Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT01933932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C517975', 'term': 'AZD 6244'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], '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': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+44 (0)1763 263801', 'title': 'Dr Gabriella Mariani', 'organization': 'AstraZeneca Research and Development'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.', 'description': 'The total number of patients at risk are taken from the number of patients in the safety analysis set. They are patients who received at least one dose of randomised investigational product (selumetinib/placebo). (The numbers in the participant flow module are randomised patients).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.', 'otherNumAtRisk': 254, 'otherNumAffected': 235, 'seriousNumAtRisk': 254, 'seriousNumAffected': 82}, {'id': 'EG001', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle', 'otherNumAtRisk': 251, 'otherNumAffected': 244, 'seriousNumAtRisk': 251, 'seriousNumAffected': 124}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 50, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oestrogen deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chorioretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctival irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eyelid skin dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Optic nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Presbyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinal vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Internal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.9'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.4355', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis stratified by WHO performance status at randomisation.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population comprised of all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '16.8'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '20.1'}]}]}], 'analyses': [{'pValue': '0.6431', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.30', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis stratified by WHO performance status at randomisation.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI', 'description': 'Overall Survival is defined as the time from the date of randomisation until death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population comprised of all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0515', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.62', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis stratified by WHO performance status at randomisation'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - \\>=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)', 'unitOfMeasure': 'Number of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population comprised of all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '82.0', 'upperLimit': '126.0'}, {'value': '136.0', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '169.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population comprised of all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.86', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis stratified by WHO performance status at randomisation'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.', 'unitOfMeasure': 'Number of patients with improvements', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) patients who have a baseline ASBI score \\>= 10'}, {'type': 'SECONDARY', 'title': 'Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '4.6'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.3438', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis stratified by WHO performance status at randomisation.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) patients who have a baseline ASBI score \\<= 90'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'FG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '256'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'These were the number of patients who were still ongoing at data cut-off', 'groupId': 'FG000', 'numSubjects': '70'}, {'comment': 'These were the number of patients who were still ongoing at data cut-off', 'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '178'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study started with an assessment visit where a tumour KRAS mutation assessment was performed, eligibility assessments were performed and informed consent obtained. Eligible patients were randomised at the next visit. Patients then received double-blinded study treatment, were seen and assessments performed until objective disease progression.', 'preAssignmentDetails': 'Eligible patients randomised in a ratio of 1:1 to receive selumetinib (AZD6244; ARRY-142886) 75 mg bd in combination with docetaxel 75 mg/m2 or placebo in combination with docetaxel 75 mg/m2. They were stratified based on their WHO performance status and tumour histology. 510 patients enrolled and 510 randomised.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Selumetinib + Docetaxel', 'description': 'Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle'}, {'id': 'BG001', 'title': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '8.48', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '8.08', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '8.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '>=65 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': '<65 years', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnic group', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2013-08-29', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2017-08-28', 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI', 'description': 'Overall Survival is defined as the time from the date of randomisation until death due to any cause.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - \\>=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)'}, {'measure': 'Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)', 'timeFrame': 'Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.'}, {'measure': 'Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)', 'timeFrame': 'Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)', 'description': 'Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; metastatic; second line treatment for Non Small Cell Lung Cancer; KRAS mutation'], 'conditions': ['Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV']}, 'referencesModule': {'references': [{'pmid': '28492898', 'type': 'DERIVED', 'citation': 'Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.'}, {'pmid': '26837474', 'type': 'DERIVED', 'citation': 'Janne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1830&filename=D1532C00079_SELECT1redacted_study_protocol_approved.pdf', 'label': 'CSP\\_redacted'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel', 'detailedDescription': 'A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed, written and dated informed consent prior to any study specific procedures\n* Male or female, aged 18 years or older\n* Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)\n* KRAS mutation positive tumour sample as determined by the designated testing laboratory\n* Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy\n\nExclusion Criteria:\n\n* Mixed small cell and non-small cell lung cancer histology.\n* Received \\>1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.\n* Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment\n* Other concomitant anti-cancer therapy agents excepts steroids\n* Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).\n* Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment'}, 'identificationModule': {'nctId': 'NCT01933932', 'acronym': 'SELECT-1', 'briefTitle': 'Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)', 'orgStudyIdInfo': {'id': 'D1532C00079'}, 'secondaryIdInfos': [{'id': '2013-001676-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selumetinib + Docetaxel', 'description': 'Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle', 'interventionNames': ['Drug: Selumetinib', 'Drug: Docetaxel', 'Drug: Pegylated G-CSF']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + Docetaxel', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.', 'interventionNames': ['Drug: Docetaxel', 'Drug: Placebo', 'Drug: Pegylated G-CSF']}], 'interventions': [{'name': 'Selumetinib', 'type': 'DRUG', 'otherNames': ['AZD6244; ARRY-142886'], 'description': 'Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.', 'armGroupLabels': ['Selumetinib + Docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.', 'armGroupLabels': ['Placebo + Docetaxel', 'Selumetinib + Docetaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.', 'armGroupLabels': ['Placebo + Docetaxel']}, {'name': 'Pegylated G-CSF', 'type': 'DRUG', 'otherNames': ['Pegfilgrastim 6 mg'], 'description': 'All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.', 'armGroupLabels': ['Placebo + Docetaxel', 'Selumetinib + Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 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