for physical activity according to the below definition was defined as an "active participant", otherwise as a "sedentary participant". WHO guidelines for adherence: 12-17 years old: MVPA minutes per day \\>= 60 minutes. 18-50 years old: Fairly active (moderate) minutes per week \\>= 150 minutes or Very active (vigorous) minutes per week \\>= 75 minutes or an equivalent combination of fairly and very active minutes (i.e., considering 1 fairly active minute as 0.5 very active minutes).'}, {'measure': 'HRQoL: EQ-5D-5L Health State Utility Index Score Over Time for Active Versus Sedentary Participants', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'EQ-5D-5L is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L includes five levels of severity in each of five EuroQol-5D dimensions and EQ VAS. Descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Response options are measured with a 5-point Likert scale. 5D-5L systems are converted into a single index utility score between 0-1, where higher score indicates a better health state and lower score indicate worse health state. A participant who was adherent to WHO guidelines for physical activity was defined as an "active participant", otherwise as a "sedentary participant". EQ-5D-5L questionnaire was submitted to participants every 3 month from baseline during the study.'}, {'measure': 'Health Status Measured Over Time, as Reported by Participants Using EQ-5D VAS Score in Active Versus Sedentary Participants', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities pain/discomfort, anxiety/depression) and the other section is an evaluation of the overall health status using VAS. The VAS records the respondent\'s self-rated health on a 20 centimeter (cm) vertical VAS from 0 to 100 on how good or bad their health is at assessment; 0 means the worst health imaginable, and 100 means the best health imaginable. A participant who was adherent to the WHO guidelines for physical activity was defined as an "active participant", otherwise as a "sedentary participant".'}, {'measure': 'HJHS Total Score for Active Versus Sedentary Participants Over Time', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'The HJHS is an instrument developed to measure joint health status and to identify early signs of joint disease in children. This tool assesses joints most commonly affected by bleeding (knees, ankles, and elbows). Each of the 6 joints is assessed across 8 domains (Swelling, Duration of Swelling, Atrophy, Crepitus, Flexion Loss, Extension Loss, Pain, and Strength), and a Total Score is calculated as the sum of all joint domain scores. The score range is from 0 to 124 points (a score of 0 indicates no joint damage). A higher score indicates higher joint damage.'}, {'measure': 'Yearly Rate of Number of Days Away From School/Work for Active Versus Sedentary Participants', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from school or work (participant) was analyzed every month as a continuous variable. The yearly rate was derived on a per participant basis as the proportion between the total number of days away from school and/or work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': "Yearly Rate of Number of Days Away From Work for Active Versus Sedentary Participant's Parents or Caregivers", 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from work was analyzed every month as a continuous variable. The yearly rate was derived on a per participant (for parents/caregivers) basis as the proportion between the total number of days away from work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Yearly Rate of Number of Hospitalization Days for Active Versus Sedentary Participants', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The yearly rate was derived on a per participant basis as the proportion between the total number of hospitalization days and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Annualized Bleeding Rates in Active Versus Sedentary Participants by the Severity (Moderate Versus Severe) of Haemophilia A', 'timeFrame': 'Baseline and whenever bleeding occurred from study initiation to completion (up to 18 months)', 'description': 'The annualized bleeding rate was derived as follows: total number of bleeds/total follow-up (person-year), where the individual\'s study duration was given by (\\[end of study date-baseline date +1\\] divided by 365.25). A participant who was adherent to the WHO guidelines for physical activity was defined as an "active participant", otherwise as a "sedentary participant". Participants were classified for disease severity at baseline: severe (Factor VIII activity \\<1%) or moderate (Factor VIII activity between ≥1% and ≤2%) haemophilia A.'}, {'measure': 'Pain Intensity in Participants With Moderate Versus Severe Haemophilia A, as Reported by Participants Using a Visual Analogue Scale', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 and 18', 'description': 'Participants reported the intensity of pain in their main joints (elbow, knee, ankle) by marking on a VAS, a horizontal line 100 mm in length, anchored by word descriptors at each end, where the left extreme means "No pain = 0" while the right extreme means "Worst Pain Imaginable = 100". The VAS score is the distance (in mm) from the left end of the line to the point where the participant marks crossed the line. VAS scale was submitted to the participants every month during the study.'}, {'measure': 'Number of Participants With Moderate Versus Severe Haemophilia A by the Product of Concomitant Medications Taken to Control Pain Over the Course of the Study', 'timeFrame': 'Baseline and every 3 months until study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.'}, {'measure': 'Number of Participants With Moderate Versus Severe Haemophilia A by the Type of Regimen Used for Treatment of Haemophilia A Over the Course of the Study', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'The following types of regimens used to treat haemophilia A are reported here: on-demand (to stop bleeding) and prophylaxis (regular infusions of clotting factor to prevent bleeds). Participants could have received more than one medication.'}, {'measure': 'Number of Participants With Moderate Versus Severe Haemophilia A by the Product Used for Treatment of Haemophilia A', 'timeFrame': 'From baseline to study completion (up to 18 months)', 'description': 'Participants could have received more than one medication.'}, {'measure': 'Number of Participants With Moderate Versus Severe Haemophilia A Who Switched to a New Approved Drug for Treatment of Haemophilia A by the Product Used', 'timeFrame': 'From baseline to the time of switch to a new therapy (up to 18 months)', 'description': 'Participants could have received more than one medication.'}, {'measure': 'HRQoL: EQ-5D-5L Health State Utility Index Score Over Time Moderate Versus Severe Haemophilia A', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': 'The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L includes five levels of severity in each of the five EuroQol-5D dimensions and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. EQ-5D-5L questionnaire was submitted to the participants every 3 month from baseline during the study.'}, {'measure': 'Health Status Measured Over Time, as Reported by Participants Using EQ-5D VAS Score in Participants With Moderate Versus Severe Haemophilia A', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18', 'description': "The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and the other section is an evaluation of the overall health status using VAS. The VAS records the respondent's self-rated health on a 20 cm vertical VAS from 0 to 100 on how good or bad their health is at assessment; 0 means the worst health imaginable, and 100 means the best health imaginable."}, {'measure': 'HJHS Total Score for Participants With Moderate Versus Severe Haemophilia A', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'The HJHS is an instrument developed to measure joint health status and to identify early signs of joint disease in children. This tool assesses joints most commonly affected by bleeding (knees, ankles, and elbows). Each of the 6 joints is assessed across 8 domains (Swelling, Duration of Swelling, Atrophy, Crepitus, Flexion Loss, Extension Loss, Pain, and Strength), and a Total Score is calculated as the sum of all joint domain scores. The total score range is from 0 to 124 points (a score of 0 indicates no joint damage). A higher score indicates higher joint damage.'}, {'measure': 'Yearly Rate of Days Away From School for Participants With Moderate Versus Severe Haemophilia A', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from school or work (participant) was analyzed every month as a continuous variable. The yearly rate was derived on a per participant basis as the proportion between the total number of days away from school and/or work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Yearly Rate of Days Away From Work for Parents/Caregivers of Participants With Moderate Versus Severe Haemophilia A', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The number of days away from work was analyzed every month as a continuous variable. The yearly rate was derived on a per participant (for parents/caregivers) basis as the proportion between the total number of days away from work and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}, {'measure': 'Yearly Rate of Hospitalization Days for Participants With Moderate Versus Severe Haemophilia A', 'timeFrame': 'Baseline and every month until study completion (up to 18 months)', 'description': 'The yearly rate was derived on a per participant basis as the proportion between the total number of hospitalization days and the duration of the study (derived as end of study date - baseline date + 1) multiplied by 365.25.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemophilia A', 'Factor VIII'], 'conditions': ['Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor', 'Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor', 'Haemophilia A']}, 'referencesModule': {'references': [{'pmid': '34855619', 'type': 'DERIVED', 'citation': 'Petracca F, Tempre R, Cucciniello M, Ciani O, Pompeo E, Sannino L, Lovato V, Castaman G, Ghirardini A, Tarricone R. An Electronic Patient-Reported Outcome Mobile App for Data Collection in Type A Hemophilia: Design and Usability Study. JMIR Form Res. 2021 Dec 1;5(12):e25071. doi: 10.2196/25071.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, non-interventional, prospective study will collect information about activity status, bleeds, health-related quality of life (HRQoL), health status, and safety in participants with moderate or severe haemophilia A without factor VIII (FVIII) inhibitors, who are being treated in accordance with normal clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 150 participants overall, 125 with severe haemophilia A and 25 with moderate haemophilia A without inhibitors against factor VIII (FVIII), are planned to be enrolled at sites across Italy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must own a device compatible with the electronic Patient-Reported Outcome (ePRO) application and with the fitness tracker that will be provided to the patient\n* Must have on his/her own device a data traffic availability of at least 2 gigabytes (GB) in total per month intended only for use of study applications and data transfer. If the data traffic plan is exhausted, the participant must be able to connect to a wi-fi network at least once every day in order to transfer the data collected for the study purpose\n* Must accept to run on his/her own device the ePRO application and the fitness tracker application\n* Must be available to turn on daily the bluetooth connection of his/her own device in order to allow the synchronization with the fitness tracker\n* Ability and willingness to comply with all aspects of the protocol, including completion of questions on the ePRO application (for underage population, ePRO questions can be answered by legally authorized representative if deemed necessary)\n* Ability and willingness to wear the activity tracking device as indicated\n* Diagnosis of severe (FVIII \\<1%) or moderate (FVIII ≥1% and ≤2%) congenital haemophilia A\n* No prior history of a positive inhibitor against FVIII. If participant has a previous history of inhibitor development, the participant must have successfully eradicated inhibitors since 3 years.\n* At least 150 exposure days of FVIII prior to enrolment\n\nExclusion Criteria:\n\n* Bleeding disorder other than congenital haemophilia A\n* Ongoing (or planned during the study) immune tolerance induction or FVIII prophylaxis if the participant has currently low titre of inhibitors or had inhibitors in the past 3 years\n* Previous or concomitant autoimmune or connective tissue disease\n* History of or suspected allergy or intolerance to any of the component of the fitness device (e.g., aluminium anodised)\n* History of clinically significant hypersensitivity associated with monoclonal antibody\n* Obesity (Body Mass Index \\[BMI\\] ≥30 kilograms/metre squared of body surface area \\[kg/m\\^2})\n* Clinically important cardiovascular, metabolic, endocrine disorders or any other concomitant diseases or conditions that could limit the mobility of participant or could represent any risk according to the Investigator's judgment, or that could interfere with the study evaluation parameters\n* Participation in any other interventional clinical trial, including Roche sponsored studies or in any other support program that may include drug administration other than standard clinical practice (e.g., compassionate use, use not in agreement with the authorized indications, patient support programs, etc.)"}, 'identificationModule': {'nctId': 'NCT04165135', 'acronym': 'POWER', 'briefTitle': 'An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Non-Interventional Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Patients With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment', 'orgStudyIdInfo': {'id': 'ML40983'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Haemophilia A Without FVIII Inhibitors', 'interventionNames': ['Drug: Standard of Care for Haemophilia A']}], 'interventions': [{'name': 'Standard of Care for Haemophilia A', 'type': 'DRUG', 'description': "There is no pre-determined studied medicinal product. Any treatment (including treatments started during the observational period) will be administered according to standard clinical practice, independently of participation in the current study, according to clinician's independent therapeutic decision.", 'armGroupLabels': ['Haemophilia A Without FVIII Inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'facility': 'AOU Cons. Policlinico Bari; Centro Emofilia e Trombosi - UO Medicina Trasfusionale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '88100', 'city': 'Catanzaro', 'state': 'Calabria', 'country': 'Italy', 'facility': 'Az. Osp. Pugliese Ciaccio; S. C. Emofilia, Emostasi e Trombosi', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'AOU Federico II; Medicina Clinica Chirurgia Centro Emocoaugulopatie e Emofilia', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '47521', 'city': 'Cesena', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'PO Cesena - Osp M. Bufalini; Patologia Clinica - S.S.A. Serv. Medicina Trasf.- Centro Emofilia', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}, {'zip': '00161', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': "Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesù; Oncoematologia Centro Emostasi e Trombosi', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Policlinico Univ. A. Gemelli; Polo di Scienze Oncologiche ed Ematologiche', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20122', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'IRCCS Ca\' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo; S.C. Medicina Generale 2 - Centro Emofilia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '15100', 'city': 'Alessandria', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'A.O.Santi Antonio e Biagio e Cesare Arrigo; S.S. Emostasi e Trombosi - Dip. Onco-Ema e Med Spec.', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'AO Città Salute e Scienza D-Osp S. G. Battista Molinette; SSCVD Malattie Tromboti e Emorragiche', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Osp. Infant. Regina Margherita; S.S.D. Medicina Trasfusionale Materno-infantile Traumatologica', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '90127', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Azienda Uni Ria Policlinico P. Giaccone ; Divisione Di Ematologia E Trapianto', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '95123', 'city': 'Via S. Sofia 78', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Ospedale Ferrarotto; Divisione Di Ematologia'}, {'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'AOU Careggi; SOD Malattie Emorragiche', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova; Centro Emofilia', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '36100', 'city': 'Vicenza', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Ospedale Di Vicenza; Nefrologia, Ematologia', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).\n\nFor further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}