Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-12 @ 1:21 AM
Study NCT ID:
NCT04541004
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adolescent Mite Allergy Safety Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'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': 'ClinicalTrials@alk.net', 'phone': '+45 45747576', 'title': 'David Hal Mollerup, Senior Director', 'organization': 'ALK-Abelló A/S'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).', 'description': 'An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP.\n\nAn AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)', 'otherNumAtRisk': 253, 'deathsNumAtRisk': 253, 'otherNumAffected': 223, 'seriousNumAtRisk': 253, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pharyngeal paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 34, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngeal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 59, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 323, 'numAffected': 132}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 24, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 270, 'numAffected': 101}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 77, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Enlarged uvula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 38, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 87, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lip oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 89, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mouth swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 32, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 68, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 83, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 35, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 421, 'numAffected': 169}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 51, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tongue eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 16, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 79, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one TEAE', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one TEAE', 'unitOfMeasure': 'percent', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '1940', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one TEAE', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one solicited TEAE', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '88.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one solicited TEAE', 'unitOfMeasure': 'percent', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Solicited Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '1796', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one solicited TEAE', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One IMP-related Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one IMP-related AE', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With at Least One IMP-related Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '89.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one IMP-related AE', 'unitOfMeasure': 'percent', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of IMP-related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '1863', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one IMP-related AE', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one treatment-emergent SAE', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one treatment-emergent SAE', 'unitOfMeasure': 'percent', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one treatment-emergent SAE', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet\n\nHDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '253', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.3', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '15.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '4.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking history', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Never', 'measurements': [{'value': '250', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Regularly exposed to tobacco smoke', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '246', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not applicable (current smokers)', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline sensitisations', 'classes': [{'categories': [{'title': 'HDM only', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'HDM and others', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of HDM allergic rhinitis/rhinoconjunctivitis', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '3.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Asthma status', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Inhaled corticosteroids', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of asthma', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 (percentage predicted)', 'classes': [{'categories': [{'measurements': [{'value': '96.10', 'spread': '12.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage predicted FEV1', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 (L)', 'classes': [{'categories': [{'measurements': [{'value': '3.26', 'spread': '0.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-08', 'size': 28589024, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-14T10:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Non applicable'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-armed'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2020-09-01', 'resultsFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-26', 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one TEAE'}, {'measure': 'Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one TEAE'}, {'measure': 'Number of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one TEAE'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one solicited TEAE'}, {'measure': 'Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one solicited TEAE'}, {'measure': 'Number of Solicited Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one solicited TEAE'}, {'measure': 'Number of Subjects With at Least One IMP-related Adverse Event (AE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one IMP-related AE'}, {'measure': 'Proportion of Subjects With at Least One IMP-related Adverse Event (AE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one IMP-related AE'}, {'measure': 'Number of IMP-related Adverse Events (AEs)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one IMP-related AE'}, {'measure': 'Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one treatment-emergent SAE'}, {'measure': 'Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one treatment-emergent SAE'}, {'measure': 'Number of Treatment-emergent Serious Adverse Events (SAEs)', 'timeFrame': 'From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.', 'description': 'At least one treatment-emergent SAE'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergic rhinitis', 'House dust mite', 'Adolescent', 'Pediatric'], 'conditions': ['Allergic Rhinitis', 'Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.\n\nThe purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.\n\nThe trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.', 'detailedDescription': 'This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Male or female subjects aged ≥12 to ≤17 years\n* A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM\n* Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening\n* Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication\n* The subject must be willing and able to comply with trial protocol and adhere to IMP treatment\n\nMain Exclusion Criteria:\n\n* A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)\n* Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1\n* Ongoing treatment with any allergy immunotherapy product at screening\n* Severe chronic oral inflammation\n* A diagnosis or history of eosinophilic oesophagitis\n* Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration\n* Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial\n* Sexually active female of childbearing potential without medically accepted contraceptive method"}, 'identificationModule': {'nctId': 'NCT04541004', 'acronym': 'AMASE', 'briefTitle': 'Adolescent Mite Allergy Safety Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma', 'orgStudyIdInfo': {'id': 'MT-18'}, 'secondaryIdInfos': [{'id': '2020-000446-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HDM SLIT Tablet', 'description': 'House dust mite (HDM) Sublingual allergy immunotherapy tablet', 'interventionNames': ['Biological: HDM SLIT-tablet']}], 'interventions': [{'name': 'HDM SLIT-tablet', 'type': 'BIOLOGICAL', 'otherNames': ['ACARIZAX, ODACTRA'], 'description': 'Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)', 'armGroupLabels': ['HDM SLIT Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28601', 'city': 'Čáslav', 'country': 'Czechia', 'facility': 'Alergologicka ambulance', 'geoPoint': {'lat': 49.91099, 'lon': 15.38972}}, {'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}}, {'city': 'Kolín', 'country': 'Czechia', 'facility': 'Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a', 'geoPoint': {'lat': 50.02806, 'lon': 15.1998}}, {'zip': '28401', 'city': 'Kutná Hora', 'country': 'Czechia', 'facility': 'Alergologicka ordinace', 'geoPoint': {'lat': 49.94839, 'lon': 15.26816}}, {'zip': '57014', 'city': 'Litomyšl', 'country': 'Czechia', 'facility': 'Alergomyšl s.r.o.', 'geoPoint': {'lat': 49.86809, 'lon': 16.31298}}, {'zip': '70900', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Alergologie SKOPKOVA s.r.o.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '39002', 'city': 'Tábor', 'country': 'Czechia', 'facility': 'KASMED s.r.o.', 'geoPoint': {'lat': 49.41441, 'lon': 14.6578}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wrttemberg', 'country': 'Germany', 'facility': 'HNO Praxis am Neckar', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69126', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '63303', 'city': 'Dreieich', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Praxis Dr. Decot', 'geoPoint': {'lat': 50.01997, 'lon': 8.69611}}, {'zip': '49565', 'city': 'Bramsche', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Kinderarztpraxis BramscheDr. Thomas Adelt', 'geoPoint': {'lat': 52.40881, 'lon': 7.97288}}, {'zip': '01067', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'HNO-Praxis Dr. med. Udo Schaefer', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '013999', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Facharzt fr HNO und Allergologie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '39326', 'city': 'Wolmirstedt', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'HNO-Genossenschaft Sachsen-Anhalt E.G.', 'geoPoint': {'lat': 52.24856, 'lon': 11.62945}}, {'zip': '97405', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Ambulancia klinickej imunologie a alergologie', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '08501', 'city': 'Bardejov', 'country': 'Slovakia', 'facility': 'ALIAN s.r.o.', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'zip': '82108', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Jocia s.r.o.', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '06001', 'city': 'Kežmarok', 'country': 'Slovakia', 'facility': 'AlergoImuno centrum s.r.o. - Ambulancia alergologi', 'geoPoint': {'lat': 49.13571, 'lon': 20.43352}}, {'zip': '94501', 'city': 'Komárno', 'country': 'Slovakia', 'facility': 'ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie', 'geoPoint': {'lat': 48.11667, 'lon': 18.31667}}, {'zip': '04022', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Alersa', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '03659', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '05801', 'city': 'Poprad', 'country': 'Slovakia', 'facility': 'NZZ Imunologicka ambulancia', 'geoPoint': {'lat': 49.06144, 'lon': 20.29798}}, {'zip': '08001', 'city': 'Prešov', 'country': 'Slovakia', 'facility': 'Alergo immunological center prešov', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'zip': '901981', 'city': 'Rimavská Sobota', 'country': 'Slovakia', 'facility': 'Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o.', 'geoPoint': {'lat': 48.38284, 'lon': 20.02239}}, {'zip': '94201', 'city': 'Šurany', 'country': 'Slovakia', 'facility': 'Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie', 'geoPoint': {'lat': 48.08613, 'lon': 18.18447}}, {'zip': '91701', 'city': 'Trnava', 'country': 'Slovakia', 'facility': 'Medimun s.r.o.', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}], 'overallOfficials': [{'name': 'Andreas Horn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HNO Praxis am Neckar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}