Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-03 @ 4:28 AM
Study NCT ID:
NCT01469234
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2011-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017336', 'term': 'Loratadine'}, {'id': 'C093230', 'term': 'fexofenadine'}], 'ancestors': [{'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '180 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '4.86', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '5.07', 'groupId': 'OG002'}]}]}, {'title': '195 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '4.87', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '5.31', 'groupId': 'OG002'}]}]}, {'title': '210 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '4.87', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '5.28', 'groupId': 'OG002'}]}]}, {'title': '225 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '4.70', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '5.36', 'groupId': 'OG002'}]}]}, {'title': '240 minutes (n=84, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '4.43', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '5.38', 'groupId': 'OG002'}]}]}, {'title': '255 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '4.47', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '5.51', 'groupId': 'OG002'}]}]}, {'title': '270 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.50', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '5.56', 'groupId': 'OG002'}]}]}, {'title': '285 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '4.76', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '5.76', 'groupId': 'OG002'}]}]}, {'title': '300 minutes (n=84, n=85, n=85)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '4.65', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '5.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.09', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '75 minutes', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '105 minutes', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.16', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': '135 minutes', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': '150 minutes', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '165 minutes', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.17', 'groupId': 'OG002'}]}]}, {'title': '195 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '210 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '225 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '255 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '270 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.35', 'groupId': 'OG002'}]}]}, {'title': '285 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '300 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '315 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '330 minutes', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '345 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '360 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Runny Nose was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.77', 'groupId': 'OG002'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.99', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.04', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.07', 'groupId': 'OG002'}]}]}, {'title': '75 minutes', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.17', 'groupId': 'OG002'}]}]}, {'title': '105 minutes', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.10', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '135 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': '150 minutes', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': '165 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': '195 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '210 minutes', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '225 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '255 minutes', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '270 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '285 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '300 minutes', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '315 minutes', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': '330 minutes', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '345 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': '360 minutes', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Itchy Nose was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.40', 'groupId': 'OG002'}]}]}, {'title': '15 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.37', 'groupId': 'OG002'}]}]}, {'title': '30 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': '45 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.39', 'groupId': 'OG002'}]}]}, {'title': '60 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': '75 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.39', 'groupId': 'OG002'}]}]}, {'title': '90 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.37', 'groupId': 'OG002'}]}]}, {'title': '105 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': '120 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '135 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.48', 'groupId': 'OG002'}]}]}, {'title': '150 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '165 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '180 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '195 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': '210 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '225 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': '240 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '255 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': '270 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.40', 'groupId': 'OG002'}]}]}, {'title': '285 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.42', 'groupId': 'OG002'}]}]}, {'title': '300 minutes (n=84, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': '315 minutes (n=84, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.40', 'groupId': 'OG002'}]}]}, {'title': '330 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': '345 minutes (n=84, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': '360 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Sneezing was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': '75 minutes', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': '105 minutes', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': '135 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '150 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '165 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.16', 'groupId': 'OG002'}]}]}, {'title': '195 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.21', 'groupId': 'OG002'}]}]}, {'title': '210 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': '225 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '255 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': '270 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.21', 'groupId': 'OG002'}]}]}, {'title': '285 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': '300 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '315 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': '330 minutes', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '345 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '360 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Water Eyes was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.08', 'groupId': 'OG002'}]}]}, {'title': '15 minutes (n=85, n=85, n=84)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': '30 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': '45 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '60 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.23', 'groupId': 'OG002'}]}]}, {'title': '75 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '90 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '105 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '120 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '135 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '150 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '165 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '180 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.23', 'groupId': 'OG002'}]}]}, {'title': '195 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '210 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': '225 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '240 minutes (n=84, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '255 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '270 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '285 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.42', 'groupId': 'OG002'}]}]}, {'title': '300 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': '315 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': '330 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': '345 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': '360 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Itchy Eyes was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.76', 'groupId': 'OG002'}]}]}, {'title': '15 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': '30 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': '45 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': '60 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': '75 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '90 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': '105 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '120 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '135 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': '150 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '165 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': '180 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.39', 'groupId': 'OG002'}]}]}, {'title': '195 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '210 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': '225 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '240 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '255 minutes (n=85, n=85, n=84)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '270 minutes (n=85, n=85, n=84)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.46', 'groupId': 'OG002'}]}]}, {'title': '285 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': '300 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': '315 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.39', 'groupId': 'OG002'}]}]}, {'title': '330 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.47', 'groupId': 'OG002'}]}]}, {'title': '345 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': '360 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Nasal Congestion was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}, {'type': 'SECONDARY', 'title': 'Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'classes': [{'title': '0 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.17', 'groupId': 'OG002'}]}]}, {'title': '15 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.09', 'groupId': 'OG002'}]}]}, {'title': '30 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': '45 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.06', 'groupId': 'OG002'}]}]}, {'title': '60 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '75 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': '90 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '105 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': '120 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '135 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': '150 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '165 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '180 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '195 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': '210 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '225 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': '240 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '255 minutes (n=85, n=85, n=84)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': '270 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '285 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': '300 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': '315 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': '330 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.23', 'groupId': 'OG002'}]}]}, {'title': '345 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': '360 minutes (n=85, n=85, n=85)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.\n\nN=Number of Participants Analyzed, n=number of participants with data available at the given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'FG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Loratadine', 'description': 'Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'BG001', 'title': 'Fexofenadine', 'description': 'Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '13.52', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '12.21', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '12.56', 'groupId': 'BG002'}, {'value': '41.7', 'spread': '12.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2011-11-08', 'resultsFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-12', 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.'}], 'secondaryOutcomes': [{'measure': 'Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Runny Nose was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}, {'measure': 'Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Itchy Nose was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}, {'measure': 'Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Sneezing was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}, {'measure': 'Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Water Eyes was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}, {'measure': 'Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Itchy Eyes was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}, {'measure': 'Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Nasal Congestion was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}, {'measure': 'Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point', 'timeFrame': 'From time of sensitization (time 0) to end of visit (~8 hours)', 'description': 'The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point\n\nscale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and\n\nFexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants of child bearing potential must demonstrate a negative\n\nurine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.\n\n* Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.\n* Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.\n* Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.\n* Capable of reading English.\n* Body mass index (BMI) \\<35.\n\nExclusion Criteria:\n\n* Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.\n* Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.\n* Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.\n* History of rhinitis medicamentosa.\n* Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.\n* Asthma, with the exception of mild intermittent asthma.'}, 'identificationModule': {'nctId': 'NCT01469234', 'briefTitle': 'A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber', 'orgStudyIdInfo': {'id': '18126'}, 'secondaryIdInfos': [{'id': 'PT11-37', 'type': 'OTHER', 'domain': 'Consumer Health Care'}, {'id': 'P08712', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'loratadine', 'description': 'Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.', 'interventionNames': ['Drug: loratadine', 'Drug: placebo to fexofenadine']}, {'type': 'EXPERIMENTAL', 'label': 'fexofenadine', 'description': 'Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.', 'interventionNames': ['Drug: fexofenadine', 'Drug: placebo to loratadine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.', 'interventionNames': ['Drug: placebo to loratadine', 'Drug: placebo to fexofenadine']}], 'interventions': [{'name': 'loratadine', 'type': 'DRUG', 'otherNames': ['SCH 029851'], 'description': 'loratadine, one 10 mg tablet, orally', 'armGroupLabels': ['loratadine']}, {'name': 'fexofenadine', 'type': 'DRUG', 'description': 'fexofenadine, one 180 mg tablet, orally', 'armGroupLabels': ['fexofenadine']}, {'name': 'placebo to loratadine', 'type': 'DRUG', 'description': 'one tablet, orally', 'armGroupLabels': ['fexofenadine', 'placebo']}, {'name': 'placebo to fexofenadine', 'type': 'DRUG', 'description': 'one tablet, orally', 'armGroupLabels': ['loratadine', 'placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}