Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-02 @ 8:04 AM
Study NCT ID:
NCT01256359
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Docetaxel With or Without AZD6244 in 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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C517975', 'term': 'AZD 6244'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.middleton@oncology.ox.ac.uk', 'phone': '+44 (0)1865 617331', 'title': 'Professor Mark Middleton', 'organization': 'University of Oxford'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '170 days', 'description': 'Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 35, 'seriousNumAtRisk': 41, 'deathsNumAffected': 26, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 40, 'seriousNumAtRisk': 42, 'deathsNumAffected': 28, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Febrile Neutropenia', 'notes': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Blurred Vision', 'notes': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry Eye', 'notes': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Floaters', 'notes': 'Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Watering Eyes', 'notes': 'Watering Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nausea', 'notes': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Constipation', 'notes': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Flatulence', 'notes': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspepsia', 'notes': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diarrhoea', 'notes': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 81, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 29, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry Mouth', 'notes': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'notes': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Abdominal Pain', 'notes': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucositis Oral', 'notes': 'Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 35, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Localized Edema', 'notes': 'Localized Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fatigue', 'notes': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 58, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 60, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fever', 'notes': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Allergic Reaction', 'notes': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nail Infection', 'notes': 'Nail Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Upper Respiratory Infection', 'notes': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucosal Infection', 'notes': 'Mucosal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bronchial Infection', 'notes': 'Bronchial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Wound Infection', 'notes': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urinary Tract Infection', 'notes': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Other Infection', 'notes': 'Other Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin Infection', 'notes': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Neutrophil Count Decreased', 'notes': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Platelet Count Decreased', 'notes': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypoalbuminemia', 'notes': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anorexia', 'notes': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Arthralgia', 'notes': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Myalgia', 'notes': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pain - Other', 'notes': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 43, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Peripheral Sensory Neuropathy', 'notes': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dizziness', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysgeusia', 'notes': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Depression', 'notes': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Insomnia', 'notes': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspnea', 'notes': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Epistaxis', 'notes': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Cough', 'notes': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Other Rash', 'notes': 'Other Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nail Ridging', 'notes': 'Nail Ridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rash Acneiform', 'notes': 'Rash Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 54, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry Skin', 'notes': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alopecia', 'notes': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Palmar-Plantar Erythrodysesthesia Syndrome', 'notes': 'Palmar-Plantar Erythrodysesthesia Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Periorbital Edema', 'notes': 'Periorbital Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Flushing', 'notes': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Thromboembolic Event', 'notes': 'Thromboembolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Blood Potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dandruff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diverticular Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gamma-Glutamyltransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gastrooeophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Micturition Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucosal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Postmenopausal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Postnasal Drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Seborrhoeic Keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin Exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tongue Coated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tooth Discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tooth Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vulvovaginal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Retinal Vascular Disorder', 'notes': 'Retinal Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gastric Haemorrhage', 'notes': 'Gastric Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'notes': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diarrhoea', 'notes': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Abdominal Pain', 'notes': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fever', 'notes': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Allergic Reaction', 'notes': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Other - Source Unknown', 'notes': 'Other - Source Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Enterocolitis Infectious', 'notes': 'Enterocolitis Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin Infection', 'notes': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Lung Infection', 'notes': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Upper Respiratory Infection', 'notes': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Sepsis', 'notes': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Neutrophil Count Decreased', 'notes': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Arthralgia', 'notes': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Muscle Weakness Lower Limb', 'notes': 'Muscle Weakness Lower Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Presyncope', 'notes': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspnea', 'notes': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.23', 'groupId': 'OG000', 'lowerLimit': '3.63', 'upperLimit': '6.90'}, {'value': '3.93', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '4.16'}]}]}], 'analyses': [{'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.753', 'ciLowerLimit': '0.498', 'ciUpperLimit': '1.138', 'pValueComment': 'p value \\< 0.1 one-sided considered to be significant.', 'estimateComment': 'HR is Adjusted for M status, performance status', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.723', 'ciLowerLimit': '0.465', 'ciUpperLimit': '1.123', 'estimateComment': 'This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status', 'groupDescription': 'This is a sensitivity analysis of the primary outcome. This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3016', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This analysis assesses if allowing for interval censoring is consistent with the primary outcome results.', 'groupDescription': 'This is a sensitivity analysis, including all 83 randomised patients. Patients are assessed periodically for the response (progression), the time when the event occurred is not directly observed but is known to take place within some time interval. Progression is known only to have occurred at some time between visits, the exact time is not known. We carried out interval censored analysis to demonstrate if allowing for interval censoring gives a different interpretation of the primary outcome.', 'statisticalMethod': 'Generalised log-rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalised log-rank taking into account interval censoring, analysed using SAS package version 9.2. Method by Zhao and Sun, 2004'}, {'pValue': '0.305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.348', 'ciLowerLimit': '0.602', 'ciUpperLimit': '3.016', 'estimateComment': 'Adjusted for centre', 'groupDescription': 'Sensitivity analysis adjusting for centre. All 83 randomised patients were included in analysis. Centres were the three biggest recruiters and all other 13 centres are combined.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST (v1.1) criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis was intention to treat and involved all patients who were randomly assigned.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival Rate at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '53'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '38'}]}]}], 'analyses': [{'pValue': '0.187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '14', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '31.4', 'estimateComment': 'This is the estimated difference in PFS rate i.e. % difference between arms', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'PFS at 6 months is defined as the percentage progression free survival at 6 months from the PFS Kaplan Meier graph. This would allow all patients randomised to be included. progression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat i.e. all randomised patients'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.467', 'upperLimit': '12.9'}, {'value': '11.367', 'groupId': 'OG001', 'lowerLimit': '7.467', 'upperLimit': '18'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.373', 'ciLowerLimit': '0.797', 'ciUpperLimit': '2.369', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value \\< 0.1 one-sided considered to be significant.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'This is defined as the time from randomisation to death (event) or time from randomisation to date last known alive (censored time).', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Not applicable', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Objective response rate calculated as number of patients with CR or PR over all patients randomised.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Objective response rate calculated as number of patients with Complete Response (CR) or Partial response (PR) over all patients randomised. The numerator of the objective response rate is the number of patients achieving a CR or PR. The denominator is all patients randomised. RECIST(v1.1) criteria was used for assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Overall Survival Results - Post Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.47', 'upperLimit': '12.53'}, {'value': '11.37', 'groupId': 'OG001', 'lowerLimit': '8.67', 'upperLimit': '16.03'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.15', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.84', 'groupDescription': 'Analysis adjusted for with Mstatus and Performance Score', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'OS analysis was carried out at the final analysis time point on data taken on 01Oct2012. Another data extraction was taken on 05Mar2013 in order to carry out posthoc analyses, OS was analysed again on this data.\n\nOS is time from randomisation to death (event) or time from randomisation to date last known alive (censored time).', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '36.6'}, {'value': '36.3', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '36.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - temperature.', 'unitOfMeasure': 'Degree celsius', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '88'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - pulse rate.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '121', 'upperLimit': '144'}, {'value': '130', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - systolic blood pressure.', 'unitOfMeasure': 'Mg mercury', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Whole study'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '90'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - diastolic blood pressure.', 'unitOfMeasure': 'Mg mercury', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.425', 'groupId': 'OG000', 'lowerLimit': '80.95', 'upperLimit': '99.1'}, {'value': '83.45', 'groupId': 'OG001', 'lowerLimit': '68.2', 'upperLimit': '96.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Weight.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Haematology - Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '13.6'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '13.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Haematology - haemoglobin.', 'unitOfMeasure': 'grams per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Whole study'}, {'type': 'SECONDARY', 'title': 'Haematology - White Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.75', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '11.2'}, {'value': '8.405', 'groupId': 'OG001', 'lowerLimit': '4.84', 'upperLimit': '13.295'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are median values across all time-points for all patients in that arm.', 'description': 'Haematology - white cell count.', 'unitOfMeasure': '10^9 cells litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Haematology - Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '2.64', 'upperLimit': '8.82'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '2.85', 'upperLimit': '11.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Haematology - neutrophils.', 'unitOfMeasure': '10^9 cells litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Haematology - Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000', 'lowerLimit': '223', 'upperLimit': '324'}, {'value': '290.5', 'groupId': 'OG001', 'lowerLimit': '229.5', 'upperLimit': '363'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Haematology - platelets.', 'unitOfMeasure': '10^9 cells litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.245', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.43'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - phosphate.', 'unitOfMeasure': 'mmol per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '2.36'}, {'value': '2.34', 'groupId': 'OG001', 'lowerLimit': '2.26', 'upperLimit': '2.43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - calcium.', 'unitOfMeasure': 'mmol per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000', 'lowerLimit': '137', 'upperLimit': '141'}, {'value': '139', 'groupId': 'OG001', 'lowerLimit': '137', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - sodium.', 'unitOfMeasure': 'mmol per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4.54'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - potassium.', 'unitOfMeasure': 'mmol per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '6.6'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - urea.', 'unitOfMeasure': 'mmol per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - bilirubin.', 'unitOfMeasure': 'umol per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '147'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '153'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - alkaline phosphatase.', 'unitOfMeasure': 'IU per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '47'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - ALT.', 'unitOfMeasure': 'IU per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '41'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - AST.', 'unitOfMeasure': 'IU per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '41'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - albumin.', 'unitOfMeasure': 'grams per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - GGT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '73'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - GGT.', 'unitOfMeasure': 'grams per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '71'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - total protein.', 'unitOfMeasure': 'grams per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - LDH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000', 'lowerLimit': '243', 'upperLimit': '491'}, {'value': '386.5', 'groupId': 'OG001', 'lowerLimit': '233', 'upperLimit': '499'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - LDH.', 'unitOfMeasure': 'Units per litre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Biochemistry - Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '113.6', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '139.26'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '83.5', 'upperLimit': '119.18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - creatinine.', 'unitOfMeasure': 'milligrams per decalitre', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Assessment - General Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical assessment - general appearance.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - skin.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Head and Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - head and neck.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Chest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - chest.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Cardiovascular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - cardiovascular.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Abdomen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - abdomen.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Lymph Nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - lymph nodes.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Extremities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - extremities.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Musculoskeletal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - musculoskeletal.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Neurological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - neurological.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Physical Exam - Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - other.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'ECG - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Not evalauated', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'ECG - pre-dose.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'ECG - Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'ECG - post-dose.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Data points', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}, {'title': 'Abnormal', 'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}, {'title': 'Not evaluated', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Urinalysis.', 'unitOfMeasure': 'Data points', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data points', 'denomUnitsSelected': 'Data points', 'populationDescription': 'Intention to treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Progression Free Survival: Sensitivity Analysis 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.233'}, {'value': '3.333', 'groupId': 'OG001', 'lowerLimit': '2.067', 'upperLimit': '4.167'}]}]}], 'analyses': [{'pValue': '0.468', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.022', 'ciLowerLimit': '0.649', 'ciUpperLimit': '1.612', 'estimateComment': 'Analysis Adjusted for M status, performance status', 'groupDescription': 'This is a sensitivity analysis of the primary outcome.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Same as for primary analysis. This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST v1.1 criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a sensitivity analysis of the primary outcome and includes randomised patients that had CT scans as per protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Progression Free Survival- Per Protocol Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.033'}, {'value': '4.067', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.721', 'ciLowerLimit': '0.468', 'ciUpperLimit': '1.109', 'estimateComment': 'Analysis was adjusted for mstatus, performance status', 'groupDescription': 'This is the per-protocol analysis of the primary outcome.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Same as for primary analysis. This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST v1.1. criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population, this is the primary analysis population excluding four patients who did not start treatment and two patients who were later found to be ineligible.'}, {'type': 'POST_HOC', 'title': 'Progression Free Survival: in Patients With NRAS Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '7.13'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.824', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.53', 'pValueComment': 'p-value is for the interaction term', 'estimateComment': 'HRs (95% CI) between treatment groups are given for Wild type and NRAS mutated separately. The above HR is for WT.', 'groupDescription': 'Model with interaction term between NRAS status and treatment group and stratification variables', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Outcome is time from randomisation to progression or death in subset of patients with NRAS mutational data available and in the per-protocol population.\n\nprogression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria.\n\nNRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population and only those with NRAS status'}, {'type': 'POST_HOC', 'title': 'Overall Survival in Patients With NRAS Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.07', 'groupId': 'OG000', 'lowerLimit': '8.47', 'upperLimit': '12.9'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '18'}]}]}], 'analyses': [{'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.16', 'ciUpperLimit': '1.60', 'pValueComment': 'p-value is for interaction term.', 'estimateComment': 'HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.\n\nHazard ratios (95%CI) given above are for NRAS WT patients.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes interaction term between NRAS status and treatment group and stratification variables'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '0.73', 'ciUpperLimit': '5.33', 'estimateComment': 'HR for NRAS mutated patients', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Outcome is time from randomisation to death in subset of patients with NRAS mutational data available and in the per-protocol population.\n\nNRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population and only those with NRAS data'}, {'type': 'POST_HOC', 'title': 'Objective Response Rate in Patients With WT NRAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Best overall response as reported for evaluable/measurable scans including target, non-target and new lesions. Response assessed using RECIST(v1.1) criteria.\n\nData from Mar2013 which was post final data lock', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population and only those with NRAS status- wild type'}, {'type': 'POST_HOC', 'title': 'Overall Survival Results - Post Final Analysis- Per-protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.53', 'upperLimit': '12.53'}, {'value': '11.77', 'groupId': 'OG001', 'lowerLimit': '8.67', 'upperLimit': '16.03'}]}]}], 'analyses': [{'pValue': '0.348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.12', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.87', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Adjusted for with Mstatus and Performance Score'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'OS analysis was carried out at the final analysis time point on data taken on 01Oct2012. Another data extraction was taken on 05Mar2013 in order to carry out posthoc analyses, OS was analysed again on this data.\n\nOS is time from randomisation to death (event) or time from randomisation to date last known alive (censored time).', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population.'}, {'type': 'POST_HOC', 'title': 'Progression Free Survival: in Patients With NRAS Data- Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '7.27'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '4.27'}]}]}], 'analyses': [{'pValue': '0.797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.61', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.58', 'pValueComment': 'p-value is for interaction term.', 'estimateComment': 'HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.\n\nHazard ratios (95%CI) given above are for NRAS WT patients.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes interaction term between NRAS status and treatment group and stratification variables'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.350', 'ciUpperLimit': '1.45', 'estimateComment': 'HR for NRAS mutated patients', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Outcome is time from randomisation to progression or death in subset of patients with NRAS mutational data available and in the per-protocol population and excluding patients found to have BRAF mutation on retesting (the inclusion criteria for the trial is those with wildtype BRAF).\n\nprogression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria.\n\nNRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population and only patients with NRAS mutational data and excluding patients found to have BRAF mutation on retesting'}, {'type': 'POST_HOC', 'title': 'Overall Survival in Patients With NRAS Data- Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.07', 'groupId': 'OG000', 'lowerLimit': '8.47', 'upperLimit': '12.9'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '10.43', 'upperLimit': '18'}]}]}], 'analyses': [{'pValue': '0.120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.97', 'pValueComment': 'Model includes interaction term between NRAS status and treatment group and stratification variables. p-value is for interaction term.', 'estimateComment': 'HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.\n\nHazard ratios (95%CI) given above are for NRAS WT patients.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '0.73', 'ciUpperLimit': '5.38', 'estimateComment': 'HR for NRAS mutated patients', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Outcome is time from randomisation to death in subset of patients with NRAS mutational data available and in the per-protocol population and excluding patients found to have BRAF mutation on retesting (the inclusion criteria for the trial is those with wildtype BRAF).\n\nNRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population, including only patients with NRAS data and excluding patients found to have BRAF mutation on retesting'}, {'type': 'POST_HOC', 'title': 'Objective Response Rate in Patients With Mutated NRAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'OG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Partial response', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stable disease', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Not applicable', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Best overall response as reported for evaluable/measurable scans including target, non-target and new lesions. Response assessed using RECIST(v1.1) criteria.\n\nData from Mar2013 which was post final data lock', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population and only those with NRAS status=mutated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'FG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'comment': 'Numbers completed here are those who started treatment i.e. only excludes those who received no allocated intervention. Treatment duration is flexible, there is not mark for treatment completion, patients can keep receiving cycles of treatment up to 6 cycles.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Randomised, later found to be ineligible and did not start treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomised and found to be too unwell to start treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment of 83 participants from 16 centres (hospitals) took place between October 2010 and May 2012. Participants attended clinic visits according to the protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244\n\nDocetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.'}, {'id': 'BG001', 'title': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244\n\nDocetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.5', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': 'M1c', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'M0 or M1a or M1b', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'M0 = No distant metastases M1a = Distant skin, subcutaneous, or nodal metastases (normal serum LDH) M1b = Lung metastases (normal serum LDH) M1c = All other visceral metastases (normal serum LDH); Any distant metastasis (elevated LDH)', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0 = Fully active, able to carry out all on all pre-disease performance without restriction. 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work. 2 = Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 = Capable of only limited self-care. Confined to bed or chair more than 50% of waking hours. 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair.', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'No, but smoked in the past', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Never smoked', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Physical examination', 'classes': [{'title': 'General appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'HEENT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Chest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Cardiovascular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Abdomen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Lymph nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Extremities/back', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Musculoskeletal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Neurological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other body system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'n =Freq of pts with abnormal results. Physical examination undertaken in line with established clinical practice, adhering specifically to the standards required as part of UK medical training. Outputs from such an examination are diverse and not usually, in and of themselves, definitive. Rather they point to potential system specific abnormalities evaluated further so as to identify the issue, its severity and relationship to IMPs.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Not all patients were evaluated for each abnormality'}, {'title': 'Vital Signs: temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'BG000', 'lowerLimit': '35.2', 'upperLimit': '37.3'}, {'value': '36.5', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '37.4'}, {'value': '36.4', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '37.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'degrees C', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Totals are patients with available data'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '1.70', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '1.72', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88.4', 'spread': '19.0', 'groupId': 'BG000'}, {'value': '83.0', 'spread': '19.5', 'groupId': 'BG001'}, {'value': '85.7', 'spread': '19.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.022', 'spread': '0.232', 'groupId': 'BG000'}, {'value': '1.939', 'spread': '0.260', 'groupId': 'BG001'}, {'value': '1.980', 'spread': '0.249', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry', 'classes': [{'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '93'}, {'value': '22', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '54'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '93'}]}]}, {'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '104'}, {'value': '22', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '58'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '104'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Numbers analysed are available data'}, {'title': 'LDH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Above Upper limit normal', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Below Upper limit normal', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Haematology', 'classes': [{'title': 'White cell count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '15'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '13'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '19'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '17'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '259', 'groupId': 'BG000', 'lowerLimit': '147', 'upperLimit': '681'}, {'value': '255', 'groupId': 'BG001', 'lowerLimit': '177', 'upperLimit': '754'}, {'value': '259', 'groupId': 'BG002', 'lowerLimit': '147', 'upperLimit': '754'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells x 10^9/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Numbers analysed are those with available data'}, {'title': 'Abnormal ECG', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'N=abnormal electrocardiogram', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed represents the number of participants evaluated for this Baseline Measure'}, {'title': 'Abnormal Urinalysis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'N= abnormal urinalysis', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed represents the number of participants evaluated for this Baseline Measure'}, {'title': 'Conmeds', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of patients reporting taking con meds at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Target lesion Sum LD', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '243'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '450'}, {'value': '71', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '450'}]}]}], 'paramType': 'MEDIAN', 'description': 'Site, location \\& longest diameter (LD) for each of up to 10 measurable Target Lesions (TL) measured. At baseline the sum of the LD for all TL is reported as baseline sum LD. At follow-up visits the sum of the LD for all TL is reported as follow-up LD.', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Vital Signs: Pulse rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '100'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '120'}, {'value': '71.5', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Beats per minutes', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Totals are patients with available data'}, {'title': 'Vital Signs: Systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000', 'lowerLimit': '97', 'upperLimit': '192'}, {'value': '136', 'groupId': 'BG001', 'lowerLimit': '113', 'upperLimit': '175'}, {'value': '137', 'groupId': 'BG002', 'lowerLimit': '97', 'upperLimit': '192'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Totals are patients with available data'}, {'title': 'Diastolic BP', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '115'}, {'value': '82', 'groupId': 'BG001', 'lowerLimit': '68', 'upperLimit': '95'}, {'value': '83.5', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '115'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Totals are patients with available data'}, {'title': 'Biochemistry: Bilirubin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '21'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '18'}, {'value': '9', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Numbers analysed are available data'}, {'title': 'Biochemistry: Creatine clearance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '233'}, {'value': '94', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '194'}, {'value': '98', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '233'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ml/min', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Numbers analysed are available data'}, {'title': 'Haematology: Haemoglobin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '16'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '17'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Numbers analysed are those with available data'}], 'populationDescription': 'All randomised patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-29', 'size': 1109987, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-18T03:22', 'hasProtocol': True}, {'date': '2013-02-28', 'size': 594720, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-25T08:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-14', 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression Free Survival: Sensitivity Analysis 1', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Same as for primary analysis. This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST v1.1 criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.'}, {'measure': 'Progression Free Survival- Per Protocol Analysis', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Same as for primary analysis. This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST v1.1. criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.'}], 'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST (v1.1) criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival Rate at 6 Months', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'PFS at 6 months is defined as the percentage progression free survival at 6 months from the PFS Kaplan Meier graph. This would allow all patients randomised to be included. progression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria.'}, {'measure': 'Overall Survival', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'This is defined as the time from randomisation to death (event) or time from randomisation to date last known alive (censored time).'}, {'measure': 'Objective Response Rate', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'Objective response rate calculated as number of patients with Complete Response (CR) or Partial response (PR) over all patients randomised. The numerator of the objective response rate is the number of patients achieving a CR or PR. The denominator is all patients randomised. RECIST(v1.1) criteria was used for assessment.'}, {'measure': 'Overall Survival Results - Post Final Analysis', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.', 'description': 'OS analysis was carried out at the final analysis time point on data taken on 01Oct2012. Another data extraction was taken on 05Mar2013 in order to carry out posthoc analyses, OS was analysed again on this data.\n\nOS is time from randomisation to death (event) or time from randomisation to date last known alive (censored time).'}, {'measure': 'Vital Signs - Temperature', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - temperature.'}, {'measure': 'Vital Signs - Pulse Rate', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - pulse rate.'}, {'measure': 'Vital Signs - Systolic Blood Pressure', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - systolic blood pressure.'}, {'measure': 'Vital Signs - Diastolic Blood Pressure', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Vital signs - diastolic blood pressure.'}, {'measure': 'Weight', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Weight.'}, {'measure': 'Haematology - Haemoglobin', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Haematology - haemoglobin.'}, {'measure': 'Haematology - White Cell Count', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are median values across all time-points for all patients in that arm.', 'description': 'Haematology - white cell count.'}, {'measure': 'Haematology - Neutrophils', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Haematology - neutrophils.'}, {'measure': 'Haematology - Platelets', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Haematology - platelets.'}, {'measure': 'Biochemistry - Phosphate', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - phosphate.'}, {'measure': 'Biochemistry - Calcium', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - calcium.'}, {'measure': 'Biochemistry - Sodium', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - sodium.'}, {'measure': 'Biochemistry - Potassium', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - potassium.'}, {'measure': 'Biochemistry - Urea', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - urea.'}, {'measure': 'Biochemistry - Bilirubin', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - bilirubin.'}, {'measure': 'Biochemistry - Alkaline Phosphatase', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - alkaline phosphatase.'}, {'measure': 'Biochemistry - ALT', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - ALT.'}, {'measure': 'Biochemistry - AST', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - AST.'}, {'measure': 'Biochemistry - Albumin', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - albumin.'}, {'measure': 'Biochemistry - GGT', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - GGT.'}, {'measure': 'Biochemistry - Total Protein', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - total protein.'}, {'measure': 'Biochemistry - LDH', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - LDH.'}, {'measure': 'Biochemistry - Creatinine', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.', 'description': 'Biochemistry - creatinine.'}, {'measure': 'Physical Assessment - General Appearance', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical assessment - general appearance.'}, {'measure': 'Physical Exam - Skin', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - skin.'}, {'measure': 'Physical Exam - Head and Neck', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - head and neck.'}, {'measure': 'Physical Exam - Chest', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - chest.'}, {'measure': 'Physical Exam - Cardiovascular', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - cardiovascular.'}, {'measure': 'Physical Exam - Abdomen', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - abdomen.'}, {'measure': 'Physical Exam - Lymph Nodes', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - lymph nodes.'}, {'measure': 'Physical Exam - Extremities', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - extremities.'}, {'measure': 'Physical Exam - Musculoskeletal', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - musculoskeletal.'}, {'measure': 'Physical Exam - Neurological', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - neurological.'}, {'measure': 'Physical Exam - Other', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Physical exam - other.'}, {'measure': 'ECG - Pre-dose', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'ECG - pre-dose.'}, {'measure': 'ECG - Post-dose', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'ECG - post-dose.'}, {'measure': 'Urinalysis', 'timeFrame': 'From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.', 'description': 'Urinalysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind placebo controlled phase 2 trial. Patient will be randomly assigned 1:1 between 2 treatment arms. They will receive either docetaxel 75mg/m2 IV and placebo given bd, or AZD6244 75mg bd daily with docetaxel 75mg/m2 IV. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244/placebo may be continued beyond this, until disease progression. The objective is to assess whether the combination of AZD6244 with docetaxel is worthy of evaluation in a definitive randomised study, with the null hypothesis being that the combination has activity similar to that of docetaxel alone in this population. After consent has been obtained mutational analysis of tumour BRAF will be performed on archival tumour tissue, where this information is not already known, to assess eligibility for the study. If there is no archival tissue a fresh biopsy will be requested from the patient. A blood sample will also be taken for future genetic analysis. Once taking part in the trial patients will need to attend their oncology unit regularly for monitoring and the delivery of treatment. Patients will undergo complete physical examination at screening, on C1D1, C1D8, C1D15, C2D1, C2D8 and day 1 of every subsequent cycle. Blood for haematology, biochemistry and clotting will be taken at each of these visits. A 12 lead ECG will be performed at screening . Disease assessment will be by CT scanning using modified RECIST criteria after 9 and 18 weeks, then every 3 months until disease progression.', 'detailedDescription': 'No further information in addition to what has been provided in the brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>/= 16 years\n* Able to provide evidence from an accredited laboratory of wt BRAF status for their melanoma, or ascertainment of wt BRAF status from a sample of melanoma provided for mutational analysis in Oxford.\n* Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma\n* At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by modified RECIST criteria\n* ECOG performance score of 0 or 1.\n* Life expectancy of at least 12 weeks.\n* The patient is willing to give consent to the main study and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations.\n* Haematological and biochemical indices within the ranges shown below. Lab Test Value required Haemoglobin (Hb) \\>10g/dL White Blood Count (WBC) \\> 3x109/L Platelet count \\> 100,000/μL Absolute Neutrophil count \\> 1.5x109/L; Serum bilirubin ≤ 1.2 x ULN AST (SGOT) or ALT ≤ 2.5 x ULN LDH ≤ 2 x ULN Creatinine clearance (Cockcroft-Gault) \\>50 ml/min\n\nExclusion Criteria:\n\n* Any anti-cancer therapy (including radiotherapy and participation in other clinical trials) within 28 days prior to Day 1.\n* Prior DNA damaging agents or cytotoxic chemotherapy for metastatic melanoma.\n* Any unresolved toxicity from prior anti-cancer therapy that is greater than CTCAE grade 2.\n* Pregnancy or breastfeeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post-menopausal status (defined as absence of menstruation for \\> 12 months, bilateral oophrectomy or hysterectomy).\n* Grade ≥2 peripheral neuropathy at study entry.\n* Patients of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (both male and female patients)\n* Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80\n* Ocular or mucosal malignant melanoma\n* Another active malignancy within the past five years.\n* Evidence of brain metastases, unless surgically resected/stereotactic radiosurgery treated brain metastasis with no evidence of relapse on cerebral MRI, or treated brain metastasis and stable off treatment, including steroids, for 3 months.\n* Clinically significant and uncontrolled major medical condition(s): such as active infection, bleeding diathesis.\n* Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.\n* Cardiac conditions, including uncontrolled hypertension (BP\\>160/100 despite treatment), heart failure NYHA class 2 or above, prior or current cardiomyopathy, myocardial infarction within 6 months or angina requiring nitrate therapy more than once a week.\n* Previous treatment with EGFR, ras, raf or MEK inhibitors.\n* Inability to swallow capsules, refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.\n* Taking medication that significantly induces or inhibits CYP3A4.'}, 'identificationModule': {'nctId': 'NCT01256359', 'acronym': 'DOC-MEK', 'briefTitle': 'Docetaxel With or Without AZD6244 in Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Double Blind Randomised Phase 2 Trial of Docetaxel With or Without AZD6244 in wt BRAF Advanced Melanoma', 'orgStudyIdInfo': {'id': 'OCTO_015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxel and AZD6244', 'description': 'Docetaxel with AZD6244', 'interventionNames': ['Drug: Docetaxel and AZD6244']}, {'type': 'EXPERIMENTAL', 'label': 'Docetaxel and Placebo', 'description': 'Docetaxel without AZD6244', 'interventionNames': ['Drug: Docetaxel and placebo']}], 'interventions': [{'name': 'Docetaxel and AZD6244', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.', 'armGroupLabels': ['Docetaxel and AZD6244']}, {'name': 'Docetaxel and placebo', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.', 'armGroupLabels': ['Docetaxel and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LJ', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Mark R Middleton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}