Viewing Study NCT01284634

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 2:39 AM
Ignite Modification Date: 2025-12-30 @ 10:26 AM
Study NCT ID: NCT01284634
Status: COMPLETED
Last Update Posted: 2018-08-08
First Post: 2011-01-26
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@gwpharm.com, medinfo@greenwichbiosciences.com', 'title': 'Medical Enquires', 'organization': 'GW Research Ltd'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Day 77', 'description': 'Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '800 mg GWP42003', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Change of bowel habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrointestinal hypermotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Product size issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Heart sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.68', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '8.60', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '5.28', 'groupId': 'OG002'}, {'value': '6.36', 'spread': '17.97', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.222', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.89', 'ciLowerLimit': '-16.35', 'ciUpperLimit': '2.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.454', 'groupDescription': 'The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.133', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.35', 'ciLowerLimit': '-19.66', 'ciUpperLimit': '0.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.943', 'groupDescription': 'The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.302', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.54', 'ciLowerLimit': '-17.22', 'ciUpperLimit': '4.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.158', 'groupDescription': 'The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to EOT (Day 57) or Early Termination (ET)', 'description': 'Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '-0.62', 'spread': '1.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.', 'unitOfMeasure': 'millimole (mmol)/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.631', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.407', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.432', 'groupId': 'OG002'}, {'value': '-0.34', 'spread': '0.737', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.', 'unitOfMeasure': 'change in ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To The EOT In Mean Serum Triglyceride Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '0.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GWP42003 200 Milligram (mg)/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'FG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'FG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'comment': 'Safety analysis set; analyzed as per actual treatment received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Intent to Treat (ITT) Analysis Set', 'comment': 'Randomized and received at least one dose of study medication and had on-treatment efficacy data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GWP42003 200 mg/Day Dose', 'description': 'Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'BG001', 'title': 'GWP42003 400 mg/Day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'BG002', 'title': 'GWP42003 800 mg/Day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.69', 'spread': '14.62', 'groupId': 'BG000'}, {'value': '49.08', 'spread': '7.72', 'groupId': 'BG001'}, {'value': '46.90', 'spread': '12.57', 'groupId': 'BG002'}, {'value': '50.41', 'spread': '18.41', 'groupId': 'BG003'}, {'value': '46.39', 'spread': '13.29', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: Participants who received at least 1 dose of investigational medicinal product (IMP); analyzed as per actual treatment received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study was partially-blinded. Due to the varying numbers of capsules administered, participants and investigators were not blinded to the treatment cohort (one, two or four capsules), but were blinded to the treatment allocation within each cohort (GWP42003 or placebo)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2011-01-26', 'resultsFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-03', 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels', 'timeFrame': 'Baseline to EOT (Day 57) or Early Termination (ET)', 'description': 'Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.'}, {'measure': 'Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.'}, {'measure': 'Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.'}, {'measure': 'Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.'}, {'measure': 'Change From Baseline To The EOT In Mean Serum Triglyceride Levels', 'timeFrame': 'Baseline to EOT (Day 57) or ET', 'description': 'A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cannabidiol', 'Fatty liver', 'Diabetes', 'Body fat'], 'conditions': ['Fatty Liver']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).', 'detailedDescription': 'This study was conducted as a 10-week (eight-week treatment period and one-week safety follow-up), randomized, partially-blind study that evaluated the effect of GWP42003 in participants with raised liver triglycerides (liver fat ≥5%). Participants were clinically diagnosed with FLD and had liver fat levels ≥5% as measured by Magnetic Resonance Imaging/ Magnetic Resonance Scanning (MRI/MRS), or were willing to undergo MRI/MRS scan at the screening visit to confirm a liver fat content of ≥5%. Eligible participants entered the study at a screening visit (Day -10 to -2) and then returned for a fasted baseline visit (Day 1), a mid-treatment visit (Day 29) and an end of treatment visit (Day 57). Safety follow-up telephone calls took place throughout the treatment period up to Day 64 after completion of treatment or seven days after date of last dose/withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant gave informed consent for participation in the study.\n* Participant was aged 18 years or above.\n* Participant had documented evidence of liver fat content ≥5% as measured by MRI/MRS scanning or a biopsy within two months prior to screening, or willing to undergo an MRI/MRS scan at Visit 1 (Day -10 to -2) to confirm a liver fat content of ≥5%.\n* Participant had, in the opinion of the investigator, no changes in levels of exercise or diet for four weeks (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment, and participant agreed to keep stable for the duration of the study.\n* Participant was able (in the investigator's opinion) and willing to comply with all study requirements.\n* Participant was willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable.\n* Participant was willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.\n\nExclusion Criteria:\n\n* Participant had clinical diagnosis or treatment for Type I/II diabetes.\n* Participant had received an unapproved investigational medicinal product (IMP) within the 30 days prior to the screening visit.\n* Participant was receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study.\n* Participant was using or had used recreational cannabis, medicinal cannabis, or cannabinoid medications (including Sativex) within one month prior to study entry and unwilling to abstain for the duration of the study.\n* Participant had any known or suspected history of alcohol or substance abuse, or epilepsy or recurrent seizures.\n* Participant had any known or suspected history of major depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression, in the opinion of the investigator).\n* Participant had clinically significant cardiac, renal, or hepatic impairment, in the opinion of the investigator.\n* Participant had known history of Hepatitis B or C.\n* Participant had genetic dyslipidaemia, in the opinion of the Investigator.\n* Participant had any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, influence the result of the study, or affect the participant's ability to participate in the study.\n* Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s).\n* Participant had presence of any metal implants.\n* Participant had any known or suspected history of claustrophobia.\n* Female participants of child bearing potential not able or willing to use effective contraception for the duration of the study and for three months thereafter, or male participants whose partner was of child bearing potential, who was not willing to ensure that they or their partner would use effective contraception during the study and for three months thereafter.\n* Female participant who was pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.\n* Participants who weighed \\>150 kilograms (kg).\n* Participant had any abnormalities following a physical examination that, in the opinion of the investigator, prevented the participant from safe participation in the study.\n* Participant was unwilling to abstain from donation of blood during the study.\n* Participant had planned travel outside the country of residence during the study.\n* Participant had previously enrolled into this study."}, 'identificationModule': {'nctId': 'NCT01284634', 'briefTitle': 'Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease', 'organization': {'class': 'UNKNOWN', 'fullName': 'GWResearch'}, 'officialTitle': 'A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study To Assess The Effect Of Cannabidiol (CBD) On Liver Fat Levels In Subjects With Fatty Liver Disease.', 'orgStudyIdInfo': {'id': 'GWMD09112'}, 'secondaryIdInfos': [{'id': '2009-017080-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GWP42003 200 milligrams (mg)/day Dose', 'description': 'Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'interventionNames': ['Drug: GWP42003 200 mg/day Dose']}, {'type': 'EXPERIMENTAL', 'label': 'GWP42003 400 mg/day Dose', 'description': 'Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'interventionNames': ['Drug: GWP42003 400 mg/day Dose']}, {'type': 'EXPERIMENTAL', 'label': 'GWP42003 800 mg/day Dose', 'description': 'Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]).', 'interventionNames': ['Drug: GWP42003 800 mg/day Dose']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \\[fasted\\] and the second was 30 minutes before the evening meal \\[typically 12 hours apart\\]). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GWP42003 200 mg/day Dose', 'type': 'DRUG', 'otherNames': ['Cannabidiol, CBD'], 'description': 'GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).', 'armGroupLabels': ['GWP42003 200 milligrams (mg)/day Dose']}, {'name': 'GWP42003 400 mg/day Dose', 'type': 'DRUG', 'otherNames': ['Cannabidiol, CBD'], 'description': 'GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).', 'armGroupLabels': ['GWP42003 400 mg/day Dose']}, {'name': 'GWP42003 800 mg/day Dose', 'type': 'DRUG', 'otherNames': ['Cannabidiol, CBD'], 'description': 'GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).', 'armGroupLabels': ['GWP42003 800 mg/day Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo control'], 'description': 'Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W120NN', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M32 0UT', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GW Research Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}