Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 12:33 PM
Study NCT ID:
NCT00364351
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2006-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C452423', 'term': 'vandetanib'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Analysis Set included all randomized participant who received at least 1 dose of randomized treatment, 623 in vandetanib and 614 in erlotinib.', 'eventGroups': [{'id': 'EG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg.', 'otherNumAtRisk': 623, 'otherNumAffected': 539, 'seriousNumAtRisk': 623, 'seriousNumAffected': 197}, {'id': 'EG001', 'title': 'Erlotinib', 'description': 'Erlotinib.', 'otherNumAtRisk': 614, 'otherNumAffected': 542, 'seriousNumAtRisk': 614, 'seriousNumAffected': 155}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 87}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 300}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 232}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 131}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 91}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 109}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 123}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 40}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 92}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 70}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 50}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 103}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 84}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 67}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 232}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Thrombotic Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Postinfarction Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Right Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Torsade De Pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Ventricular Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Ulcerative Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Abdominal Wall Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Gastrointestinal Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Inguinal Hernia Strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Oesophageal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pulmonary Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dermatitis Exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Eczema Asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Palmar-Plantar Erythrodysaesthesia Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Photosensitivity Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rash Erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rash Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Thoracotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hypovolaemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Jugular Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Subclavian Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 623, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 614, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '75.43'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '80.43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.', 'description': 'Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.\n\nProgression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '18.46'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '20.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time to death in months', 'description': 'Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months', 'description': 'The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression', 'description': 'Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \\>= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD \\>= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '26'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '24.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit', 'description': 'Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30.\n\nTime to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of \'worsened\' with no visit assessment of \'improved\' within the next 28 days.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '29.7'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '34.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit', 'description': 'Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).\n\nTime to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of \'worsened\' with no visit assessment of \'improved\' within the next 28 days.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '36.1'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '37.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit', 'description': 'Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).\n\nTime to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of \'worsened\' with no visit assessment of \'improved\' within the next 28 days.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib'}, {'id': 'FG001', 'title': 'Erlotinib', 'description': 'Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'randomised patients', 'groupId': 'FG000', 'numSubjects': '623'}, {'comment': 'randomised patients', 'groupId': 'FG001', 'numSubjects': '617'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Ongoing study treatment at data cut-off date 26 Sep 2008.', 'groupId': 'FG000', 'numSubjects': '31'}, {'comment': 'Ongoing study treatment at data cut-off date 26 Sep 2008.', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '592'}, {'groupId': 'FG001', 'numSubjects': '583'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Condition under investigation worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '469'}, {'groupId': 'FG001', 'numSubjects': '497'}]}, {'type': 'Prohibited concomitant medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Incorrect enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Poor treatment compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Investigator error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient could not travel to site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomised treatment not started', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'First patient enrolled 24 August 2006, last patient enrolled 31 October 2007, cut off date 26 September 2008. 1574 patients were enrolled in the study.', 'preAssignmentDetails': '1574 patients were enrolled/screened to the study but only 1240 patients were entered treatment/randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '1240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vandetanib', 'description': 'Vandetanib 300 mg'}, {'id': 'BG001', 'title': 'Erlotinib', 'description': 'Erlotinib'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '92'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '85'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '381', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '774', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 1574}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2006-08-14', 'resultsFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2006-08-14', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-27', 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.', 'description': 'Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.\n\nProgression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Time to death in months', 'description': 'Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months', 'description': 'The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression', 'description': 'Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \\>= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD \\>= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.'}, {'measure': 'Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain', 'timeFrame': 'Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit', 'description': 'Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30.\n\nTime to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of \'worsened\' with no visit assessment of \'improved\' within the next 28 days.'}, {'measure': 'Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea', 'timeFrame': 'Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit', 'description': 'Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).\n\nTime to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of \'worsened\' with no visit assessment of \'improved\' within the next 28 days.'}, {'measure': 'Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough', 'timeFrame': 'Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit', 'description': 'Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).\n\nTime to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of \'worsened\' with no visit assessment of \'improved\' within the next 28 days.'}]}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer', 'NSCLC'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '21282542', 'type': 'RESULT', 'citation': 'Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.'}, {'pmid': '40785488', 'type': 'DERIVED', 'citation': 'Mishina A, Zhudenkov K, Helmlinger G, Peskov K. A Systematic Comparative Analysis of Tumor Size Models Based on Erlotinib Clinical Data in Advanced NSCLC. CPT Pharmacometrics Syst Pharmacol. 2025 Aug 11. doi: 10.1002/psp4.70095. Online ahead of print.'}, {'pmid': '25881079', 'type': 'DERIVED', 'citation': 'Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=347&filename=Vandetanib_study_57_ZEST_CSP_redacted_SECURE.pdf', 'label': 'Vandetanib\\_study\\_57\\_ZEST\\_CSP\\_redacted\\_SECURE'}]}, 'descriptionModule': {'briefSummary': 'To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed locally advanced or metastatic NSCLC\n* Failure of at least one but not more than two prior chemotherapy regimens\n\nExclusion Criteria:\n\n* Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar)\n* Chemotherapy or other type of anti cancer therapy within 4 weeks of study start'}, 'identificationModule': {'nctId': 'NCT00364351', 'briefTitle': 'Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy', 'orgStudyIdInfo': {'id': 'D4200C00057'}, 'secondaryIdInfos': [{'id': 'EUDRACT No. 2006-000259-16'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Erlotinib', 'interventionNames': ['Drug: Erlotinib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Vandetanib', 'interventionNames': ['Drug: Vandetanib']}], 'interventions': [{'name': 'Vandetanib', 'type': 'DRUG', 'otherNames': ['ZD6474', 'ZACTIMA™'], 'description': 'once daily oral tablet', 'armGroupLabels': ['2']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva®'], 'description': 'oral dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': 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