Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 2:44 PM
Study NCT ID:
NCT01918033
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2013-08-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C121345', 'term': 'desloratadine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 weeks after last dose of study drug (up to 4 weeks)', 'description': 'The population consisted of all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks', 'otherNumAtRisk': 202, 'otherNumAffected': 11, 'seriousNumAtRisk': 202, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks', 'otherNumAtRisk': 203, 'otherNumAffected': 17, 'seriousNumAtRisk': 203, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks', 'otherNumAtRisk': 201, 'otherNumAffected': 9, 'seriousNumAtRisk': 201, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasphopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.96', 'spread': '2.21', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '-1.67'}, {'value': '-1.94', 'spread': '2.21', 'groupId': 'OG001', 'lowerLimit': '-2.23', 'upperLimit': '-1.65'}, {'value': '-1.87', 'spread': '2.34', 'groupId': 'OG002', 'lowerLimit': '-2.16', 'upperLimit': '-1.58'}]}]}], 'analyses': [{'pValue': '0.661', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.31', 'estimateComment': 'Difference in LS Means for Change from Baseline in TNSS at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.707', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.32', 'estimateComment': 'Difference in LS Means for Change from Baseline in TNSS at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 2', 'description': 'The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 4', 'description': 'An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 2', 'description': 'An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT population consisted of all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Change from Baseline (BL) at Day 3', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '2.05', 'groupId': 'OG000', 'lowerLimit': '-1.38', 'upperLimit': '-0.86'}, {'value': '-1.11', 'spread': '2.02', 'groupId': 'OG001', 'lowerLimit': '-1.37', 'upperLimit': '-0.85'}, {'value': '-0.63', 'spread': '2.03', 'groupId': 'OG002', 'lowerLimit': '-0.89', 'upperLimit': '-0.37'}]}]}, {'title': 'Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-1.39', 'spread': '2.41', 'groupId': 'OG000', 'lowerLimit': '-1.68', 'upperLimit': '-1.09'}, {'value': '-1.39', 'spread': '2.28', 'groupId': 'OG001', 'lowerLimit': '-1.69', 'upperLimit': '-1.10'}, {'value': '-1.48', 'spread': '2.32', 'groupId': 'OG002', 'lowerLimit': '-1.78', 'upperLimit': '-1.18'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '-0.11', 'estimateComment': 'Difference in LS Means for Change from Baseline in TNSS at Day 3', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.10', 'estimateComment': 'Difference in LS Means for Change from Baseline in TNSS at Day 3', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.569', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.53', 'estimateComment': 'Difference in LS Means for Change from Baseline in TNSS at Week 1', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.685', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.50', 'estimateComment': 'Difference in LS Means for Change from Baseline in TNSS at Week 1', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1', 'description': 'The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Sneezing: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.75', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '-0.13'}, {'value': '-0.29', 'spread': '0.67', 'groupId': 'OG001', 'lowerLimit': '-0.38', 'upperLimit': '-0.20'}, {'value': '-0.13', 'spread': '0.65', 'groupId': 'OG002', 'lowerLimit': '-0.21', 'upperLimit': '-0.04'}]}]}, {'title': 'Sneezing: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.78', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '-0.17'}, {'value': '-0.36', 'spread': '0.75', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '-0.27'}, {'value': '-0.38', 'spread': '0.76', 'groupId': 'OG002', 'lowerLimit': '-0.47', 'upperLimit': '-0.29'}]}]}, {'title': 'Sneezing: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.74', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '-0.35'}, {'value': '-0.51', 'spread': '0.69', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.42'}, {'value': '-0.40', 'spread': '0.73', 'groupId': 'OG002', 'lowerLimit': '-0.49', 'upperLimit': '-0.32'}]}]}, {'title': 'Rhinorrhea: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.66', 'groupId': 'OG000', 'lowerLimit': '-0.47', 'upperLimit': '-0.28'}, {'value': '-0.32', 'spread': '0.73', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '-0.22'}, {'value': '-0.24', 'spread': '0.74', 'groupId': 'OG002', 'lowerLimit': '-0.33', 'upperLimit': '-0.15'}]}]}, {'title': 'Rhinorrhea: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.77', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '-0.29'}, {'value': '-0.38', 'spread': '0.83', 'groupId': 'OG001', 'lowerLimit': '-0.48', 'upperLimit': '-0.28'}, {'value': '-0.44', 'spread': '0.78', 'groupId': 'OG002', 'lowerLimit': '-0.54', 'upperLimit': '-0.34'}]}]}, {'title': 'Rhinorrhea: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.73', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '-0.47'}, {'value': '-0.53', 'spread': '0.83', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '-0.43'}, {'value': '-0.56', 'spread': '0.83', 'groupId': 'OG002', 'lowerLimit': '-0.66', 'upperLimit': '-0.46'}]}]}, {'title': 'Nasal Congestion: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.68', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '-0.13'}, {'value': '-0.17', 'spread': '0.68', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '-0.09'}, {'value': '-0.13', 'spread': '0.65', 'groupId': 'OG002', 'lowerLimit': '-0.22', 'upperLimit': '-0.04'}]}]}, {'title': 'Nasal Congestion: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.81', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '-0.18'}, {'value': '-0.22', 'spread': '0.70', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '-0.13'}, {'value': '-0.32', 'spread': '0.73', 'groupId': 'OG002', 'lowerLimit': '-0.42', 'upperLimit': '-0.23'}]}]}, {'title': 'Nasal Congestion: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.78', 'groupId': 'OG000', 'lowerLimit': '-0.43', 'upperLimit': '-0.23'}, {'value': '-0.33', 'spread': '0.75', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '-0.23'}, {'value': '-0.37', 'spread': '0.77', 'groupId': 'OG002', 'lowerLimit': '-0.47', 'upperLimit': '-0.27'}]}]}, {'title': 'Nasal Itching: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.79', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '-0.22'}, {'value': '-0.33', 'spread': '0.82', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '-0.23'}, {'value': '-0.15', 'spread': '0.80', 'groupId': 'OG002', 'lowerLimit': '-0.25', 'upperLimit': '-0.05'}]}]}, {'title': 'Nasal Itching: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.84', 'groupId': 'OG000', 'lowerLimit': '-0.55', 'upperLimit': '-0.33'}, {'value': '-0.44', 'spread': '0.88', 'groupId': 'OG001', 'lowerLimit': '-0.55', 'upperLimit': '-0.34'}, {'value': '-0.35', 'spread': '0.88', 'groupId': 'OG002', 'lowerLimit': '-0.45', 'upperLimit': '-0.24'}]}]}, {'title': 'Nasal Itching: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.91', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '-0.53'}, {'value': '-0.58', 'spread': '0.86', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '-0.48'}, {'value': '-0.52', 'spread': '0.84', 'groupId': 'OG002', 'lowerLimit': '-0.62', 'upperLimit': '-0.42'}]}]}], 'analyses': [{'pValue': '0.547', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.08', 'estimateComment': 'Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.067', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.01', 'estimateComment': 'Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.895', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.13', 'estimateComment': 'Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.627', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.17', 'estimateComment': 'Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.535', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.18', 'estimateComment': 'Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.557', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.18', 'estimateComment': 'Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.119', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.03', 'estimateComment': 'Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.403', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.08', 'estimateComment': 'Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Finding Score Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Swelling of INCM: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.70', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '-0.14'}, {'value': '-0.17', 'spread': '0.68', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '-0.08'}, {'value': '-0.13', 'spread': '0.71', 'groupId': 'OG002', 'lowerLimit': '-0.22', 'upperLimit': '-0.05'}]}]}, {'title': 'Swelling of INCM: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.71', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '-0.25'}, {'value': '-0.31', 'spread': '0.69', 'groupId': 'OG001', 'lowerLimit': '-0.40', 'upperLimit': '-0.21'}, {'value': '-0.34', 'spread': '0.78', 'groupId': 'OG002', 'lowerLimit': '-0.43', 'upperLimit': '-0.24'}]}]}, {'title': 'Swelling of INCM: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.74', 'groupId': 'OG000', 'lowerLimit': '-0.48', 'upperLimit': '-0.28'}, {'value': '-0.34', 'spread': '0.71', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '-0.24'}, {'value': '-0.32', 'spread': '0.82', 'groupId': 'OG002', 'lowerLimit': '-0.41', 'upperLimit': '-0.22'}]}]}, {'title': 'Coloring of INCM: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.86', 'groupId': 'OG000', 'lowerLimit': '-0.37', 'upperLimit': '-0.16'}, {'value': '-0.26', 'spread': '0.79', 'groupId': 'OG001', 'lowerLimit': '-0.36', 'upperLimit': '-0.15'}, {'value': '-0.26', 'spread': '0.81', 'groupId': 'OG002', 'lowerLimit': '-0.36', 'upperLimit': '-0.15'}]}]}, {'title': 'Coloring of INCM: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.88', 'groupId': 'OG000', 'lowerLimit': '-0.47', 'upperLimit': '-0.24'}, {'value': '-0.38', 'spread': '0.89', 'groupId': 'OG001', 'lowerLimit': '-0.49', 'upperLimit': '-0.27'}, {'value': '-0.40', 'spread': '0.91', 'groupId': 'OG002', 'lowerLimit': '-0.51', 'upperLimit': '-0.28'}]}]}, {'title': 'Coloring of INCM: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.97', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '-0.36'}, {'value': '-0.48', 'spread': '0.85', 'groupId': 'OG001', 'lowerLimit': '-0.60', 'upperLimit': '-0.37'}, {'value': '-0.45', 'spread': '0.96', 'groupId': 'OG002', 'lowerLimit': '-0.57', 'upperLimit': '-0.33'}]}]}, {'title': 'NDP: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '-0.14'}, {'value': '-0.24', 'spread': '0.75', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '-0.15'}, {'value': '-0.18', 'spread': '0.65', 'groupId': 'OG002', 'lowerLimit': '-0.27', 'upperLimit': '-0.09'}]}]}, {'title': 'NDP: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.75', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '-0.24'}, {'value': '-0.36', 'spread': '0.75', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '-0.26'}, {'value': '-0.41', 'spread': '0.75', 'groupId': 'OG002', 'lowerLimit': '-0.50', 'upperLimit': '-0.31'}]}]}, {'title': 'NDP: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.71', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '-0.32'}, {'value': '-0.38', 'spread': '0.76', 'groupId': 'OG001', 'lowerLimit': '-0.48', 'upperLimit': '-0.29'}, {'value': '-0.44', 'spread': '0.76', 'groupId': 'OG002', 'lowerLimit': '-0.54', 'upperLimit': '-0.35'}]}]}], 'analyses': [{'pValue': '0.376', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.07', 'estimateComment': 'Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.714', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.11', 'estimateComment': 'Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.725', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.13', 'estimateComment': 'Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.708', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.13', 'estimateComment': 'Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.680', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.16', 'estimateComment': 'Difference in LS Means for Change From Baseline in NDP at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.373', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.19', 'estimateComment': 'Difference in LS Means for Change From Baseline in NDP at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eye Symptom Score Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '-0.08'}, {'value': '-0.24', 'spread': '0.71', 'groupId': 'OG001', 'lowerLimit': '-0.34', 'upperLimit': '-0.15'}, {'value': '-0.13', 'spread': '0.74', 'groupId': 'OG002', 'lowerLimit': '-0.22', 'upperLimit': '-0.04'}]}]}, {'title': 'Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '-0.18'}, {'value': '-0.35', 'spread': '0.76', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '-0.25'}, {'value': '-0.26', 'spread': '0.83', 'groupId': 'OG002', 'lowerLimit': '-0.36', 'upperLimit': '-0.16'}]}]}, {'title': 'Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.84', 'groupId': 'OG000', 'lowerLimit': '-0.48', 'upperLimit': '-0.28'}, {'value': '-0.44', 'spread': '0.77', 'groupId': 'OG001', 'lowerLimit': '-0.54', 'upperLimit': '-0.34'}, {'value': '-0.37', 'spread': '0.79', 'groupId': 'OG002', 'lowerLimit': '-0.46', 'upperLimit': '-0.27'}]}]}], 'analyses': [{'pValue': '0.849', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.12', 'estimateComment': 'Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.260', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.06', 'estimateComment': 'Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Day 3 (n=199, 201, 200)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 (n=200, 203, 201)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=200, 203, 201)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.340', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.826', 'ciLowerLimit': '0.558', 'ciUpperLimit': '1.223', 'estimateComment': 'Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \\>1 is in favor of the first group of the pairwise comparison.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors'}, {'pValue': '0.159', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.755', 'ciLowerLimit': '0.510', 'ciUpperLimit': '1.116', 'estimateComment': 'Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \\>1 is in favor of the first group of the pairwise comparison.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3, Week 1, Week 2', 'description': 'The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.63', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '-0.10'}, {'value': '-0.19', 'spread': '0.58', 'groupId': 'OG001', 'lowerLimit': '-0.27', 'upperLimit': '-0.12'}, {'value': '-0.07', 'spread': '0.62', 'groupId': 'OG002', 'lowerLimit': '-0.15', 'upperLimit': '0.00'}]}]}, {'title': 'Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.69', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '-0.13'}, {'value': '-0.21', 'spread': '0.68', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '-0.12'}, {'value': '-0.20', 'spread': '0.64', 'groupId': 'OG002', 'lowerLimit': '-0.28', 'upperLimit': '-0.11'}]}]}, {'title': 'Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.73', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '-0.16'}, {'value': '-0.29', 'spread': '0.69', 'groupId': 'OG001', 'lowerLimit': '-0.38', 'upperLimit': '-0.20'}, {'value': '-0.27', 'spread': '0.71', 'groupId': 'OG002', 'lowerLimit': '-0.36', 'upperLimit': '-0.19'}]}]}], 'analyses': [{'pValue': '0.705', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.14', 'estimateComment': 'Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.782', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.10', 'estimateComment': 'Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Sneezing: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.72', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '-0.18'}, {'value': '-0.32', 'spread': '0.76', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '-0.23'}, {'value': '-0.23', 'spread': '0.79', 'groupId': 'OG002', 'lowerLimit': '-0.32', 'upperLimit': '-0.13'}]}]}, {'title': 'Sneezing: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.72', 'groupId': 'OG000', 'lowerLimit': '-0.48', 'upperLimit': '-0.29'}, {'value': '-0.40', 'spread': '0.84', 'groupId': 'OG001', 'lowerLimit': '-0.49', 'upperLimit': '-0.30'}, {'value': '-0.30', 'spread': '0.75', 'groupId': 'OG002', 'lowerLimit': '-0.39', 'upperLimit': '-0.20'}]}]}, {'title': 'Sneezing: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.81', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '-0.32'}, {'value': '-0.45', 'spread': '0.86', 'groupId': 'OG001', 'lowerLimit': '-0.55', 'upperLimit': '-0.35'}, {'value': '-0.33', 'spread': '0.81', 'groupId': 'OG002', 'lowerLimit': '-0.44', 'upperLimit': '-0.23'}]}]}, {'title': 'Rhinorrhea: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '-0.11'}, {'value': '-0.29', 'spread': '0.74', 'groupId': 'OG001', 'lowerLimit': '-0.39', 'upperLimit': '-0.19'}, {'value': '-0.17', 'spread': '0.80', 'groupId': 'OG002', 'lowerLimit': '-0.27', 'upperLimit': '-0.08'}]}]}, {'title': 'Rhinorrhea: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.81', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '-0.18'}, {'value': '-0.36', 'spread': '0.81', 'groupId': 'OG001', 'lowerLimit': '-0.46', 'upperLimit': '-0.26'}, {'value': '-0.34', 'spread': '0.84', 'groupId': 'OG002', 'lowerLimit': '-0.44', 'upperLimit': '-0.23'}]}]}, {'title': 'Rhinorrhea: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.85', 'groupId': 'OG000', 'lowerLimit': '-0.45', 'upperLimit': '-0.22'}, {'value': '-0.38', 'spread': '0.86', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.27'}, {'value': '-0.45', 'spread': '0.88', 'groupId': 'OG002', 'lowerLimit': '-0.57', 'upperLimit': '-0.34'}]}]}, {'title': 'Nasal Congestion: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.71', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '-0.09'}, {'value': '-0.17', 'spread': '0.73', 'groupId': 'OG001', 'lowerLimit': '-0.27', 'upperLimit': '-0.08'}, {'value': '-0.18', 'spread': '0.75', 'groupId': 'OG002', 'lowerLimit': '-0.28', 'upperLimit': '-0.09'}]}]}, {'title': 'Nasal Congestion: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.69', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '-0.13'}, {'value': '-0.24', 'spread': '0.79', 'groupId': 'OG001', 'lowerLimit': '-0.34', 'upperLimit': '-0.14'}, {'value': '-0.25', 'spread': '0.83', 'groupId': 'OG002', 'lowerLimit': '-0.35', 'upperLimit': '-0.15'}]}]}, {'title': 'Nasal Congestion: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': '-034', 'upperLimit': '-0.12'}, {'value': '-0.26', 'spread': '0.88', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '-0.15'}, {'value': '-0.32', 'spread': '0.78', 'groupId': 'OG002', 'lowerLimit': '-0.43', 'upperLimit': '-0.20'}]}]}, {'title': 'Nasal Itching: Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '-0.19'}, {'value': '-0.35', 'spread': '0.85', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '-0.25'}, {'value': '-0.22', 'spread': '0.77', 'groupId': 'OG002', 'lowerLimit': '-0.33', 'upperLimit': '-0.12'}]}]}, {'title': 'Nasal Itching: Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.88', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '-0.30'}, {'value': '-0.42', 'spread': '0.80', 'groupId': 'OG001', 'lowerLimit': '-0.53', 'upperLimit': '-0.32'}, {'value': '-0.39', 'spread': '0.87', 'groupId': 'OG002', 'lowerLimit': '-0.50', 'upperLimit': '-0.29'}]}]}, {'title': 'Nasal Itching: Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.92', 'groupId': 'OG000', 'lowerLimit': '-0.64', 'upperLimit': '-0.40'}, {'value': '-0.47', 'spread': '0.90', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.36'}, {'value': '-0.44', 'spread': '0.87', 'groupId': 'OG002', 'lowerLimit': '-0.56', 'upperLimit': '-0.33'}]}]}], 'analyses': [{'pValue': '0.175', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.04', 'estimateComment': 'Difference in LS Means for Change from Baseline in Sneezing at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.098', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.02', 'estimateComment': 'Difference in LS Means for Change from Baseline in Sneezing at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.27', 'estimateComment': 'Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.375', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.22', 'estimateComment': 'Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.285', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.24', 'estimateComment': 'Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.490', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.21', 'estimateComment': 'Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.345', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.08', 'estimateComment': 'Difference in LS Means for Change from Baseline in Nasal Itching at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.699', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.13', 'estimateComment': 'Difference in LS Means for Change from Baseline in Nasal Itching at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eye Symptom Score Reported in Participant Diaries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'classes': [{'title': 'Change from BL at Day 3', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.73', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '-0.19'}, {'value': '-0.25', 'spread': '0.72', 'groupId': 'OG001', 'lowerLimit': '-0.34', 'upperLimit': '-0.15'}, {'value': '-0.20', 'spread': '0.83', 'groupId': 'OG002', 'lowerLimit': '-0.30', 'upperLimit': '-0.11'}]}]}, {'title': 'Change from BL at Week 1', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.82', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '-0.21'}, {'value': '-0.33', 'spread': '0.75', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '-0.24'}, {'value': '-0.26', 'spread': '0.80', 'groupId': 'OG002', 'lowerLimit': '-0.35', 'upperLimit': '-0.16'}]}]}, {'title': 'Change from BL at Week 2', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.80', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '-0.22'}, {'value': '-0.35', 'spread': '0.82', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '-0.24'}, {'value': '-0.27', 'spread': '0.84', 'groupId': 'OG002', 'lowerLimit': '-0.38', 'upperLimit': '-0.17'}]}]}], 'analyses': [{'pValue': '0.414', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.08', 'estimateComment': 'Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '0.281', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.06', 'estimateComment': 'Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'FG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '202'}]}, {'type': 'Treated', 'achievements': [{'comment': 'One randomized participant did not receive study drug.', 'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'comment': 'One randomized participant did not receive study drug.', 'groupId': 'FG002', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '608', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks'}, {'id': 'BG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '33.7', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '34.2', 'spread': '12.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '266', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 608}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2013-08-05', 'resultsFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-24', 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2', 'timeFrame': 'Baseline and Week 2', 'description': 'The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.'}, {'measure': 'Number of Participants Experiencing an Adverse Event (AE)', 'timeFrame': 'Up to Week 4', 'description': 'An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.'}, {'measure': 'Number of Participants Discontinuing Study Drug Due to an AE', 'timeFrame': 'Up to Week 2', 'description': 'An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1', 'timeFrame': 'Baseline and Day 3, Week 1', 'description': 'The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.'}, {'measure': 'Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.'}, {'measure': 'Change From Baseline in Nasal Finding Score Assessed by the Investigator', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.'}, {'measure': 'Change From Baseline in Eye Symptom Score Assessed by the Investigator', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.'}, {'measure': 'Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator', 'timeFrame': 'Day 3, Week 1, Week 2', 'description': 'The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.'}, {'measure': 'Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.'}, {'measure': 'Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.'}, {'measure': 'Change From Baseline in Eye Symptom Score Reported in Participant Diaries', 'timeFrame': 'Baseline and Day 3, Week 1, Week 2', 'description': 'Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinitis', 'Allergic Rhinitis', 'Nose Diseases', 'Respiratory Tract Diseases', 'Immune System Diseases', 'Cholinergic Antagonists', 'Cholinergic Agents', 'Neurotransmitter Agents', 'Histamine H1 Antagonists, Non-Sedating', 'Histamine H1 Antagonists', 'Histamine Antagonists', 'Histamine Agents'], 'conditions': ['Perennial Allergic Rhinitis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Okamoto Y, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with perennial allergic rhinitis: A randomized controlled trial. J Clin Therapeut Med. 2016;32(12):967-978 [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=12'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with perennial allergic rhinitis\n* Outpatient.\n\nExclusion Criteria:\n\n* Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)\n* Coexisting infections or systemic mycosis for which there are no effective antibiotics\n* Asthma complication under treatment\n* Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed\n* Vasomotor rhinitis or eosinophilic rhinitis\n* Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug\n* History of hypersensitivity to antihistamines or study drug\n* Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months\n* Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent\n* Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor\n* History of malignancy or clinically important hematological disorder\n* History of severe drug allergy (e.g., anaphylactoid reaction).'}, 'identificationModule': {'nctId': 'NCT01918033', 'briefTitle': 'A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase III, Multi-Center, Randomized, Parallel-Group, Placebo-Controlled and Double- Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': '4117-200'}, 'secondaryIdInfos': [{'id': '132244', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desloratadine 5 mg', 'description': 'Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks', 'interventionNames': ['Drug: Desloratadine 5 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Desloratadine 10 mg', 'description': 'Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks', 'interventionNames': ['Drug: Desloratadine 5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive two placebo tablets orally once daily for up to 2 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Desloratadine 5 mg', 'type': 'DRUG', 'description': 'Desloratadine 5 mg tablets', 'armGroupLabels': ['Desloratadine 10 mg', 'Desloratadine 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to desloratadine 5 mg tablets', 'armGroupLabels': ['Desloratadine 5 mg', 'Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}