Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 8:34 PM
Study NCT ID:
NCT03369704
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months.', 'description': 'Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'IGE025', 'description': 'Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 26, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 21, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Testicular neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Nasal Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.66', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '0.144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '-0.62', 'pValueComment': 'H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.\n\nH1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.209', 'estimateComment': 'nasal symptom score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24March2018)', 'description': 'Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point).\n\nSevere symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Mean ocular symptom score', 'categories': [{'measurements': [{'value': '2.45', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '0.110', 'groupId': 'OG001'}]}]}, {'title': 'Mean nasal ocular symptom score', 'categories': [{'measurements': [{'value': '6.11', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '8.01', 'spread': '0.228', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '-1.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.331', 'estimateComment': 'Nasal Ocular Symptom', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '-0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'estimateComment': 'Ocular symptom', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point).\n\nNasal ocular symptom score consisted of nasal symptom score and ocular symptom score.\n\nNasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Mean nasal symptom medication score', 'categories': [{'measurements': [{'value': '6.19', 'spread': '0.166', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '0.158', 'groupId': 'OG001'}]}]}, {'title': 'Mean ocular symptom medication score', 'categories': [{'measurements': [{'value': '3.91', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '4.86', 'spread': '0.130', 'groupId': 'OG001'}]}]}, {'title': 'Mean nasal ocular symptom medication score', 'categories': [{'measurements': [{'value': '9.10', 'spread': '0.271', 'groupId': 'OG000'}, {'value': '11.15', 'spread': '0.259', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.229', 'estimateComment': 'nasal symptom medication score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'estimateComment': 'ocular symptom medication score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.05', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '-1.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.375', 'estimateComment': 'nasal ocular symptom medication score', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period.\n\nNasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride).', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Mean sneezing score', 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.050', 'groupId': 'OG001'}]}]}, {'title': 'Mean rhinorrhea score', 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.060', 'groupId': 'OG001'}]}]}, {'title': 'Mean nasal congestion score', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.056', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.073', 'estimateComment': 'sneezing score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.088', 'estimateComment': 'rhinorrhea score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.081', 'estimateComment': 'nasal congestion score', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Mean Score for Severity of Itchy and Watery Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Mean itchy eye score', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.058', 'groupId': 'OG001'}]}]}, {'title': 'Mean watery eye score', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.060', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.084', 'estimateComment': 'itchy eye score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'estimateComment': 'watery eye score', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Mean Score for Impairment of Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.050', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.072', 'estimateComment': 'score for impairment of daily activities', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Number of Symptom Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Nasal symptom free days', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'Ocular symptom free days', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '1.0', 'ciUpperLimit': '5.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'estimateComment': 'Nasal symptom free days', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '2.0', 'ciUpperLimit': '6.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'estimateComment': 'Ocular symptom free days', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24March2018)', 'description': 'Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Completely Nasal Symptom Free Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.43', 'ciLowerLimit': '1.21', 'ciUpperLimit': '9.75', 'estimateComment': 'Completely nasal symptom free patients', 'statisticalMethod': 'logistic regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Nasal rescue medication score', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.023', 'groupId': 'OG001'}]}]}, {'title': 'Ocular rescue medication score', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': 'Nasal ocular rescue medication score', 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.043', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'estimateComment': 'Nasal rescue mediation score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.040', 'estimateComment': 'Ocular rescue medication score', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.063', 'estimateComment': 'Nasal ocular rescue medication score', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point).\n\nRescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Nasal rescue medication free days', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'Ocular rescue medication free days', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'Nasal ocular rescue medication free days', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.0', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.89', 'estimateComment': 'Nasal rescue mediation free days', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '4.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.21', 'estimateComment': 'Ocular rescue medication free days', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.0', 'ciUpperLimit': '4.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'estimateComment': 'Nasal ocular rescue medication free days', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride).\n\nNasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Number of Rescue Medication Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Number of rescue nasal medication used', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '120'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '109'}]}]}, {'title': 'Number of ocular rescue medication used', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '109'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '113'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'estimateComment': 'Nasal rescue mediation used', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '-1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.81', 'estimateComment': 'Ocular rescue medication used', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Amount number of rescue medication used (a total number of times used).', 'unitOfMeasure': 'Number of times used', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.'}, {'type': 'SECONDARY', 'title': 'Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Nasal and eye symptoms (JRQLQ I)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.059', 'groupId': 'OG001'}]}]}, {'title': 'Mean score of QoL-related questionnaire (JRQLQ II)', 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'Overall face scale (JRQLQ III)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.086', 'estimateComment': 'JRQLQ I', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '-0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.093', 'estimateComment': 'JRQLQ II', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ANCOVA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'JRQLQ III', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient', 'description': 'Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-omalizumab Antibodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Anti-Fab-(pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fab (post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fc-(pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Fc-(post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch', 'description': 'Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set (SAF): The SAF consisted of all patients who received at least 1 dose of study drug. Patients in the SAF were analyzed according to treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Serum Trough Omalizumab Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.6', 'spread': '34.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.1', 'spread': '42.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.3', 'spread': '49.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 225/239', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.928', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose', 'description': 'Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Free IgE and Total IgE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'classes': [{'title': 'Free IgE (Day 1 predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG001'}]}]}, {'title': 'Free IgE (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG001'}]}]}, {'title': 'Free IgE (Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG001'}]}]}, {'title': 'Free IgE (Day 85)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '11.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG001'}]}]}, {'title': 'Free IgE (Day 225/239)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA= Not Available. A result is NA when \\> 1/3 of the values were above ULOQ (upper limit of quantification).\n\nULOQ defined as 150 ng/mL for free IgE', 'groupId': 'OG001'}]}]}, {'title': 'Total IgE (Day 1 pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '524', 'spread': '531', 'groupId': 'OG000'}, {'value': '570', 'spread': '641', 'groupId': 'OG001'}]}]}, {'title': 'Total IgE (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2040', 'spread': '1620', 'groupId': 'OG000'}, {'value': '558', 'spread': '608', 'groupId': 'OG001'}]}]}, {'title': 'Total IgE (Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2160', 'spread': '1660', 'groupId': 'OG000'}, {'value': '640', 'spread': '721', 'groupId': 'OG001'}]}]}, {'title': 'Total IgE (Day 85)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1960', 'spread': '1480', 'groupId': 'OG000'}, {'value': '673', 'spread': '775', 'groupId': 'OG001'}]}]}, {'title': 'Total IgE (Day 225/239)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '702', 'spread': '639', 'groupId': 'OG000'}, {'value': '669', 'spread': '783', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose', 'description': 'Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}], 'periods': [{'title': 'Treatment Epoch', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Epoch', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 22 centers in Kanto-area of Japan.', 'preAssignmentDetails': '337 patients were randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omalizumab', 'description': 'Omalizumab administered subcutaneously for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 15 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '15 <=, < 65 years', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized set (RAN): The RAN included all randomized patients, regardless of whether they received any study drug. Patients in the RAN was analyzed according to the treatment assigned at randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-19', 'size': 624154, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-05T13:43', 'hasProtocol': False}, {'date': '2017-06-07', 'size': 830671, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-05T13:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2017-11-14', 'resultsFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-14', 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Nasal Symptom Score', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24March2018)', 'description': 'Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point).\n\nSevere symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum.'}], 'secondaryOutcomes': [{'measure': 'Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point).\n\nNasal ocular symptom score consisted of nasal symptom score and ocular symptom score.\n\nNasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome.'}, {'measure': 'Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period.\n\nNasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride).'}, {'measure': 'Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).'}, {'measure': 'Mean Score for Severity of Itchy and Watery Eye', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).'}, {'measure': 'Mean Score for Impairment of Daily Activities', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).'}, {'measure': 'Number of Symptom Free Days', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24March2018)', 'description': 'Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.'}, {'measure': 'Completely Nasal Symptom Free Patients', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.'}, {'measure': 'Rescue Medication Score', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point).\n\nRescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid'}, {'measure': 'Rescue Medication Free Days', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride).\n\nNasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication).'}, {'measure': 'Number of Rescue Medication Used', 'timeFrame': 'Severe symptom period (from 23Feb2018 to 24Mar2018)', 'description': 'Amount number of rescue medication used (a total number of times used).'}, {'measure': 'Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score', 'timeFrame': 'Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient', 'description': 'Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.'}, {'measure': 'Number of Participants With Anti-omalizumab Antibodes', 'timeFrame': 'Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch', 'description': 'Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.'}, {'measure': 'Serum Trough Omalizumab Concentration', 'timeFrame': 'Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose', 'description': 'Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch'}, {'measure': 'Free IgE and Total IgE', 'timeFrame': 'Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose', 'description': 'Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryptomeria, omalizumab, seasonal allergic rhinitis'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=429', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to demonstrate the efficacy and safety of omalizumab compared with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids plus one or more medications out of anti-histamine, leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist) in the previous 2 Japanese cedar pollen seasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* A clinical history of Japanese cedar pollinosis defined by the following\n\n * Took nasal corticosteroid plus one or more medications out of antihistamine (second generation), leukotriene receptor antagonist, or prostaglandin D2 thromboxane A2 receptor antagonist in Japanese cedar pollen seasons in 2016 and 2017.\n * Had inadequately controlled symptoms of Japanese cedar pollinosis lasting at least one week in the Japanese cedar pollen season in 2017 despite the nasal corticosteroid plus one or more medications out of anti-histamine (second generation), leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist (regardless of having perennial allergic rhinitis or not)\n* Serum cedar pollen-specific Immunoglobulin E (IgE) levels of ≥ score of 3 by CAP/RAST-FEIA, ImmunoCAP or MAST at the screening epoch.\n* Developing a symptom of Japanese cedar pollinosis during the period from first observational day in cedar pollen in Kanto area to initial drug administration (Visit 101), as defined by the following\n\n * Having any nasal or ocular symptom (≥ score of 1 in sneezing, rhinorrhea, nasal congestion, itchy eye or watery eye) in at least 2 days or\n * Having both any nasal symptom (≥ score of 1 in sneezing, rhinorrhea, nasal congestion) and any eye symptom (≥ score of 1 in itchy eye or watery eye) in at least one day, which is confirmed by patient e-diary (unless a symptom is clearly consider to take place due to other than Japanese cedar pollinosis/allergic rhinitis (e.g., upper respiratory tract infection, or common cold)).\n* Body weight and serum total IgE level at screen epoch within the dosing table range; body weight of ≥ 20 to ≤ 150 kg and serum total IgE levels of ≥ 30 to ≤ 1500 IU/mL at a maximum.\n\nExclusion Criteria:\n\n* With an active rhinitis other than allergic rhinitis (e.g acute or chronic rhinitis, idiopathic rhinitis).\n* With an active nose disease other than allergic rhinitis (e.g., acute or chronic rhinosinusitis or deflected septum) which is expected to affect the evaluation of efficacy of the study drug judged by the investigator.\n* With elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or clinical allergic bronchopulmonary aspergillosis).\n* With a severe asthma treated with high dose inhaled corticosteroid (≥ 800 μg/day fluticasone propionate or an equivalent for aged ≥ 16 to \\<75 years, \\> 200 μg/day for aged ≥ 12 to \\<16 years).\n* Who are receiving operative treatment for allergic rhinitis (e.g., electrocoagulation, laser surgery, 80% trichloroacetic acid chemo-surgery, inferior turbinectomy or posterior nasal neurectomy) within 1 years prior to the screening epoch.'}, 'identificationModule': {'nctId': 'NCT03369704', 'briefTitle': 'Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled Severe Japanese Cedar Pollinosis Despite the Current Recommended Therapies', 'orgStudyIdInfo': {'id': 'CIGE025F1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omalizumab', 'description': 'Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks', 'interventionNames': ['Drug: Omalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Eligible patients randomized to this arm received placebo subcutaneously for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Omalizumab', 'type': 'DRUG', 'description': 'Omalizumab were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.', 'armGroupLabels': ['Omalizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '262-0015', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '272-0143', 'city': 'Ichikawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'zip': '2270082', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '270-0034', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '2710077', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '279-0012', 'city': 'Urayasu', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}, {'zip': '212-0027', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '216 0006', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '216-0002', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '343-0031', 'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'zip': '116 0011', 'city': 'Arakawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '101-0063', 'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '103 0027', 'city': 'Chuo Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '132-0014', 'city': 'Edogawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '125-0061', 'city': 'Katsushika-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.73333, 'lon': 139.85}}, {'zip': '164-0012', 'city': 'Nakano-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '158-0097', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '160-0008', 'city': 'Shinjuku Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '160-0017', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '170-0005', 'city': 'Toshima-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}