Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
Study NCT ID:
NCT03943550
Status:
TERMINATED
Last Update Posted:
2024-02-15
First Post:
2019-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, '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': 'From baseline up to safety follow-up visit on Day 99', 'description': 'Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 23, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 17, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 49, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Injection related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}], 'seriousEvents': [{'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Number of participants with at least 1 AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Number of participants with at least one SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to safety follow-up visit on Day 99', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. Severity of AEs were graded according to NCI CTCAE v4.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of RO7049665', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Day 1-Day 15: Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '24.00'}, {'value': '24.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '72.08'}]}]}, {'title': 'Day 43: Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.06', 'groupId': 'OG000', 'lowerLimit': '12.00', 'upperLimit': '72.57'}, {'value': '24.00', 'groupId': 'OG001', 'lowerLimit': '12.00', 'upperLimit': '73.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 15 (predose) and Day 43 (post-dose)', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis population included participants who had received active treatment. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration Observed (Cmax) of RO7049665', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 7.5mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Day 1: Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '8.59', 'upperLimit': '63.7'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '250'}]}]}, {'title': 'Day 43: Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '65.4'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '109'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 43: Pre-dose, 6 h and 12 h post-dose', 'unitOfMeasure': 'nanograms per milliliters (ng/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis population included participants who had received active treatment. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUCinf) of RO7049665', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Day 1: Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2030', 'groupId': 'OG000', 'lowerLimit': '1020', 'upperLimit': '3550'}, {'value': '4520', 'groupId': 'OG001', 'lowerLimit': '1780', 'upperLimit': '15100'}]}]}, {'title': 'Day 43: Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3520', 'groupId': 'OG000', 'lowerLimit': '1830', 'upperLimit': '5740'}, {'value': '4110', 'groupId': 'OG001', 'lowerLimit': '2200', 'upperLimit': '8240'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 43: Pre-dose, 6 h and 12 h post-dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had received active treatment. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '2.59', 'spread': '0.50', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-0.54', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Flexible sigmoidoscopy (or colonoscopy) was centrally read and scored using the MCS-ES scoring systems. The disease was considered as endoscopic normal or inactive if the MCS-ES (centrally read) was 0, mild (erythema, decreased vascular pattern) if MCS-ES was 1, moderate (marked erythema, absent vascular pattern, erosions) if MCS-ES was 2 and severe (spontaneous bleeding, ulceration) if MCS-ES was 3. The Endoscopy Subscore of the Mayo Score was modified so that a value of 1 did not include friability. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.33', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '3.85', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '1.52', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '1.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Flexible sigmoidoscopy (or colonoscopy) were centrally read and scored using the UCEIS scoring systems. The UCEIS total score is a sum of 3 assessments: Bleeding (scored 0-3), Erosion and Ulcers (scored 0-3), and Vascular Pattern (scored 0-2). The total score ranges from 0-8, with higher score indicating more severe disease. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Geboes Score (GS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.56', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '1.92', 'groupId': 'OG001'}, {'value': '3.54', 'spread': '2.04', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.89', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '2.85', 'groupId': 'OG001'}, {'value': '-0.54', 'spread': '1.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 centimeters (cm) from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using GS. The GS is a stepwise grading system used for the evaluation of microscopic inflammation and histopathologic disease activity in UC. The microscopic appearance of the mucosa is categorized into 6 grades: Grade 0: architectural changes, Grade 1: chronic inflammatory infiltrate, Grade 2: lamina propria neutrophils and eosinophils, Grade 3: neutrophils in epithelium, Grade 4: crypt destruction and erosions or Grade 5: ulcerations, and each grade of the score is divided in 4 subcategories. A decrease of the Geboes grading system to Grades 0 or 1 would indicate mucosal healing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Robarts Histology Index (RHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.78', 'spread': '7.19', 'groupId': 'OG000'}, {'value': '11.44', 'spread': '9.30', 'groupId': 'OG001'}, {'value': '14.88', 'spread': '10.90', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.11', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '11.85', 'groupId': 'OG001'}, {'value': '-3.17', 'spread': '7.36', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.22', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '16.83', 'groupId': 'OG001'}, {'value': '-1.25', 'spread': '8.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using RIH. The RHI is an evaluative index, derived from the Geboes score and is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. The total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Nancy Histology Index (NHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '2.42', 'spread': '1.68', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '1.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '1.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using NHI. NHI is a validated index for assessing histological disease activity in UC. It is composed of three histological items defining five grades of disease activity: absence of significant histological disease (Grade 0), chronic inflammatory infiltrate with no acute inflammatory infiltrate (Grade 1), mildly active disease (Grade 2), moderately active disease (Grade 3), and severely active disease (Grade 4). The presence of ulceration on the biopsy specimen corresponds to severely active disease (Grade 4). A decrease of the NHI grading system to Grades 0 or 1 would indicate improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mayo Clinic Score (MCS) Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '48.25'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '7.49', 'upperLimit': '70.07'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '4.74', 'upperLimit': '37.38'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '2.81', 'upperLimit': '60.01'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '84.3'}, {'value': '45.8', 'groupId': 'OG002', 'lowerLimit': '25.55', 'upperLimit': '67.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'The MCS ranges from 0 to 12 and is a composite of 4 assessments: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Each assessment was rated from 0-3, with higher score indicating more severe disease. Clinical response was defined as a decrease in the MCS of at least 3 points and at least 30% decrease from baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'ADA Positive: Treatment-Induced ADA Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'ADA Positive: Treatment-Enhanced ADA Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; Post-dose on Days 8, 22, 57, 71 and 99; Pre-dose on Days 15, 29 and 43', 'description': 'ADA assays was used to detect anti-drug antibodies against RO7049665. Samples which were positive for anti-drug antibodies were further assessed using a neutralizing antibody assay. Participants were considered ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population included all participants who had at least one pre-dose and one post-dose ADA assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in White Blood Cells (Tregs, Teffs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'CD4 Treg: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.25', 'spread': '33.34', 'groupId': 'OG000'}, {'value': '42.14', 'spread': '25.07', 'groupId': 'OG001'}, {'value': '51.21', 'spread': '35.09', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.83', 'spread': '9.33', 'groupId': 'OG000'}, {'value': '-24.33', 'spread': '19.51', 'groupId': 'OG001'}, {'value': '-25.65', 'spread': '14.19', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.17', 'spread': '22.53', 'groupId': 'OG000'}, {'value': '61.80', 'spread': '31.22', 'groupId': 'OG001'}, {'value': '87.37', 'spread': '66.84', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': '15.32', 'groupId': 'OG000'}, {'value': '66.00', 'spread': '68.26', 'groupId': 'OG001'}, {'value': '169.34', 'spread': '138.21', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.25', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '27.20', 'spread': '18.99', 'groupId': 'OG001'}, {'value': '137.81', 'spread': '98.51', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 15 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.80', 'spread': '11.57', 'groupId': 'OG000'}, {'value': '16.29', 'spread': '28.42', 'groupId': 'OG001'}, {'value': '37.73', 'spread': '41.74', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.17', 'spread': '5.89', 'groupId': 'OG000'}, {'value': '76.00', 'spread': '70.04', 'groupId': 'OG001'}, {'value': '186.45', 'spread': '130.40', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 29 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '15.57', 'spread': '18.74', 'groupId': 'OG001'}, {'value': '27.66', 'spread': '29.09', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.57', 'spread': '11.92', 'groupId': 'OG000'}, {'value': '56.80', 'spread': '57.37', 'groupId': 'OG001'}, {'value': '110.61', 'spread': '72.94', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 43 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '13.32', 'groupId': 'OG000'}, {'value': '36.80', 'spread': '26.12', 'groupId': 'OG001'}, {'value': '33.22', 'spread': '53.39', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.71', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '74.50', 'spread': '48.63', 'groupId': 'OG001'}, {'value': '149.96', 'spread': '129.48', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '110.40', 'spread': '57.33', 'groupId': 'OG001'}, {'value': '115.79', 'spread': '149.90', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '7.50', 'groupId': 'OG000'}, {'value': '93.20', 'spread': '39.16', 'groupId': 'OG001'}, {'value': '81.64', 'spread': '83.51', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '44.00', 'spread': '28.47', 'groupId': 'OG001'}, {'value': '35.08', 'spread': '58.97', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Treg: Change from Baseline at Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.38', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '42.32', 'groupId': 'OG001'}, {'value': '14.50', 'spread': '45.04', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '513.11', 'spread': '249.55', 'groupId': 'OG000'}, {'value': '707.72', 'spread': '360.77', 'groupId': 'OG001'}, {'value': '678.04', 'spread': '211.81', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.36', 'spread': '166.81', 'groupId': 'OG000'}, {'value': '-164.07', 'spread': '178.26', 'groupId': 'OG001'}, {'value': '-191.79', 'spread': '175.75', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '130.75', 'spread': '183.96', 'groupId': 'OG000'}, {'value': '101.17', 'spread': '486.37', 'groupId': 'OG001'}, {'value': '13.23', 'spread': '161.24', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.50', 'spread': '152.39', 'groupId': 'OG000'}, {'value': '148.17', 'spread': '352.08', 'groupId': 'OG001'}, {'value': '232.48', 'spread': '237.40', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.08', 'spread': '271.08', 'groupId': 'OG000'}, {'value': '117.06', 'spread': '212.04', 'groupId': 'OG001'}, {'value': '328.00', 'spread': '375.95', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 15 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '145.07', 'spread': '226.10', 'groupId': 'OG000'}, {'value': '89.06', 'spread': '182.77', 'groupId': 'OG001'}, {'value': '24.48', 'spread': '234.22', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.25', 'spread': '140.67', 'groupId': 'OG000'}, {'value': '117.17', 'spread': '296.90', 'groupId': 'OG001'}, {'value': '237.22', 'spread': '284.96', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 29 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '189.20', 'groupId': 'OG000'}, {'value': '21.50', 'spread': '289.32', 'groupId': 'OG001'}, {'value': '-46.28', 'spread': '165.72', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.13', 'spread': '174.33', 'groupId': 'OG000'}, {'value': '-22.38', 'spread': '204.94', 'groupId': 'OG001'}, {'value': '154.17', 'spread': '198.56', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 43 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.50', 'spread': '174.27', 'groupId': 'OG000'}, {'value': '96.69', 'spread': '261.72', 'groupId': 'OG001'}, {'value': '72.65', 'spread': '193.91', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.88', 'spread': '166.61', 'groupId': 'OG000'}, {'value': '128.31', 'spread': '518.60', 'groupId': 'OG001'}, {'value': '182.40', 'spread': '287.99', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.63', 'spread': '210.91', 'groupId': 'OG000'}, {'value': '220.56', 'spread': '293.51', 'groupId': 'OG001'}, {'value': '226.19', 'spread': '274.34', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '117.60', 'spread': '160.56', 'groupId': 'OG000'}, {'value': '199.64', 'spread': '309.23', 'groupId': 'OG001'}, {'value': '302.03', 'spread': '282.02', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '154.15', 'groupId': 'OG000'}, {'value': '202.56', 'spread': '315.23', 'groupId': 'OG001'}, {'value': '28.70', 'spread': '194.94', 'groupId': 'OG002'}]}]}, {'title': 'CD4 Teff: Change from Baseline at Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80.89', 'spread': '138.90', 'groupId': 'OG000'}, {'value': '142.81', 'spread': '229.77', 'groupId': 'OG001'}, {'value': '-31.68', 'spread': '158.78', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '178.22', 'spread': '125.11', 'groupId': 'OG000'}, {'value': '282.78', 'spread': '226.36', 'groupId': 'OG001'}, {'value': '272.40', 'spread': '134.63', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.57', 'spread': '47.73', 'groupId': 'OG000'}, {'value': '-83.00', 'spread': '109.30', 'groupId': 'OG001'}, {'value': '-43.87', 'spread': '90.73', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.08', 'spread': '107.79', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '242.60', 'groupId': 'OG001'}, {'value': '-16.23', 'spread': '96.79', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.38', 'spread': '63.78', 'groupId': 'OG000'}, {'value': '12.89', 'spread': '159.82', 'groupId': 'OG001'}, {'value': '67.40', 'spread': '127.56', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.83', 'spread': '113.33', 'groupId': 'OG000'}, {'value': '41.78', 'spread': '125.23', 'groupId': 'OG001'}, {'value': '115.35', 'spread': '216.62', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 15 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.21', 'spread': '72.60', 'groupId': 'OG000'}, {'value': '-68.33', 'spread': '119.93', 'groupId': 'OG001'}, {'value': '8.00', 'spread': '105.56', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.25', 'spread': '64.06', 'groupId': 'OG000'}, {'value': '-23.89', 'spread': '247.21', 'groupId': 'OG001'}, {'value': '68.52', 'spread': '152.91', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 29 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.67', 'spread': '81.40', 'groupId': 'OG000'}, {'value': '-81.56', 'spread': '170.89', 'groupId': 'OG001'}, {'value': '-27.85', 'spread': '117.53', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.00', 'spread': '56.32', 'groupId': 'OG000'}, {'value': '-23.81', 'spread': '72.26', 'groupId': 'OG001'}, {'value': '94.21', 'spread': '121.77', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 43 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '58.42', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '100.23', 'groupId': 'OG001'}, {'value': '21.15', 'spread': '108.79', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.00', 'spread': '62.64', 'groupId': 'OG000'}, {'value': '26.44', 'spread': '213.36', 'groupId': 'OG001'}, {'value': '63.07', 'spread': '148.04', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.38', 'spread': '72.51', 'groupId': 'OG000'}, {'value': '49.06', 'spread': '153.58', 'groupId': 'OG001'}, {'value': '83.10', 'spread': '154.47', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.60', 'spread': '17.31', 'groupId': 'OG000'}, {'value': '41.79', 'spread': '143.04', 'groupId': 'OG001'}, {'value': '105.47', 'spread': '181.80', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-16.50', 'spread': '63.83', 'groupId': 'OG000'}, {'value': '52.81', 'spread': '200.84', 'groupId': 'OG001'}, {'value': '25.33', 'spread': '130.86', 'groupId': 'OG002'}]}]}, {'title': 'CD8 Teff: Change from Baseline at Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.89', 'spread': '64.96', 'groupId': 'OG000'}, {'value': '11.69', 'spread': '114.91', 'groupId': 'OG001'}, {'value': '21.82', 'spread': '122.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71', 'unitOfMeasure': 'cells/µl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in White Blood Cells (Natural Killer (NK) Cells)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '146.44', 'spread': '71.80', 'groupId': 'OG000'}, {'value': '154.00', 'spread': '102.99', 'groupId': 'OG001'}, {'value': '227.24', 'spread': '157.93', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.31', 'spread': '47.27', 'groupId': 'OG000'}, {'value': '13.22', 'spread': '59.30', 'groupId': 'OG001'}, {'value': '34.56', 'spread': '157.84', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.88', 'spread': '130.28', 'groupId': 'OG000'}, {'value': '56.67', 'spread': '114.71', 'groupId': 'OG001'}, {'value': '57.77', 'spread': '119.77', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.44', 'spread': '75.75', 'groupId': 'OG000'}, {'value': '105.67', 'spread': '72.36', 'groupId': 'OG001'}, {'value': '73.90', 'spread': '128.85', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.94', 'spread': '55.97', 'groupId': 'OG000'}, {'value': '77.33', 'spread': '125.77', 'groupId': 'OG001'}, {'value': '119.31', 'spread': '131.70', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 15 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '51.40', 'groupId': 'OG000'}, {'value': '20.89', 'spread': '45.83', 'groupId': 'OG001'}, {'value': '-25.35', 'spread': '85.97', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.19', 'spread': '40.55', 'groupId': 'OG000'}, {'value': '47.44', 'spread': '84.33', 'groupId': 'OG001'}, {'value': '93.81', 'spread': '167.15', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.78', 'spread': '136.64', 'groupId': 'OG000'}, {'value': '-39.00', 'spread': '52.92', 'groupId': 'OG001'}, {'value': '40.84', 'spread': '165.59', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.44', 'spread': '44.87', 'groupId': 'OG000'}, {'value': '28.44', 'spread': '32.84', 'groupId': 'OG001'}, {'value': '75.46', 'spread': '109.53', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 43 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '67.43', 'groupId': 'OG000'}, {'value': '-2.94', 'spread': '37.03', 'groupId': 'OG001'}, {'value': '-5.72', 'spread': '75.02', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.89', 'spread': '71.22', 'groupId': 'OG000'}, {'value': '72.19', 'spread': '33.30', 'groupId': 'OG001'}, {'value': '109.65', 'spread': '130.12', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.88', 'spread': '108.11', 'groupId': 'OG000'}, {'value': '46.19', 'spread': '65.72', 'groupId': 'OG001'}, {'value': '97.58', 'spread': '107.00', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.33', 'spread': '55.65', 'groupId': 'OG000'}, {'value': '56.31', 'spread': '60.30', 'groupId': 'OG001'}, {'value': '111.38', 'spread': '137.55', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.69', 'spread': '119.08', 'groupId': 'OG000'}, {'value': '50.69', 'spread': '74.56', 'groupId': 'OG001'}, {'value': '30.52', 'spread': '102.02', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.44', 'spread': '65.41', 'groupId': 'OG000'}, {'value': '49.94', 'spread': '39.55', 'groupId': 'OG001'}, {'value': '35.19', 'spread': '88.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71', 'unitOfMeasure': 'cells/µl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in White Blood Cells (B Cells)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '117.39', 'spread': '51.86', 'groupId': 'OG000'}, {'value': '149.39', 'spread': '75.67', 'groupId': 'OG001'}, {'value': '158.20', 'spread': '76.23', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.75', 'spread': '26.26', 'groupId': 'OG000'}, {'value': '-30.06', 'spread': '35.54', 'groupId': 'OG001'}, {'value': '-43.08', 'spread': '36.06', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.69', 'spread': '53.88', 'groupId': 'OG000'}, {'value': '27.94', 'spread': '115.62', 'groupId': 'OG001'}, {'value': '-41.87', 'spread': '47.32', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.31', 'spread': '31.10', 'groupId': 'OG000'}, {'value': '29.17', 'spread': '73.38', 'groupId': 'OG001'}, {'value': '14.50', 'spread': '39.33', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.75', 'spread': '24.33', 'groupId': 'OG000'}, {'value': '37.72', 'spread': '53.45', 'groupId': 'OG001'}, {'value': '48.83', 'spread': '48.94', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 15 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '34.11', 'groupId': 'OG000'}, {'value': '30.61', 'spread': '59.27', 'groupId': 'OG001'}, {'value': '17.24', 'spread': '46.26', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.31', 'spread': '28.01', 'groupId': 'OG000'}, {'value': '18.06', 'spread': '51.74', 'groupId': 'OG001'}, {'value': '25.65', 'spread': '52.69', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.28', 'spread': '35.09', 'groupId': 'OG000'}, {'value': '-5.06', 'spread': '38.13', 'groupId': 'OG001'}, {'value': '-7.02', 'spread': '33.59', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '28.83', 'groupId': 'OG000'}, {'value': '17.50', 'spread': '69.03', 'groupId': 'OG001'}, {'value': '22.52', 'spread': '39.02', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 43 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.25', 'spread': '51.24', 'groupId': 'OG000'}, {'value': '23.13', 'spread': '55.97', 'groupId': 'OG001'}, {'value': '23.54', 'spread': '47.44', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '25.68', 'groupId': 'OG000'}, {'value': '22.88', 'spread': '47.57', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '40.30', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.81', 'spread': '37.53', 'groupId': 'OG000'}, {'value': '28.00', 'spread': '53.38', 'groupId': 'OG001'}, {'value': '35.19', 'spread': '62.64', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.28', 'spread': '31.15', 'groupId': 'OG000'}, {'value': '20.63', 'spread': '58.57', 'groupId': 'OG001'}, {'value': '59.60', 'spread': '53.87', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-26.88', 'spread': '23.22', 'groupId': 'OG000'}, {'value': '24.13', 'spread': '56.16', 'groupId': 'OG001'}, {'value': '10.04', 'spread': '60.22', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.72', 'spread': '16.36', 'groupId': 'OG000'}, {'value': '4.38', 'spread': '66.38', 'groupId': 'OG001'}, {'value': '8.05', 'spread': '52.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71', 'unitOfMeasure': 'cells/µl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with evaluable data at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'OG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.177', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '0.233', 'spread': '0.275', 'groupId': 'OG001'}, {'value': '0.204', 'spread': '0.129', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.014', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '0.047', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '0.047', 'spread': '0.081', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.009', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '0.213', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.387', 'spread': '0.207', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 15 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '0.080', 'spread': '0.170', 'groupId': 'OG001'}, {'value': '0.283', 'spread': '0.486', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.286', 'spread': '0.214', 'groupId': 'OG001'}, {'value': '1.373', 'spread': '1.613', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 29 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.197', 'groupId': 'OG000'}, {'value': '0.041', 'spread': '0.199', 'groupId': 'OG001'}, {'value': '0.318', 'spread': '0.408', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.490', 'spread': '0.340', 'groupId': 'OG001'}, {'value': '1.234', 'spread': '0.837', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 43 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.194', 'spread': '0.210', 'groupId': 'OG001'}, {'value': '0.386', 'spread': '0.558', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '0.203', 'spread': '0.232', 'groupId': 'OG001'}, {'value': '0.378', 'spread': '0.599', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.031', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.155', 'groupId': 'OG001'}, {'value': '0.085', 'spread': '0.224', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.139', 'spread': '0.286', 'groupId': 'OG001'}, {'value': '-0.019', 'spread': '0.166', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 8, 22, 36, 57, 71 and follow-up visit on Day 99', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with evaluable data at specified timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as subcutaneous (SC) injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'FG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 milligrams (mg) as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'FG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant Moved Out of the Country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in this study at 4 investigative centers in 4 countries Georgia, Hungary, Moldova, Ukraine from 13 May 2019 to 22 July 2021.', 'preAssignmentDetails': 'Participants with active ulcerative colitis (UC) were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received RO7049665 matching placebo, as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'BG001', 'title': 'RO7049665 3.5 mg', 'description': 'Participants received RO7049665, 3.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'BG002', 'title': 'RO7049665 7.5 mg', 'description': 'Participants received RO7049665, 7.5 mg as SC injection, every 2 weeks for 4 doses up to Day 43 of the treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '35.1', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '43.3', 'spread': '13.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-20', 'size': 1096185, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-21T11:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'The decision to terminate study WP40161 was based on that treatment with RO7049665 showed trends in efficacy, however these data were below expectations and would not have supported superiority over standard of care.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2019-05-07', 'resultsFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-22', 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From baseline up to safety follow-up visit on Day 99', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. Severity of AEs were graded according to NCI CTCAE v4.0.'}], 'secondaryOutcomes': [{'measure': 'Time to Maximum Concentration (Tmax) of RO7049665', 'timeFrame': 'Day 1 to Day 15 (predose) and Day 43 (post-dose)'}, {'measure': 'Maximum Serum Concentration Observed (Cmax) of RO7049665', 'timeFrame': 'Days 1 and 43: Pre-dose, 6 h and 12 h post-dose'}, {'measure': 'Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUCinf) of RO7049665', 'timeFrame': 'Days 1 and 43: Pre-dose, 6 h and 12 h post-dose'}, {'measure': 'Change From Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES)', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Flexible sigmoidoscopy (or colonoscopy) was centrally read and scored using the MCS-ES scoring systems. The disease was considered as endoscopic normal or inactive if the MCS-ES (centrally read) was 0, mild (erythema, decreased vascular pattern) if MCS-ES was 1, moderate (marked erythema, absent vascular pattern, erosions) if MCS-ES was 2 and severe (spontaneous bleeding, ulceration) if MCS-ES was 3. The Endoscopy Subscore of the Mayo Score was modified so that a value of 1 did not include friability. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Flexible sigmoidoscopy (or colonoscopy) were centrally read and scored using the UCEIS scoring systems. The UCEIS total score is a sum of 3 assessments: Bleeding (scored 0-3), Erosion and Ulcers (scored 0-3), and Vascular Pattern (scored 0-2). The total score ranges from 0-8, with higher score indicating more severe disease. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Geboes Score (GS)', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 centimeters (cm) from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using GS. The GS is a stepwise grading system used for the evaluation of microscopic inflammation and histopathologic disease activity in UC. The microscopic appearance of the mucosa is categorized into 6 grades: Grade 0: architectural changes, Grade 1: chronic inflammatory infiltrate, Grade 2: lamina propria neutrophils and eosinophils, Grade 3: neutrophils in epithelium, Grade 4: crypt destruction and erosions or Grade 5: ulcerations, and each grade of the score is divided in 4 subcategories. A decrease of the Geboes grading system to Grades 0 or 1 would indicate mucosal healing.'}, {'measure': 'Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Robarts Histology Index (RHI)', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using RIH. The RHI is an evaluative index, derived from the Geboes score and is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. The total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Nancy Histology Index (NHI)', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using NHI. NHI is a validated index for assessing histological disease activity in UC. It is composed of three histological items defining five grades of disease activity: absence of significant histological disease (Grade 0), chronic inflammatory infiltrate with no acute inflammatory infiltrate (Grade 1), mildly active disease (Grade 2), moderately active disease (Grade 3), and severely active disease (Grade 4). The presence of ulceration on the biopsy specimen corresponds to severely active disease (Grade 4). A decrease of the NHI grading system to Grades 0 or 1 would indicate improvement.'}, {'measure': 'Percentage of Participants With Mayo Clinic Score (MCS) Clinical Response', 'timeFrame': 'Baseline, Days 29 and 57', 'description': 'The MCS ranges from 0 to 12 and is a composite of 4 assessments: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Each assessment was rated from 0-3, with higher score indicating more severe disease. Clinical response was defined as a decrease in the MCS of at least 3 points and at least 30% decrease from baseline.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Baseline; Post-dose on Days 8, 22, 57, 71 and 99; Pre-dose on Days 15, 29 and 43', 'description': 'ADA assays was used to detect anti-drug antibodies against RO7049665. Samples which were positive for anti-drug antibodies were further assessed using a neutralizing antibody assay. Participants were considered ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).'}, {'measure': 'Change From Baseline in White Blood Cells (Tregs, Teffs)', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71'}, {'measure': 'Change From Baseline in White Blood Cells (Natural Killer (NK) Cells)', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71'}, {'measure': 'Change From Baseline in White Blood Cells (B Cells)', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71'}, {'measure': 'Change From Baseline in Eosinophils', 'timeFrame': 'Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 8, 22, 36, 57, 71 and follow-up visit on Day 99'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis (UC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with UC for at least 12 weeks prior to screening\n* Screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years\n* Evidence of disease activity at time of screening\n* Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's disease or indeterminate colitis\n* History of infection with hepatitis B, human immunodeficiency virus (HIV), active hepatitis C virus (HCV) infection, or other chronic infection\n* Active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before Day -1\n* History of primary or acquired immunodeficiency\n* Abnormal hematologic values\n* Abnormal hepatic enzyme or hepatic function values"}, 'identificationModule': {'nctId': 'NCT03943550', 'briefTitle': 'Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'WP40161'}, 'secondaryIdInfos': [{'id': '2017-004599-74', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RO7049665', 'description': 'Participants will receive a subcutaneous (SC) dose of RO7049665 every 2 weeks for 4 doses.', 'interventionNames': ['Drug: RO7049665']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a SC dose of matching placebo every 2 weeks for 4 doses.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RO7049665', 'type': 'DRUG', 'description': 'Multiple ascending doses of RO7049665 will be administered SC.', 'armGroupLabels': ['RO7049665']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'The Research Institute of Clinical Medicine', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Drug Research Centre Gyogyszervizsgalo Kozpontot Kft.', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'SE ÁOK I. sz. Belgyógyászati Klinika', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'MD-2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '08112', 'city': 'Kapitanovka Village', 'state': 'KIEV Governorate', 'country': 'Ukraine', 'facility': 'Medical center of Yuriy Spizhenko LLC'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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'}}}}