Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-09 @ 9:05 PM
Study NCT ID:
NCT00949702
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2009-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077484', 'term': 'Vemurafenib'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening through 6 months after the last patient enrolled', 'eventGroups': [{'id': 'EG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.', 'otherNumAtRisk': 132, 'otherNumAffected': 131, 'seriousNumAtRisk': 132, 'seriousNumAffected': 67}], 'otherEvents': [{'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 68}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PHOTOSENSITIVITY REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 65}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 47}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 40}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SKIN PAPILLOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPERKERATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH MACULO-PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ACTINIC KERATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'KERATOSIS PILARIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PALMAR-PLANTAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ERYTHRODYSAESTHESIA SYNDROME ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SKIN EXFOLIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SKIN LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'JOINT SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SUNBURN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LYMPHOCYTE COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SEBORRHOEIC KERATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FOLLICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MELANOCYTIC NAEVUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 28}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'KERATOACANTHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'OESOPHAGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BREAST CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PSEUDOMONAS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SALMONELLOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SKIN INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FACIAL PALSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BILIRUBIN CONJUGATED INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEPATIC CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'TUMOUR LYSIS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'EXFOLIATIVE RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH VESICULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DELIRIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RETINAL VEIN OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LEFT LUNG GROUND GLASS OPACITIES-PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '43.4', 'upperLimit': '61.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \\<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '45.7', 'upperLimit': '63.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \\<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': 'Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'comment': 'The upper limit of the confidence interval was not estimable because a large percentage of patients (57%) were progression-free at the data cutoff date and had censored data.', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': 'Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and the upper limit of the confidence interval were not estimable because a large percentage of patients (69%) were alive at the data cutoff date.', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': "Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'title': 'Improvement in performance status', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '90.0'}]}]}, {'title': 'Improvement in oxygen saturation requirement', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}, {'title': 'Decrease in use of narcotic pain analgesics', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment through September 27, 2010', 'description': "Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value \\< 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.73', 'spread': '21.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 8 hours post-dose on Day 15 of Cycle 1', 'description': 'Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.'}, {'type': 'SECONDARY', 'title': 'Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '380.16', 'spread': '143.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 8 hours post-dose on Day 15 of Cycle 1', 'description': 'Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.', 'unitOfMeasure': 'μg⋅h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.'}, {'type': 'SECONDARY', 'title': 'Vemurafenib Plasma Levels at Various Treatment Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'title': 'Pre-dose Cycle 1 Day 15, n=108', 'categories': [{'measurements': [{'value': '47.55', 'spread': '23.14', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 2 Day 1, n=122', 'categories': [{'measurements': [{'value': '41.12', 'spread': '23.39', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 3 Day 1, n=109', 'categories': [{'measurements': [{'value': '45.20', 'spread': '21.33', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 4 Day 1, n=109', 'categories': [{'measurements': [{'value': '50.31', 'spread': '19.52', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 6 Day 1, n=96', 'categories': [{'measurements': [{'value': '50.38', 'spread': '19.54', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 8 Day 1, n=71', 'categories': [{'measurements': [{'value': '50.42', 'spread': '22.06', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 10 Day 1, n=50', 'categories': [{'measurements': [{'value': '50.78', 'spread': '20.19', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose Cycle 2 Day 22, n=93', 'categories': [{'measurements': [{'value': '48.38', 'spread': '20.00', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose Cycle 3 Day 43, n=78', 'categories': [{'measurements': [{'value': '50.79', 'spread': '19.20', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose Cycle 4 Day 1, n=75', 'categories': [{'measurements': [{'value': '55.76', 'spread': '20.57', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose Cycle 6 Day 1, n=58', 'categories': [{'measurements': [{'value': '58.92', 'spread': '20.12', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose Cycle 8 Day 1, n=43', 'categories': [{'measurements': [{'value': '58.95', 'spread': '20.98', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose Cycle 10 Day 1, n=27', 'categories': [{'measurements': [{'value': '63.27', 'spread': '21.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1', 'description': 'Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'title': 'Cycle 1 Day 15 at 2 hours post-dose, n=109', 'categories': [{'measurements': [{'value': '12.8', 'comment': 'This is a one-sided confidence interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '14.9'}]}]}, {'title': 'Cycle 6 Day 1 at pre-dose, n=85', 'categories': [{'measurements': [{'value': '15.1', 'comment': 'This is a one-sided confidence interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '17.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1', 'description': 'Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)\\^β (β=mean \\[calculated separately for males and females\\] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.', 'unitOfMeasure': 'ms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vemurafenib 960 mg', 'description': 'Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '14.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2009-07-28', 'resultsFirstSubmitDate': '2011-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-11-17', 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \\<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \\<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.'}, {'measure': 'Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.'}, {'measure': 'Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.'}, {'measure': 'Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.'}, {'measure': 'Overall Survival', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.'}, {'measure': "Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline", 'timeFrame': 'From first treatment through September 27, 2010', 'description': "Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value \\< 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported."}, {'measure': 'Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1', 'timeFrame': 'Pre-dose to 8 hours post-dose on Day 15 of Cycle 1', 'description': 'Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).'}, {'measure': 'Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1', 'timeFrame': 'Pre-dose to 8 hours post-dose on Day 15 of Cycle 1', 'description': 'Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.'}, {'measure': 'Vemurafenib Plasma Levels at Various Treatment Cycles', 'timeFrame': 'Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1', 'description': 'Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.'}, {'measure': 'Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)', 'timeFrame': 'Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1', 'description': 'Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)\\^β (β=mean \\[calculated separately for males and females\\] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.'}, {'measure': 'Percentage of Patients With Adverse Event', 'timeFrame': 'From first treatment through September 27, 2010', 'description': 'The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).'}]}, 'conditionsModule': {'conditions': ['Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '32746839', 'type': 'DERIVED', 'citation': 'Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.'}, {'pmid': '24983357', 'type': 'DERIVED', 'citation': 'Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.'}, {'pmid': '23457002', 'type': 'DERIVED', 'citation': 'Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1.'}, {'pmid': '22356324', 'type': 'DERIVED', 'citation': 'Sosman JA, Kim KB, Schuchter L, Gonzalez R, Pavlick AC, Weber JS, McArthur GA, Hutson TE, Moschos SJ, Flaherty KT, Hersey P, Kefford R, Lawrence D, Puzanov I, Lewis KD, Amaravadi RK, Chmielowski B, Lawrence HJ, Shyr Y, Ye F, Li J, Nolop KB, Lee RJ, Joe AK, Ribas A. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med. 2012 Feb 23;366(8):707-14. doi: 10.1056/NEJMoa1112302.'}, {'pmid': '22256804', 'type': 'DERIVED', 'citation': 'Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15. doi: 10.1056/NEJMoa1105358.'}]}, 'descriptionModule': {'briefSummary': 'This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \\[RG7204; PLEXXIKON: PLX4032\\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \\<100 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>/=18 years of age\n* histologically confirmed metastatic melanoma (Stage IV, AJCC)\n* patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)\n* BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)\n* measurable disease by RECIST criteria\n* negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion\n\nExclusion Criteria:\n\n* active CNS metastases on CT/MRI within 28 days prior to enrollment\n* history of or known carcinomatous meningitis\n* previous treatment with BRAF (sorafenib allowed) or MEK inhibitor\n* cardiac dysrhythmias \\>2 NCI CTCAE or treatment with drugs with dysrhythmic potential\n* uncontrolled hypertension(\\>150/100mmHg) despite optimal medical therapy\n* infectious disease including HIV, HBV and HCV'}, 'identificationModule': {'nctId': 'NCT00949702', 'briefTitle': 'A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'NP22657'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'interventionNames': ['Drug: vemurafenib']}], 'interventions': [{'name': 'vemurafenib', 'type': 'DRUG', 'description': '960 mg b.i.d. continuous oral dosing', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6984', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA - School of Medicine; Division of Hematology/Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital;Hematology/ Oncology', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Inst. ; Dept. of Medical Oncology', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Ctr', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2298', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle; Melanoma Clinic', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital; Medical Oncology and Pallative Care', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter Maccallum Cancer Institute; Medical Oncology', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}