Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT03713320
Status:
TERMINATED
Last Update Posted:
2022-04-08
First Post:
2018-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721492', 'term': 'cobomarsen'}, {'id': 'D000077337', 'term': 'Vorinostat'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@viridiantherapeutics.com', 'phone': '720-722-5917', 'title': 'Regulatory Affairs', 'organization': 'Viridian Therapeutics (formerly miRagen Therapeutics)'}, 'certainAgreement': {'otherDetails': 'Investigators in this study may present or publish study results in scientific journals or other scholarly media without prior written approval after the following conditions have been met:\n\n* Results of study have been publicly disclosed by or with the consent of the sponsor\n* Investigator has complied with the Clinical Trial Agreement and requests from the sponsor to delete confidential information (other than study results)\n* Study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy. Because the study was terminated early, enrollment was ended at 37 participants instead of the initially planned 126 participants, and a planned interim analysis based on these 37 participants was the only analysis performed for the study. The study duration was also shortened from an estimated 36 months to 20 months overall.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.", 'eventGroups': [{'id': 'EG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cobomarsen (Crossover)', 'description': 'For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood alkaline phosphatase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Crystal urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 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'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 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'numAtRisk': 19, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin plaque', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin weeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Superinfection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Superinfection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tumour flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tumour inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urine abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urine albumin/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Superinfection of Skin Lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.9539', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the treatment groups is based on a Cochran-Mantel-Haenzel test controlling for the number of tumors at screening (at least one tumor at screening versus no tumors at screening) and number of prognostic factors (0-1 versus 2 prognostic factors). Prognostic factors include age at diagnosis \\> 60 years and lactate dehydrogenase level \\> upper limit of normal at diagnosis. Number of subjects achieving ORR4 and exact binomial (Clopper-Pearson) confidence intervals are presented.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5. The median could not be calculated from the available data because there were an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '9.26', 'upperLimit': 'NA'}, {'value': '6.01', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '8.90'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hazard ratio (cobomarsen/vorinostat) and p-value comparing the treatment groups is based on a Cox proportional hazards model. A hazard ratio \\< 1 favors cobomarsen over vorinostat.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment \\[cobomarsen or vorinostat\\] and had at least one post-baseline assessment). Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Percentage of subjects with a complete response in the skin based on mSWAT', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median could not be calculated from the available data.', 'groupId': 'OG000', 'lowerLimit': '9.26', 'upperLimit': 'NA'}, {'value': '6.01', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '8.90'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time from date of randomization until the earliest date of confirmed progression', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Time to Maximal Effect in mSWAT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time to greatest improvement in mSWAT score', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with improvement in mSWAT score'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after first dose', 'description': 'Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months after first dose', 'description': 'Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Time to ≥ 50% Improvement in mSWAT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time from date of randomization until ≥ 50% improvement in mSWAT score', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who achieved an objective response in skin (≥ 50% improvement in mSWAT)'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was defined as the smallest observed survival time for which the value of the Kaplan-Meier estimated survival function was less than or equal to 0.5. The median and 95% Confidence Interval could not be calculated from the available data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.85', 'comment': 'Median was defined as the smallest observed survival time for which the value of the Kaplan-Meier estimated survival function was less than or equal to 0.5. The 95% Confidence Interval could not be calculated from the available data.', 'groupId': 'OG001', 'lowerLimit': '6.60', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who achieved an objective response in skin (≥ 50% improvement in mSWAT)'}, {'type': 'SECONDARY', 'title': 'Pruritus Medication Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Change from baseline in number of pruritus medications taken per subject', 'unitOfMeasure': 'Number of pruritus medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with any predose or postdose pruritus medications, including subjects with no predose medications and at least one postdose medication'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '7.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 1.92, 6, 24 and 48 hours post-dose after the first dose', 'description': 'Peak plasma concentration (Cmax) of cobomarsen after first dose', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included those randomized to cobomarsen treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.34', 'spread': '3.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 1.92 and 6 hours post-dose after the Week 5 dose', 'description': 'Peak plasma concentration (Cmax) of cobomarsen after fourth dose (Week 5)', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included those randomized to cobomarsen treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '6.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 1.92 and 6 hours post-dose after the Week 5 dose', 'description': 'Area under the curve (AUClast) for cobomarsen plasma concentration versus time curve after the fourth (Week 5) dose', 'unitOfMeasure': 'µg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included those randomized to cobomarsen treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Anti-drug Antibody Generation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'OG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}], 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Number of participants who develop antibodies to cobomarsen during treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated for business reasons. No data were collected to evaluate this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cobomarsen (Randomized)', 'description': 'Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}, {'id': 'FG001', 'title': 'Vorinostat (Randomized)', 'description': 'Vorinostat (400 mg \\[4x100 mg capsules\\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\\> upper limit of normal \\[ULN\\]) or bilirubin (\\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines.\n\nVorinostat: 100 mg capsules'}, {'id': 'FG002', 'title': 'Cobomarsen (Crossover)', 'description': 'For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion'}], 'periods': [{'title': 'Randomized Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Cobomarsen Crossover Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision to terminate trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cobomarsen', 'description': 'Cobomarsen: At least weekly doses of cobomarsen (282 mg) throughout study treatment period'}, {'id': 'BG001', 'title': 'Vorinostat', 'description': 'Vorinostat: Daily doses of vorinostat throughout study treatment period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Skin tumor at screening', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'No skin tumor at screening', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lactate dehydrogenase (LDH) is greater than upper limit normal (ULN) at diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'LDH is not greater than ULN at diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'LDH not reported at diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-10', 'size': 1673258, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-03T19:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2018-10-17', 'resultsFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-15', 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose', 'timeFrame': '1, 1.92, 6, 24 and 48 hours post-dose after the first dose', 'description': 'Peak plasma concentration (Cmax) of cobomarsen after first dose'}, {'measure': 'Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5', 'timeFrame': '1, 1.92 and 6 hours post-dose after the Week 5 dose', 'description': 'Peak plasma concentration (Cmax) of cobomarsen after fourth dose (Week 5)'}, {'measure': 'Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5', 'timeFrame': '1, 1.92 and 6 hours post-dose after the Week 5 dose', 'description': 'Area under the curve (AUClast) for cobomarsen plasma concentration versus time curve after the fourth (Week 5) dose'}, {'measure': 'Number of Participants With Anti-drug Antibody Generation', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Number of participants who develop antibodies to cobomarsen during treatment'}], 'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)', 'timeFrame': 'Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.'}, {'measure': 'Complete Response Rate', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Percentage of subjects with a complete response in the skin based on mSWAT'}, {'measure': 'Time to Progression', 'timeFrame': 'Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time from date of randomization until the earliest date of confirmed progression'}, {'measure': 'Time to Maximal Effect in mSWAT', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time to greatest improvement in mSWAT score'}, {'measure': 'Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration'}, {'measure': 'Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days', 'timeFrame': '28 days after first dose', 'description': 'Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose'}, {'measure': 'Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months', 'timeFrame': '4 months after first dose', 'description': 'Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose'}, {'measure': 'Time to ≥ 50% Improvement in mSWAT', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Time from date of randomization until ≥ 50% improvement in mSWAT score'}, {'measure': 'Duration of Response in Skin', 'timeFrame': 'Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)'}, {'measure': 'Pruritus Medication Utilization', 'timeFrame': 'Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months', 'description': 'Change from baseline in number of pruritus medications taken per subject'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SOLAR', 'Cutaneous T-cell Lymphoma', 'CTCL', 'Mycosis Fungoides', 'Lymphoma', 'Lymphoma, T-cell', 'Lymphoma, T-cell, cutaneous', 'Lymphoma, Non-Hodgkin', 'Lymphoproliferative Disorders', 'Lymphatic Diseases', 'Immunoproliferative Disorders', 'Immune System Diseases', 'Neoplasms', 'MicroRNAs', 'Vorinostat', 'Histone Deacetylase Inhibitors'], 'conditions': ['Cutaneous T-Cell Lymphoma/Mycosis Fungoides']}, 'referencesModule': {'references': [{'pmid': '33085815', 'type': 'DERIVED', 'citation': 'Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7.'}, {'pmid': '32632956', 'type': 'DERIVED', 'citation': 'Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.'}]}, 'descriptionModule': {'briefSummary': "The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.\n\nParticipants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.\n\nParticipants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.", 'detailedDescription': "Study Design:\n\nSubjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. An interim analysis will be conducted after approximately 40 subjects have been followed for a minimum of approximately 6 months. Enrollment will be suspended until the completion of the interim analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Biopsy-proven CTCL, MF subtype\n* Clinical stage IB, II, or III, with staging based on screening assessments\n* Minimum mSWAT score of 10 at screening\n* Receipt of at least one prior therapy for CTCL\n\nKey Exclusion Criteria:\n\n* Previous enrollment in a cobomarsen study\n* Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor\n* Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening\n* Evidence of large cell transformation\n* Lymph node involvement at screening, unless radiologically or histologically confirmed to be nonmalignant\n* Visceral involvement related to MF at screening'}, 'identificationModule': {'nctId': 'NCT03713320', 'acronym': 'SOLAR', 'briefTitle': 'SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides', 'organization': {'class': 'INDUSTRY', 'fullName': 'miRagen Therapeutics, Inc.'}, 'officialTitle': 'SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype', 'orgStudyIdInfo': {'id': 'MRG106-11-201'}, 'secondaryIdInfos': [{'id': '2018-000727-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cobomarsen', 'description': 'Cobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter', 'interventionNames': ['Drug: Cobomarsen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vorinostat', 'description': 'Vorinostat will be administered orally at a dose of 400 mg (four 100-mg capsules) once daily with food, at approximately the same time each day.', 'interventionNames': ['Drug: Vorinostat']}], 'interventions': [{'name': 'Cobomarsen', 'type': 'DRUG', 'otherNames': ['MRG-106'], 'description': 'At least weekly doses of cobomarsen (282 mg) throughout study treatment period', 'armGroupLabels': ['Cobomarsen']}, {'name': 'Vorinostat', 'type': 'DRUG', 'description': 'Daily doses of vorinostat throughout study treatment period', 'armGroupLabels': ['Vorinostat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center at University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Smilow Cancer Hospital at Yale-New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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