Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-03-09 @ 9:20 PM
Study NCT ID:
NCT03101267
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2017-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose-finding Study of ASP4070
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '+81-3-3244-6500 Japanese only', 'title': 'Clinical Trial Disclosure', 'organization': 'Astellas Pharma Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).', 'description': 'SAF consisted of all participants who were vaccinated with the study drug at least once.', 'eventGroups': [{'id': 'EG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 47, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 41, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 23, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 24, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 32, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 71, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 62, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vaccination site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 179, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 134, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 27, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 146, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 43, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Appendiceal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Pre-Exposure in Mean Total 3 Nasal Symptom Score (3TNSS) 120 to 180 Minutes After Start of Cedar Pollen Exposure on Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.04', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '1.98', 'spread': '1.34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.777', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.69', 'groupDescription': '3TNSS treatment comparison', 'statisticalMethod': 'Mixed model for repeated measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.983', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.59', 'groupDescription': '3TNSS treatment comparison', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)', 'description': 'Participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interferes with the activities of daily living).\n\n3TNSS was a summed score of each symptom, and mean of 3TNSS at 120 to 180 min is the average of 5 timepoints of 3TNSS score, which ranged from 0 to 12. Higher 3TNSS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all participants who were randomized, vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.21', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '4.02', 'spread': '2.51', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '3.32', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.71', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '2.62', 'spread': '1.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.710', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '1.10', 'groupDescription': '4TNSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.872', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.99', 'groupDescription': '4TNSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.701', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '1.08', 'groupDescription': '4TNSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.925', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.86', 'groupDescription': '4TNSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.690', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.97', 'groupDescription': '4TNSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.868', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.87', 'groupDescription': '4TNSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each symptom (sneezing, nasal discharge, nasal congestion and itchy nose) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living). 4TNSS was a summed score of each symptom, and mean of 4TNSS at 120 to 180 min is the average of 5 timepoints of 4TNSS score, which ranged from 0 to 16. Higher 4TNSS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.39', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.502', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.29', 'groupDescription': 'Sneezing score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.879', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.20', 'groupDescription': 'Sneezing score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.444', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.22', 'groupDescription': 'Sneezing score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.987', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.16', 'groupDescription': 'Sneezing score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.645', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.18', 'groupDescription': 'Sneezing score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.357', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.08', 'groupDescription': 'Sneezing score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for sneezing using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.82', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '1.27', 'spread': '0.80', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.472', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.44', 'groupDescription': 'Nasal discharge score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.497', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.21', 'groupDescription': 'Nasal discharge score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.821', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.36', 'groupDescription': 'Nasal discharge score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.414', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.19', 'groupDescription': 'Nasal discharge score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.414', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.41', 'groupDescription': 'Nasal discharge score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.566', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.37', 'groupDescription': 'Nasal discharge score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for nasal discharge using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '1.18', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '0.77', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.822', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.30', 'groupDescription': 'Nasal congestion score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.587', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.42', 'groupDescription': 'Nasal congestion score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.975', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.31', 'groupDescription': 'Nasal congestion score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.980', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.31', 'groupDescription': 'Nasal congestion score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.621', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.21', 'groupDescription': 'Nasal congestion score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.831', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.25', 'groupDescription': 'Nasal congestion score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for nasal congestion using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.80', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.864', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.35', 'groupDescription': 'Itchy nose score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.502', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.43', 'groupDescription': 'Itchy nose score treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.652', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.40', 'groupDescription': 'Itchy nose score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.633', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.41', 'groupDescription': 'Itchy nose score treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.596', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.35', 'groupDescription': 'Itchy nose score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.34', 'groupDescription': 'Itchy nose score treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for itchy nose using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.71', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.336', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.65', 'groupDescription': 'TNNSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.102', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.80', 'groupDescription': 'TNNSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.625', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.56', 'groupDescription': 'TNNSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.145', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.78', 'groupDescription': 'TNNSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.364', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.59', 'groupDescription': 'TNNSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.082', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.76', 'groupDescription': 'TNNSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each non-nasal symptom (itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living).\n\nTNNSS was a summed score of each symptom, and mean of TNNSS at 120 to 180 min is the average of 5 timepoints of TNNSS score, which ranged from 0 to 8. Higher TNNSS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.66', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.50', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.623', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.35', 'groupDescription': 'Itchy eyes treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.288', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.43', 'groupDescription': 'Itchy eyes treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.830', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.30', 'groupDescription': 'Itchy eyes treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.208', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.44', 'groupDescription': 'Itchy eyes treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.616', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.31', 'groupDescription': 'Itchy eyes treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.207', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.41', 'groupDescription': 'Itchy eyes treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for itchy eyes using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.38', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.37', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.157', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.35', 'groupDescription': 'Watery eyes treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.41', 'groupDescription': 'Watery eyes treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.459', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.30', 'groupDescription': 'Watery eyes treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.153', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.38', 'groupDescription': 'Watery eyes treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.195', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.31', 'groupDescription': 'Watery eyes treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.038', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.38', 'groupDescription': 'Watery eyes treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for watery eyes using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '2.67', 'groupId': 'OG001'}, {'value': '3.70', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.28', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '3.07', 'spread': '1.84', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.63', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '2.62', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '1.68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.433', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '1.29', 'groupDescription': '5TSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.479', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.24', 'groupDescription': '5TSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.648', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '1.14', 'groupDescription': '5TSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.654', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '1.14', 'groupDescription': '5TSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.514', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '1.09', 'groupDescription': '5TSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.400', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '1.17', 'groupDescription': '5TSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each 5TSS (sneezing, nasal discharge, nasal congestion, itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living).\n\n5TSS was a summed score of each symptom, and mean of 5TSS at 120 to 180 min is the average of 5 timepoints of 5TSS score, which ranged from 0 to 20. Higher 5TSS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '3.31', 'groupId': 'OG001'}, {'value': '4.63', 'spread': '3.09', 'groupId': 'OG002'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '3.74', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '2.30', 'groupId': 'OG002'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '3.29', 'groupId': 'OG001'}, {'value': '3.02', 'spread': '2.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.505', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference,', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '1.54', 'pValueComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.', 'groupDescription': '6TSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.451', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference,', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '1.58', 'groupDescription': '6TSS treatment comparison at day 127', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.623', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference,', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '1.46', 'groupDescription': '6TSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.620', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference,', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '1.46', 'groupDescription': '6TSS treatment comparison at day 155', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.504', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference,', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '1.37', 'groupDescription': '6TSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}, {'pValue': '0.414', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference,', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '1.45', 'groupDescription': '6TSS treatment comparison at day 183', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each 6TSS (sneezing, nasal discharge, nasal congestion, itchy nose, itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living).\n\n6TSS was a summed score of each symptom, and mean of 6TSS at 120 to 180 min is the average of 5 timepoints of 6TSS score, which ranged from 0 to 24. Higher 6TSS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '30.0'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '30.0'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '30.0'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '30.0'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '30.0'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '30.0'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.0', 'comment': '95% Confidential Interval (CI) was not technically defined due to insufficient number of participants with events around the percentile.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '45.0'}, {'value': '30.0', 'comment': '95% Confidential Interval (CI) was not technically defined due to insufficient number of participants with events around the percentile.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutes', 'description': 'Time point when the score of nasal or eye symptom worsens by 1 or more as compared to before cedar pollen exposure were assessed.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127: 0-30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 30-60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '1.58', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 60-90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.58', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '1.88', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 90-120 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '1.67', 'spread': '2.24', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 120-150 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.49', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '1.67', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 150-180 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '1.79', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 0-30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '1.52', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 30-60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.12', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '1.64', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 60-90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '1.75', 'spread': '1.84', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 90-120 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 120-150 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 150-180 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '1.70', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 0-30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '1.16', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 30-60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '1.39', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 60-90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '1.93', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 90-120 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 120-150 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 150-180 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '1.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 127: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 155: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 183: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min', 'description': 'Nasal discharge amount was calculated by the difference in the weight of the tissue paper before and after use by participants who were instructed to use pre-allocated tissues for blowing their nose.', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Sneezing Count Per 30 Minutes During Cedar Pollen Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'Day 127: 0-30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 30-60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 60-90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 90-120 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 120-150 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 127: 150-180 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 0-30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 30-60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 60-90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 90-120 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 120-150 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 155: 150-180 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 0-30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 30-60 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 60-90 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 90-120 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 120-150 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 183: 150-180 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 127: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 155: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 183: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min', 'description': 'Sneezing count per 30 minutes were measured during chamber exposure.', 'unitOfMeasure': 'sneezes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE) During the Primary Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Life-threatening Possibility', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Drug-related TEAE', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Device-Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Drug-related serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to withdrawal of treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Drug-related TEAE leading to withdrawal of treat.', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Local reaction', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs other than local or systemic reactions', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Drug-related TEAEs other than local or systemic', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to the end of primary study period (up to 7 days after Day 183)', 'description': 'Treatment emergent adverse events (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug. A drug-related TEAE was a TEAE with either possible or probable relationship to the study drug as assessed by the investigator. Severity of AEs was assessed according to the following 4 levels. Mild: no disruption of normal daily activities, Moderate: affect normal daily activities, Severe: inability to perform daily activities, Life-threatening: necessity for urgent intervention.\n\nIf the investigator or subinvestigator examined the patient and determined that the following items occurred from the date of study drug vaccination until 14 days after vaccination and a relationship with the study drug could not be negated, then it was evaluated as a local/systemic reaction at the vaccination site.\n\n* Local reactions: pain, tenderness, erythema/redness and induration/swelling\n* Systemic reactions: nausea/vomiting, diarrhea, headache, fatigue and myalgia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)', 'description': 'If SAEs occurred, then the participant was to contact the study site. With regard to participants who had discontinued the study during the primary study period, if the study drug had been vaccinated even once, then safety information (SAEs) was collected for 1 year after the final vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'FG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}], 'periods': [{'title': 'Primary Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Pollinosis Symptoms Survey Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 150 participants with cedar pollinosis were enrolled in this study. Participants were randomly allocated to 3 groups in a ratio of 1:1:1 to ASP4070 4 mg group, ASP4070 1 mg group or placebo group.', 'preAssignmentDetails': '"Class of Japanese Red Cedar (JRC) pollen-specific Immunoglobulin E (IgE) antibody test at screening visit 1" and "Change from pre-exposure in mean total 3 nasal symptom (sneezing, nasal discharge and nasal congestion) score 120 to 180 minutes after start of cedar pollen exposure at screening visit 2" were used as stratification.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'BG001', 'title': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38.4', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '38.1', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Class of Japanese Red Cedar (JRC) Specific Immunoglobulin E (IgE) Antibody Test', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}], 'categories': [{'title': '3', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': '4', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': '5', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': '6', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'JRC specific IgE antibody test at screening visit 1 was showed. JRC specific IgE antibody was classified from Class 1 to Class 6. Participants with Class 1 and 2 was excluded in the enrollment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set (FAS) consisted of all participants who were randomized, were vaccinated with the study drug at least once, and had at least 1 measurement for efficacy evaluation obtained after vaccination of the study drug.'}, {'title': 'Change From Pre-exposure in Mean of Total 3 Nasal Symptom Score During 120 to 180 Minutes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.79', 'spread': '1.53', 'groupId': 'BG000'}, {'value': '4.89', 'spread': '1.31', 'groupId': 'BG001'}, {'value': '4.78', 'spread': '1.25', 'groupId': 'BG002'}, {'value': '4.82', 'spread': '1.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'At screening visit 2, participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the score from 0 (None; no symptoms) to 4 (Very severe) every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 3TNSS was a summed score of each symptom, and mean of 3TNSS at 120 to 180 min is the average of 5 timepoints of 3TNSS score, which ranged from 0 to 12. Higher 3TNSS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS'}], 'populationDescription': 'Safety Analysis Set (SAF) consisted of all participants who were vaccinated with the study drug at least once.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-09', 'size': 974864, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-06T21:33', 'hasProtocol': True}, {'date': '2018-06-22', 'size': 785265, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-06T21:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2019-01-04', 'completionDateStruct': {'date': '2018-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2017-04-02', 'dispFirstSubmitQcDate': '2020-06-16', 'resultsFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2017-04-02', 'dispFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-16', 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Pre-Exposure in Mean Total 3 Nasal Symptom Score (3TNSS) 120 to 180 Minutes After Start of Cedar Pollen Exposure on Day 183', 'timeFrame': 'Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)', 'description': 'Participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interferes with the activities of daily living).\n\n3TNSS was a summed score of each symptom, and mean of 3TNSS at 120 to 180 min is the average of 5 timepoints of 3TNSS score, which ranged from 0 to 12. Higher 3TNSS score indicated greater disease activity.'}], 'secondaryOutcomes': [{'measure': 'Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each symptom (sneezing, nasal discharge, nasal congestion and itchy nose) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living). 4TNSS was a summed score of each symptom, and mean of 4TNSS at 120 to 180 min is the average of 5 timepoints of 4TNSS score, which ranged from 0 to 16. Higher 4TNSS score indicated greater disease activity.'}, {'measure': 'Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for sneezing using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)'}, {'measure': 'Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for nasal discharge using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)'}, {'measure': 'Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for nasal congestion using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)'}, {'measure': 'Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for itchy nose using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)'}, {'measure': 'Change From Pre-Exposure in Mean Total Non-Nasal Symptom Score (TNNSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each non-nasal symptom (itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living).\n\nTNNSS was a summed score of each symptom, and mean of TNNSS at 120 to 180 min is the average of 5 timepoints of TNNSS score, which ranged from 0 to 8. Higher TNNSS score indicated greater disease activity.'}, {'measure': 'Change From Pre-Exposure in Mean Itchy Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for itchy eyes using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)'}, {'measure': 'Change From Pre-Exposure in Mean Watery Eyes Score 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for watery eyes using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. The mean of score at 120 to 180 minutes was calculated.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living)'}, {'measure': 'Change From Pre-Exposure in Total 5 Symptom Score (5TSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each 5TSS (sneezing, nasal discharge, nasal congestion, itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living).\n\n5TSS was a summed score of each symptom, and mean of 5TSS at 120 to 180 min is the average of 5 timepoints of 5TSS score, which ranged from 0 to 20. Higher 5TSS score indicated greater disease activity.'}, {'measure': 'Change From Pre-Exposure in Mean Total 6 Symptom Score (6TSS) 120 to 180 Minutes After Cedar Pollen Exposure', 'timeFrame': 'Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183', 'description': 'Participants were assessed for each 6TSS (sneezing, nasal discharge, nasal congestion, itchy nose, itchy eyes and watery eyes) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure.\n\n0: None (no symptoms)\n\n1. Mild (symptoms present but easily tolerated)\n2. Moderate (awareness of symptoms; bothersome, but tolerable)\n3. Severe (definite awareness of symptoms; difficult to tolerate, but did not interfere with the activities of daily living)\n4. Very severe (difficult to tolerate and interfered with the activities of daily living).\n\n6TSS was a summed score of each symptom, and mean of 6TSS at 120 to 180 min is the average of 5 timepoints of 6TSS score, which ranged from 0 to 24. Higher 6TSS score indicated greater disease activity.'}, {'measure': 'Time to Occurrence of Nasal or Eye Symptom From Start of Cedar Pollen Exposure', 'timeFrame': 'Days 127, 155 and 183, from the start of cedar pollen exposure for up to 180 minutes', 'description': 'Time point when the score of nasal or eye symptom worsens by 1 or more as compared to before cedar pollen exposure were assessed.'}, {'measure': 'Amount of Nasal Discharge Per 30 Minutes During Cedar Pollen Exposure', 'timeFrame': 'Day 127: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 155: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 183: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min', 'description': 'Nasal discharge amount was calculated by the difference in the weight of the tissue paper before and after use by participants who were instructed to use pre-allocated tissues for blowing their nose.'}, {'measure': 'Sneezing Count Per 30 Minutes During Cedar Pollen Exposure', 'timeFrame': 'Day 127: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 155: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min, Day 183: 0-30 min, 30-60 min, 60-90 min, 90-120 min, 120-150 min, 150-180 min', 'description': 'Sneezing count per 30 minutes were measured during chamber exposure.'}, {'measure': 'Number of Participants With Adverse Events (AE) During the Primary Study Period', 'timeFrame': 'From first dose of study drug up to the end of primary study period (up to 7 days after Day 183)', 'description': 'Treatment emergent adverse events (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug. A drug-related TEAE was a TEAE with either possible or probable relationship to the study drug as assessed by the investigator. Severity of AEs was assessed according to the following 4 levels. Mild: no disruption of normal daily activities, Moderate: affect normal daily activities, Severe: inability to perform daily activities, Life-threatening: necessity for urgent intervention.\n\nIf the investigator or subinvestigator examined the patient and determined that the following items occurred from the date of study drug vaccination until 14 days after vaccination and a relationship with the study drug could not be negated, then it was evaluated as a local/systemic reaction at the vaccination site.\n\n* Local reactions: pain, tenderness, erythema/redness and induration/swelling\n* Systemic reactions: nausea/vomiting, diarrhea, headache, fatigue and myalgia'}, {'measure': 'Number of Participants With Serious Adverse Events (SAE) During the Long-Term Safety Follow-Up Period', 'timeFrame': 'Up to 9 months after the end of primary study period (primary study period was up to 7 days after Day 183)', 'description': 'If SAEs occurred, then the participant was to contact the study site. With regard to participants who had discontinued the study during the primary study period, if the study drug had been vaccinated even once, then safety information (SAEs) was collected for 1 year after the final vaccination.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cedar pollinosis', 'ASP4070', 'DNA plasmid vaccine'], 'conditions': ['Rhinitis, Allergic, Seasonal']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=361', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.', 'detailedDescription': 'Subjects were vaccinated with ASP4070 or placebo at 2 week intervals. Clinical symptoms were evaluated after cedar pollen exposure in a chamber at 4, 8 and 12 weeks after the last vaccination to identify the timing of the onset of therapeutic effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject who has exhibited symptoms of cedar pollinosis, consisting of nasal symptoms (sneezing, nasal discharge or nasal obstruction) and eye symptoms (itchy eyes or watery eyes) during the pollen dispersal seasons in 2016 and 2017\n* Subject who is positive for the Japanese red cedar (JRC) pollen-specific serum IgE antibody test\n* At screening, subject whose score has worsened compared to baseline over 120 to 180 minutes after cedar pollen exposure in a chamber\n\nExclusion Criteria:\n\n* Subject who has positive the test result of serum IgE antibody specific to other antigen than JRC pollen at screening\n* Subject who has received specific immunotherapy (including desensitization therapy) for cedar pollinosis in the past\n* Subject who has received specific or non-specific immunotherapy within 5 years prior to screening\n* Subject who has received laser therapy or surgery for the treatment of nasal symptoms within 3 years prior to screening.\n* Subject who has a history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products in the past\n* Subject who has a positive test result for hepatitis B surface (HBs) antigen or anti-hepatitis C virus (HCV) antibody\n* Subject who has nasal disease that may interfere with the evaluation\n* Subject who has autoimmune disease or other serious primary disease\n* Subject who was diagnosed with immunodeficiency in the past\n* Subject who has a complication of seasonal allergic rhinitis (due to allergens other than Japanese cedars or cypress), perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis that requires medical treatment\n* Subject who has a complication of cardiovascular disease\n* Subject who has a complication of hepatic disease\n* Subject who has a complication of renal disease\n* Subject who has a complication of respiratory disease\n* Subject has a complication of malignant tumor or has been diagnosed with or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug\n* Subject who was diagnosed with schizophrenia, other mental conditions\n* Subject who has a complication that may have an impact on the results of the local or systemic reaction\n* Subject who has received a vaccination of Cry j 2-LAMP vaccine\n* Subject who has participated in a clinical study of ASP4070 and received a vaccination of the study drug.'}, 'identificationModule': {'nctId': 'NCT03101267', 'briefTitle': 'A Dose-finding Study of ASP4070', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase 2 Dose-finding Study of ASP4070 - A Randomized, Double-blind, Placebo-controlled, Dose-finding Study in Patients With Cedar Pollinosis Using an Environmental Exposure Chamber -', 'orgStudyIdInfo': {'id': '4070-CL-0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP4070 4 mg', 'description': 'Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.', 'interventionNames': ['Drug: ASP4070']}, {'type': 'EXPERIMENTAL', 'label': 'ASP4070 1 mg', 'description': 'Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.', 'interventionNames': ['Drug: ASP4070']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASP4070', 'type': 'DRUG', 'description': 'Intradermal vaccination at 2-week intervals', 'armGroupLabels': ['ASP4070 1 mg', 'ASP4070 4 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intradermal vaccination at 2-week intervals', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00001', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Immunomic Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}