Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-26 @ 7:00 AM
Study NCT ID:
NCT02570750
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 1 year', 'description': 'Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.", 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 4, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.", 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 4, 'seriousNumAtRisk': 68, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Erytrodermic psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Increase of serum transaminases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}], 'seriousEvents': [{'term': 'Inflammation at site injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Cerebellar haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Erytrodermic psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '16.5', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all treated participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '12.3', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '16.4', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': "The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all treated participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all treated participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}, {'value': '82.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '98.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all treated participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all treated participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'OG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.2', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '7.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '12.2', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '5.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '17.1', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '4.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index \\>30 kilogram per meter square were said to be obese in this outcome measure.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all treated participants. Here, "N" (overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per summary of product characteristics (SmPC), were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'FG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Inclusion/exclusion criteria deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept: Non Smokers', 'description': "Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'BG001', 'title': 'Etanercept: Smokers', 'description': "Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Per protocol set included all treated participants.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2015-10-05', 'resultsFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-04', 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline, Week 12, 24', 'description': "The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants."}, {'measure': 'Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24', 'timeFrame': 'Week 12, 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.'}, {'measure': 'Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24', 'timeFrame': 'Week 12, 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.'}, {'measure': 'Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12', 'timeFrame': 'Week 12', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).'}, {'measure': 'Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \\[h\\], arms \\[u\\], trunk \\[t\\], legs \\[l\\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\\*area score\\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index \\>30 kilogram per meter square were said to be obese in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Plaque Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801392&StudyName=Non-interventional%20Study%20Of%20The%20Effect%20Of%20Smoking%20Status%20Of%20The%20Patient%20On%20The%20Success%20Of%20Etanercept%20Therapy%20In%20Psoriasis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.', 'detailedDescription': 'Study hypothesis was based on the following rationale:\n\n* Psoriasis vulgaris is a chronic inflammatory skin disease with several extracutaneous manifestations and significant comorbidities (among others cardiovascular disease, metabolic syndrome, obesity and depression).\n* An increased prevalence of smoking among psoriasis patients, as compared with healthy subjects, has been observed in several studies\n* More recent studies suggest that cigarette smoking may trigger the development of psoriasis through oxidative, inflammatory and genetic mechanisms.Furthermore, smoking is associated with the clinical severity of psoriasis\n* Smoking also contributes to higher morbidity and mortality from smoking related disorders in these patients There is now some evidence that patients with psoriasis who smoke tend to be less responsive to treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged ≥18 years at the time of screening\n* Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator\n* Patients who are scheduled by their dermatologist to initiate treatment with Etanercept prescribed independently by the investigator as per local clinical practice guideline\n* Stable plaque psoriasis for at least 2 months prior to Baseline\n* Diagnosis of severe psoriasis defined as PASI \\> 10\n* Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC)\n* Smokers with smoking \\>10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2)\n* Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study\n\nExclusion Criteria:\n\n* Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab.\n* Exclusion Criteria according to the Enbrel® SmPC, with particular attention to: hypersensitivity to the active substance (etanercept) or to any of the excipients; sepsis or risk of sepsis, active infections, including chronic or localised infections.\n* Positive pregnancy test, breast feeding or considering becoming pregnant during the study\n* Clinically significant drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT02570750', 'briefTitle': 'The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis', 'orgStudyIdInfo': {'id': 'B1801392'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: smokers patients group', 'description': 'smokers (more than 10 cigarettes per day)', 'interventionNames': ['Behavioral: QUESTIONNAIRE ON SMOKING HABITS']}, {'label': 'Group 2 : non-smokers patients group', 'description': 'Smoking status will be classified as current and never/former. Former smokers will be defined as those who had stopped smoking at least 1 year before being interviewed for this study', 'interventionNames': ['Behavioral: QUESTIONNAIRE ON SMOKING HABITS']}], 'interventions': [{'name': 'QUESTIONNAIRE ON SMOKING HABITS', 'type': 'BEHAVIORAL', 'description': 'Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis).\n\nSmoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points.', 'armGroupLabels': ['Group 1: smokers patients group', 'Group 2 : non-smokers patients group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110121', 'city': 'Piteşti', 'state': 'Argeş', 'country': 'Romania', 'facility': 'Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'zip': '110283', 'city': 'Piteşti', 'state': 'Argeş', 'country': 'Romania', 'facility': 'County Emergency Hospital Pitesti / Dermatology Department', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'zip': '400001', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'SCBI Ambulatory Cluj-Napoca / Dermatology Department', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '400105', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Dr. Remus Orasan Medical Office', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '200061', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Dr Ianosi Medical Center Craiova / Dermatology Department', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '200642', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Emergency County Hospital Craiova / Dermatology Department', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '200642', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Helios Medica Ambulatory Craiova / Dermatology Department', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '130086', 'city': 'Târgovişte', 'state': 'Dâmbovița County', 'country': 'Romania', 'facility': 'County Hospital Targoviste / Dermatology Department', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'zip': '430341', 'city': 'Baia Mare', 'state': 'Maramureş', 'country': 'Romania', 'facility': 'Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'zip': '220097', 'city': 'Drobeta-Turnu Severin', 'state': 'Mehedinți County', 'country': 'Romania', 'facility': 'County Emergency Hospital Drobeta Turnu Severin / Dermatology Department', 'geoPoint': {'lat': 44.62693, 'lon': 22.65288}}, {'zip': '545300', 'city': 'Reghin', 'state': 'Mureș County', 'country': 'Romania', 'facility': 'Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin', 'geoPoint': {'lat': 46.7742, 'lon': 24.70216}}, {'zip': '545400', 'city': 'Sighișoara', 'state': 'Mureș County', 'country': 'Romania', 'facility': 'Sighisoara Municipal Hospital / Dermatology Department', 'geoPoint': {'lat': 46.22141, 'lon': 24.79279}}, {'zip': '540342', 'city': 'Târgu Mureş', 'state': 'Mureș County', 'country': 'Romania', 'facility': 'Mures County Clinical Hospital / Dermatology Department', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '100184', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'County Emergency Hospital Ploiesti / Dermatology Department', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '100576', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'County Emergency Hospital Ploiesti / Dermatology Department', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '450123', 'city': 'Zalău', 'state': 'Sălaj County', 'country': 'Romania', 'facility': 'County Emergency Hospital Zalau / Dermatology Department', 'geoPoint': {'lat': 47.2, 'lon': 23.05}}, {'zip': '300077', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'Municipal Emergency Hospital Timisoara / Dermatology Department', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '620034', 'city': 'Focşani', 'state': 'Vrancea', 'country': 'Romania', 'facility': 'County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department', 'geoPoint': {'lat': 45.7, 'lon': 27.18333}}, {'zip': '310112', 'city': 'Arad', 'country': 'Romania', 'facility': 'Stoica Dan Marius Dermatology Office Arad', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'zip': '600114', 'city': 'Bacau', 'country': 'Romania', 'facility': 'Emergency Hospital Bacau / Dermatology Department', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'zip': '710211', 'city': 'Botoșani', 'country': 'Romania', 'facility': 'County Emergency Hospital "Mavromati" Botosani / Dermatology Department', 'geoPoint': {'lat': 47.75, 'lon': 26.66667}}, {'zip': '500326', 'city': 'Brasov', 'country': 'Romania', 'facility': 'County Emergency Hospital Brasov / Dermatology Department', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '010825', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '011461', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Elias Emergency University Hospital Bucharest / Dermatology Department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '011464', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '020125', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Clinical Hospital Colentina Bucharest / Dermatology Department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030303', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Hospital "Dr. Victor Babes" Bucharest / Dermatology Department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700106', 'city': 'Iași', 'country': 'Romania', 'facility': 'County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '700506', 'city': 'Iași', 'country': 'Romania', 'facility': 'Railways Hospital Iasi / Dermatology Department', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '720019', 'city': 'Suceava', 'country': 'Romania', 'facility': 'Bucovina Medical Office Suceava', 'geoPoint': {'lat': 47.63333, 'lon': 26.25}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}