Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT03580356
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2018-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. 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'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 307, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 321, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 320, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 306, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 325, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 307, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 321, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 320, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 306, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 325, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 307, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 321, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 320, 'numAffected': 11}, {'groupId': 'EG003', 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'EG002', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 321, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 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{'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 321, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '321', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.029', 'ciLowerLimit': '3.183', 'ciUpperLimit': '25.615', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.6646', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.926', 'ciLowerLimit': '0.650', 'ciUpperLimit': '1.319', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.508', 'ciLowerLimit': '4.058', 'ciUpperLimit': '32.638', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.1730', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.181', 'ciLowerLimit': '0.836', 'ciUpperLimit': '1.667', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. Data is presented as percentage of patients with a UAS7=0 score. No Statistical analysis was planned for adolescent group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults + Adolescents = Total'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.218', 'spread': '0.651', 'groupId': 'OG000'}, {'value': '-20.312', 'spread': '0.654', 'groupId': 'OG001'}, {'value': '-19.632', 'spread': '0.652', 'groupId': 'OG002'}, {'value': '-9.221', 'spread': '1.135', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.997', 'ciLowerLimit': '-12.554', 'ciUpperLimit': '-7.439', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.305', 'groupDescription': 'Treatment contrast in LS mean (change), Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '0.6735', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.414', 'ciLowerLimit': '-1.392', 'ciUpperLimit': '2.221', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.922', 'groupDescription': 'Treatment contrast in LS mean (change), Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.091', 'ciLowerLimit': '-13.664', 'ciUpperLimit': '-8.518', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.313', 'groupDescription': 'Treatment contrast in LS mean (change), Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '0.2305', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.680', 'ciLowerLimit': '-2.489', 'ciUpperLimit': '1.128', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.923', 'groupDescription': 'Treatment contrast in LS mean (change), Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized Adult subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.92', 'spread': '13.479', 'groupId': 'OG000'}, {'value': '-24.83', 'spread': '12.640', 'groupId': 'OG001'}, {'value': '-18.16', 'spread': '10.246', 'groupId': 'OG002'}, {'value': '-11.94', 'spread': '14.278', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized adolescent subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.632', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '-9.023', 'spread': '0.300', 'groupId': 'OG001'}, {'value': '-8.733', 'spread': '0.300', 'groupId': 'OG002'}, {'value': '-4.527', 'spread': '0.522', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.105', 'ciLowerLimit': '-5.281', 'ciUpperLimit': '-2.929', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.600', 'groupDescription': 'Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '0.5943', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.101', 'ciLowerLimit': '-0.727', 'ciUpperLimit': '0.928', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.422', 'groupDescription': 'Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.496', 'ciLowerLimit': '-5.678', 'ciUpperLimit': '-3.314', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.603', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)', 'nonInferiorityComment': 'Adults only'}, {'pValue': '0.2467', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.290', 'ciLowerLimit': '-1.120', 'ciUpperLimit': '0.540', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.423', 'groupDescription': 'Adults only', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.38', 'spread': '6.994', 'groupId': 'OG000'}, {'value': '-12.04', 'spread': '6.264', 'groupId': 'OG001'}, {'value': '-8.56', 'spread': '4.935', 'groupId': 'OG002'}, {'value': '-6.97', 'spread': '7.904', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adolescents'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.443', 'ciLowerLimit': '1.955', 'ciUpperLimit': '6.063', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.8524', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.838', 'ciLowerLimit': '0.602', 'ciUpperLimit': '1.167', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.542', 'ciLowerLimit': '2.577', 'ciUpperLimit': '8.004', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.2764', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.106', 'ciLowerLimit': '0.794', 'ciUpperLimit': '1.540', 'groupDescription': 'Adults only', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Assessed as percentage of subjects achieving DLQI = 0-1, which means No impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults + Adolescents = Total'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '8.668', 'spread': '0.241', 'groupId': 'OG000'}, {'value': '8.897', 'spread': '0.246', 'groupId': 'OG001'}, {'value': '8.427', 'spread': '0.237', 'groupId': 'OG002'}, {'value': '6.242', 'spread': '0.331', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.389', 'ciLowerLimit': '1.235', 'ciUpperLimit': '1.561', 'groupDescription': 'Adults only', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}, {'pValue': '0.2369', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.029', 'ciLowerLimit': '0.952', 'ciUpperLimit': '1.111', 'groupDescription': 'Adults only', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.425', 'ciLowerLimit': '1.268', 'ciUpperLimit': '1.603', 'groupDescription': 'Adults only', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}, {'pValue': '0.0830', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.056', 'ciLowerLimit': '0.978', 'ciUpperLimit': '1.140', 'groupDescription': 'Adults only', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '4.60', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '3.01', 'groupId': 'OG002'}, {'value': '9.2', 'spread': '4.92', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adolescents'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ligelizumab 72 mg - Adults', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG001', 'title': 'Ligelizumab 72 mg - Adolescents', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG002', 'title': 'Ligelizumab 120 mg - Adults', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG003', 'title': 'Ligelizumab 120 mg - Adolescents', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG004', 'title': 'Omalizumab 300 mg - Adults', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'FG005', 'title': 'Omalizumab 300 mg - Adolescents', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'FG006', 'title': 'Placebo - Ligelizumab 120mg - Adults', 'description': '2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48'}, {'id': 'FG007', 'title': 'Placebo - Ligelizumab 120mg - Adolescents', 'description': '2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '304'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '309'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '103'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'Randomized Set (RAN)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '304'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '309'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '103'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'Safety Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '304'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '306'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '307'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '103'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '303'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '307'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '103'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '259'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '263'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '82'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '21'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Misrandomized, no treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Post-treatment Follow Up Period', 'milestones': [{'type': 'STARTED', 'comment': 'Entered post-treatment follow up period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '275'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '265'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '89'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '256'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '259'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '82'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '1,078 participants enrolled in 27 countries at 185 sites.', 'preAssignmentDetails': 'There were 1,023 adult subjects and 55 adolescent subjects. Out of these 3 adults were mis-randomized and hence did not enter treatment period.\n\n901 adults and 52 adolescent subjects entered the post treatment follow-up period. The number entering post-treatment follow up is higher than the number completing treatment since this also included subjects who entered the follow up period after early treatment discontinuation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'BG000'}, {'value': '323', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '1078', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'BG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'BG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '948', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized Set'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '41.7', 'spread': '13.42', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '14.11', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '14.11', 'groupId': 'BG002'}, {'value': '42.9', 'spread': '13.01', 'groupId': 'BG003'}, {'value': '42.9', 'spread': '13.81', 'groupId': 'BG004'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '1.39', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '1.56', 'groupId': 'BG001'}, {'value': '15.9', 'spread': '1.17', 'groupId': 'BG002'}, {'value': '14.8', 'spread': '1.47', 'groupId': 'BG003'}, {'value': '15.0', 'spread': '1.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '743', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '280', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Adult White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '752', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'Adult Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Adult Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '215', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Adult Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Native Hawaiian or Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Adult Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Adolescents Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Adult Multi-racial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Multi-racial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Adult Race Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '1023', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Race Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.'}], 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-05', 'size': 2239342, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-14T11:08', 'hasProtocol': True}, {'date': '2022-07-01', 'size': 1198832, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-14T11:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patients, investigator staff and personnel performing the study assessments remained blinded to the identity of the treatment from the time of randomization until final database lock. The study drug was prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator was involved in any assessments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1078}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2021-08-24', 'completionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2018-06-26', 'resultsFirstSubmitDate': '2022-12-14', 'studyFirstSubmitQcDate': '2018-06-26', 'dispFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-26', 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement'}, {'measure': 'Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement'}], 'secondaryOutcomes': [{'measure': 'Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'timeFrame': 'Week 12', 'description': 'The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. Data is presented as percentage of patients with a UAS7=0 score. No Statistical analysis was planned for adolescent group.'}, {'measure': 'Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.'}, {'measure': 'Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'timeFrame': 'Week 12', 'description': 'Assessed as percentage of subjects achieving DLQI = 0-1, which means No impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.'}, {'measure': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.'}, {'measure': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-IgE', 'CSU', 'Chronic Spontaneous Urticaria', 'hives severity score', 'itch severity score', 'urticaria activity score'], 'conditions': ['Chronic Spontaneous Urticaria']}, 'referencesModule': {'references': [{'pmid': '38008109', 'type': 'DERIVED', 'citation': 'Maurer M, Ensina LF, Gimenez-Arnau AM, Sussman G, Hide M, Saini S, Grattan C, Fomina D, Rigopoulos D, Berard F, Canonica GW, Rockmann H, Irani C, Szepietowski JC, Leflein J, Bernstein JA, Peter JG, Kulthanan K, Godse K, Ardusso L, Ukhanova O, Staubach P, Sinclair R, Gogate S, Thomsen SF, Tanus T, Ye YM, Burciu A, Barve A, Modi D, Scosyrev E, Hua E, Letzelter K, Varanasi V, Patekar M, Severin T; PEARL-1 and PEARL-2 trial investigators. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet. 2024 Jan 13;403(10422):147-159. doi: 10.1016/S0140-6736(23)01684-7. Epub 2023 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.\n\nThe study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.\n\nThis was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.', 'detailedDescription': 'This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:\n\n* Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility.\n* Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks.\n* Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.\n* Male and female subjects ≥ 12 years of age at the time of screening.\n* CSU diagnosis for ≥ 6 months.\n* Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:\n* The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine\n* UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)\n* Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)\n* Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.\n\nKey Exclusion Criteria:\n\n* History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).\n* Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.\n* Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).\n* Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.\n* Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).\n* Prior exposure to ligelizumab or omalizumab.\n* H1-AH used as background medication at greater than locally label-approved doses after visit 1"}, 'identificationModule': {'nctId': 'NCT03580356', 'briefTitle': 'A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines', 'orgStudyIdInfo': {'id': 'CQGE031C2303'}, 'secondaryIdInfos': [{'id': '2018-000840-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w', 'interventionNames': ['Biological: Ligelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w', 'interventionNames': ['Biological: Ligelizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w', 'interventionNames': ['Biological: Omalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ligelizumab', 'type': 'BIOLOGICAL', 'description': 'Liquid in vial', 'armGroupLabels': ['Ligelizumab 120 mg', 'Ligelizumab 72 mg']}, {'name': 'Omalizumab', 'type': 'BIOLOGICAL', 'description': 'Lyophilized powder for solution in vial', 'armGroupLabels': ['Omalizumab 300 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Liquid in vial', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Allervie Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Resch of Arizona-Div of Allergy Asthma and Immunology', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72209', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Atria Clinical Research Asthma and Allergy Institute', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'DeMera Allergy Asthma and Immun Ctr', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Allergy and Asthma Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonathan Corren Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Consultants', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Associates of Santa Clara Vally Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Clinical Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83616', 'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Research', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Allergy Sinus Asthma SC', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institute for Asthma and Allergy PC', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '21162', 'city': 'White Marsh', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Clinical Research', 'geoPoint': {'lat': 39.38372, 'lon': -76.43218}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Clinical Research LcLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Medical Research', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68046', 'city': 'Papillion', 'state': 'Nebraska', 'country': 'United States', 'facility': 'The Asthma and Allergy Center PC', 'geoPoint': {'lat': 41.15444, 'lon': -96.04224}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School Of Med At Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Institute of Clinical Research', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Allergy Asthma and Clinical Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97015', 'city': 'Clackamas', 'state': 'Oregon', 'country': 'United States', 'facility': 'PCR DBA Columbia Asthma and Allergy', 'geoPoint': {'lat': 45.40762, 'lon': -122.57037}}, {'zip': '19422', 'city': 'Blue Bell', 'state': 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