Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-28 @ 10:11 PM
Study NCT ID:
NCT04881461
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alk.net', 'phone': '+4545747576', 'title': 'Senior Director, Clinical Data Science, Global Clinical Development', 'organization': 'ALK-Abelló A/S'}, 'certainAgreement': {'otherDetails': "No publication can be made before the first multi-center publication. PI shall allow Sponsor (S) no less than 60 days to review publications and presentations. S can comment and require removal of confidential information. Upon S request, PI must delay the publication or presentation for 6 months to permit S to file a patent application or take other steps to protect S' information. Any other public statements regarding the trial requires prior written consent from S.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.', 'description': 'All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 111, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 128, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 50, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 44, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 75, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 67, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 49, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mouth swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.10', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.60', 'ciUpperLimit': '3.17', 'pValueComment': 'Adjusted P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.39', 'pValueComment': 'Adjusted P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.10', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '6.76', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '2.67', 'pValueComment': 'Observed P-value', 'estimateComment': 'Placebo vs 5-grass SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4984', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.30', 'pValueComment': 'Observed P-value', 'estimateComment': 'Placebo vs 5-grass SLIT drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4438', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.27', 'pValueComment': 'Observed P-value', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0363', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.38', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.42', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '6.23', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0329', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.06', 'ciUpperLimit': '2.31', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand..', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.58', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '4.86', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.66', 'ciUpperLimit': '2.79', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.92', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '1.23', 'pValueComment': 'Observed P-value', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.82', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.79', 'pValueComment': 'Observed P-value', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.46', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0549', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '1.15', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.34', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.93', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.77', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.95', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.04', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.63', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'OG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.62', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.71', 'pValueComment': 'Observed P-value.', 'estimateComment': 'Placebo vs 5-grass mix SLIT-drops', 'groupDescription': 'The null hypothesis was defined as "no difference in means between treatment arms". The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction'}], 'paramType': 'MEAN', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'FG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized and treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'comment': 'Completed trial', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason stated as "other" in CRF', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '445 participants were randomized and treated. Participants were recruited from 45 sites in 6 countries (Czechia, Estonia, France, Latvia, Lithuania, and Poland).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'BG001', 'title': '5-grass Mix SLIT-drops', 'description': 'Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ongoing asthma', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized and treated participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-12', 'size': 1054349, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-02T08:51', 'hasProtocol': True}, {'date': '2023-10-27', 'size': 1007291, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-02T08:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2021-03-18', 'resultsFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.'}], 'secondaryOutcomes': [{'measure': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.'}, {'measure': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.'}, {'measure': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.'}, {'measure': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS.'}, {'measure': 'Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS.'}, {'measure': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.'}, {'measure': 'Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 1st PGPS (14 days)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)', 'timeFrame': 'During the 2nd PGPS (14 days)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 1st EGPS (observed mean duration of approximately 8 weeks)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.'}, {'measure': 'Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)', 'timeFrame': 'During the 2nd EGPS (observed mean duration of approximately 9 weeks)', 'description': 'The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergic rhinoconjunctivitis', 'Adults', 'Grass'], 'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)\n\nThe study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.\n\nThe trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.', 'detailedDescription': 'This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged ≥18 years on the day informed consent is obtained\n2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma\n3. A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season\n4. Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense\n5. Positive skin prick test to Phleum pratense at screening\n\nExclusion Criteria:\n\n1. Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods\n2. Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids\n3. SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months\n4. SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months\n5. Ongoing treatment with any allergy immunotherapy product\n6. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening'}, 'identificationModule': {'nctId': 'NCT04881461', 'acronym': 'Rhapsody', 'briefTitle': 'A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'SU-G-01'}, 'secondaryIdInfos': [{'id': '2020-000455-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '5-grass mix SLIT-drops', 'description': 'Grass mix sublingual allergy immunotherapy drops One single-dose container (0.5 ml) once daily. 50 SRU/day for five consecutive days followed by 150 SRU/day for five additional consecutive days. Maintenance: 300 SRU/day from day 11.', 'interventionNames': ['Drug: 5-grass mix SLIT-drops']}], 'interventions': [{'name': '5-grass mix SLIT-drops', 'type': 'DRUG', 'otherNames': ['SLIToneULTRA'], 'description': 'Sublingual allergy immunotherapy drops, for daily administration', 'armGroupLabels': ['5-grass mix SLIT-drops']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice u Sv. Anny - FNUSA', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '37001', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Ambulance alergologie a klinicke imunologie - Ceske Budejovice', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '46601', 'city': 'Jablonec nad Nisou', 'country': 'Czechia', 'facility': 'Alergopraktik s.r.o.', 'geoPoint': {'lat': 50.72431, 'lon': 15.17108}}, {'zip': '58601', 'city': 'Jihlava', 'country': 'Czechia', 'facility': 'Allergology Jihlava', 'geoPoint': {'lat': 49.3961, 'lon': 15.59124}}, {'zip': '46001', 'city': 'Liberec', 'country': 'Czechia', 'facility': 'Alergologicka Ambulance - Liberec', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'zip': '570 01', 'city': 'Litomyšl', 'country': 'Czechia', 'facility': 'Alergomyšl s.r.o', 'geoPoint': {'lat': 49.86809, 'lon': 16.31298}}, {'zip': '53002', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Acredula Benedicta s.r.o.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '39002', 'city': 'Tábor', 'country': 'Czechia', 'facility': 'KASMED s.r.o.', 'geoPoint': {'lat': 49.41441, 'lon': 14.6578}}, {'zip': '54101', 'city': 'Trutnov', 'country': 'Czechia', 'facility': 'MUJ ALERGOLOG s.r.o.', 'geoPoint': {'lat': 50.56101, 'lon': 15.9127}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre Foundation', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '42100', 'city': 'Loiré', 'state': 'Saint-Étienne', 'country': 'France', 'facility': 'Hopital Privé de la Loire', 'geoPoint': {'lat': 47.61477, 'lon': -0.97891}}, {'zip': '31150', 'city': 'Fenouillet', 'country': 'France', 'facility': 'Cabinet medical', 'geoPoint': {'lat': 43.68041, 'lon': 1.392}}, {'zip': '83400', 'city': 'Hyères', 'country': 'France', 'facility': 'Cabinet medical', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '37300', 'city': 'Joué-lès-Tours', 'country': 'France', 'facility': 'Cabinet medical', 'geoPoint': {'lat': 47.34907, 'lon': 0.66513}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Cabinet medical', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44400', 'city': 'Rezé', 'country': 'France', 'facility': 'Cabinet médical', 'geoPoint': {'lat': 47.19058, 'lon': -1.56885}}, {'zip': '02100', 'city': 'Saint-Quentin', 'country': 'France', 'facility': 'Cabinet medical', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Nouvel Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Hôpital Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': 'LV-2164', 'city': 'Ādaži', 'country': 'Latvia', 'facility': 'M & M Centrs LTD', 'geoPoint': {'lat': 57.0708, 'lon': 24.33678}}, {'zip': 'LV-4501', 'city': 'Balvi', 'country': 'Latvia', 'facility': 'Balvu and Gulbenes hospital union', 'geoPoint': {'lat': 57.1313, 'lon': 27.26583}}, {'zip': 'LV-5401', 'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Daugavpils Regional hospital, Outpatient clinic', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'zip': 'LV-4601', 'city': 'Rēzekne', 'country': 'Latvia', 'facility': "Vevere Viktorija - Doctor's Practice in Pneumology and Allergology", 'geoPoint': {'lat': 56.51028, 'lon': 27.34}}, {'zip': 'LV-1003', 'city': 'Riga', 'country': 'Latvia', 'facility': "Ozola Inese - Family doctor's practice", 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1003', 'city': 'Riga', 'country': 'Latvia', 'facility': 'The Centre of Investigation and Treatment of Allergic Diseases', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '49387', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'JSC Ausros Medicinos Centras', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '50161', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian University of Health Sciences Kauno klinikos', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '92231', 'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'JSC Inlita, Klaipedos CTC', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'zip': '01118', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'JSC Seimos gydytojas', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '06256', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'JSC Center of Innovative Allergology', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '08406', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'JSC INLITA, Santaros CTC', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '08564', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Allergy Clinic JSC Perspektyvos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': 'LT-08109', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'JSC Center for Diagnosis and Treatment of Allergic Diseases', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '60-693', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '30-033', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Grażyna Pulka Centrum Medyczne ALL-MED', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '33-100', 'city': 'Tarnów', 'state': 'Maopolskie', 'country': 'Poland', 'facility': 'Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '25-017', 'city': 'Kielce', 'country': 'Poland', 'facility': 'Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'zip': '31-033', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Usług Medycznych Dyga-Med', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-159', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '33-559', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Barbara Rewerska Diamond Clinic', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-552', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-214', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Centrum Alergologii T.Hofman Sp. Z o.o.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '60-537', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Snzoz Imedica', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '35051', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '97-200', 'city': 'Tomaszów Mazowiecki', 'country': 'Poland', 'facility': 'Gabinet Lekarski Bozena Kubicka-Kozik', 'geoPoint': {'lat': 51.53131, 'lon': 20.00855}}, {'zip': '53-201', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '53-428', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '54-239', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Lekarze Specjaliści Malolepszy i Partnerzy', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Laurent Guilleminault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Hôpital Larrey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}