Viewing Study NCT00423332

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Ignite Creation Date: 2025-12-24 @ 9:36 PM
Ignite Modification Date: 2025-12-30 @ 9:27 PM
Study NCT ID: NCT00423332
Status: COMPLETED
Last Update Posted: 2017-02-02
First Post: 2007-01-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500926', 'term': 'cediranib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cediranib DB', 'description': 'Double Blind part', 'otherNumAtRisk': 53, 'otherNumAffected': 53, 'seriousNumAtRisk': 53, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Placebo DB', 'description': 'Double Blind part', 'otherNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Cediranib OL', 'description': 'Open Label part', 'otherNumAtRisk': 58, 'otherNumAffected': 57, 'seriousNumAtRisk': 58, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Splinter Haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Feeling Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Appetite Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flank Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Joint Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Groin Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, 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'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Reversible Posterior Leukoencephalopathy Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Bartholin's Cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dermatitis Bullous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Tumour Size at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo/Day'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.47', 'spread': '17.093', 'groupId': 'OG000'}, {'value': '19.65', 'spread': '22.902', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\\*100', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data'}, {'type': 'SECONDARY', 'title': 'Best Percentage Change From Baseline in Tumour Size During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo/Day'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.90', 'spread': '23.153', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '26.783', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment period up to Week 12 visit date for last patient in (LPI)', 'description': 'Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo/Day'}], 'classes': [{'categories': [{'measurements': [{'value': '18.595', 'groupId': 'OG000', 'lowerLimit': '12.517', 'upperLimit': '18.595'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment period up to 2nd data cut-off of 8th March 2009', 'description': 'Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)).\n\n13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo/Day'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21.6'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment period up to 2nd data cut-off of 8th March 2009.', 'description': 'Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib.'}, {'type': 'SECONDARY', 'title': 'Objective Tumour Response at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo/Day'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.', 'description': 'Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Objective Tumour Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo/Day'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 and every 8 weeks thereafter or until progression.', 'description': 'Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a 'best response' summary."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day: 53 patients randomised'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo / Day: 18 patients randomised'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised', 'groupId': 'FG000', 'numSubjects': '53'}, {'comment': 'Number randomised', 'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Continuing After Unblinding', 'achievements': [{'comment': 'Number starting/ continuing AZD2171 after unblinding', 'groupId': 'FG000', 'numSubjects': '44'}, {'comment': 'Number starting/ continuing AZD2171 after unblinding', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Ongoing at Data Cut Off (8th March 2009)', 'achievements': [{'comment': 'Number ongoing at data cut off (8th March 2009)', 'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'Number ongoing at data cut off (8th March 2009)', 'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number completing 12 weeks blinded randomised treatment', 'groupId': 'FG000', 'numSubjects': '44'}, {'comment': 'Number completing 12 weeks blinded randomised treatment', 'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Condition under investigation worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive at Week 6', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unblinded before 12 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Seventy-one patients were randomised to study treatment: 53 to cediranib 45 mg and 18 to placebo. Following unblinding for the primary analysis, all patients, except those who had progressed on cediranib, then had the option of receiving open-label treatment with cediranib. Randomised=ITT=Safety set: Cediranib 45mg 53, Placebo 18.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD2171 45 mg', 'description': 'AZD2171 45mg/Day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo/Day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at informed consent', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender at informed consent', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2011-04-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-08', 'studyFirstSubmitDate': '2007-01-16', 'dispFirstSubmitQcDate': '2011-04-06', 'resultsFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2007-01-16', 'dispFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-03', 'studyFirstPostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Tumour Size at 12 Weeks', 'timeFrame': 'Baseline to Week 12', 'description': 'Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\\*100'}], 'secondaryOutcomes': [{'measure': 'Best Percentage Change From Baseline in Tumour Size During the Study', 'timeFrame': 'Treatment period up to Week 12 visit date for last patient in (LPI)', 'description': 'Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions'}, {'measure': 'Duration of Response', 'timeFrame': 'Treatment period up to 2nd data cut-off of 8th March 2009', 'description': 'Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Treatment period up to 2nd data cut-off of 8th March 2009.', 'description': 'Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.'}, {'measure': 'Objective Tumour Response at 12 Weeks', 'timeFrame': 'Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.', 'description': 'Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.'}, {'measure': 'Best Objective Tumour Response', 'timeFrame': 'Baseline, Week 12 and every 8 weeks thereafter or until progression.', 'description': 'Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).'}]}, 'conditionsModule': {'keywords': ['cancer', 'tumour', 'advanced cancer', 'Metastatic renal cell carcinoma', 'kidney cancer', 'RECENTIN'], 'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '22285180', 'type': 'DERIVED', 'citation': 'Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jurgensmeier JM, Gore ME. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer. 2012 Mar;48(4):527-37. doi: 10.1016/j.ejca.2011.12.022. Epub 2012 Jan 28.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=419&filename=CSR-D8480C00030.pdf', 'label': 'CSR-D8480C00030.pdf'}]}, 'descriptionModule': {'briefSummary': 'Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmation of metastatic or recurrent renal cell carcinoma\n\nExclusion Criteria:\n\n* Certain types of previous anti-cancer therapy for Renal Cell Carcinoma\n* Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes\n* Patients with a history of poorly controlled high blood pressure'}, 'identificationModule': {'nctId': 'NCT00423332', 'briefTitle': 'Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo Following 12 Weeks of Treatment in Patients With Metastatic or Recurrent Renal Cell Carcinoma Who Have Had no Previous Anti-VEGF Therapy.', 'orgStudyIdInfo': {'id': 'D8480C00030'}, 'secondaryIdInfos': [{'id': 'EudraCT no. 2006-002455-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Cediranib placebo', 'interventionNames': ['Drug: Cediranib Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Cediranib', 'interventionNames': ['Drug: Cediranib']}], 'interventions': [{'name': 'Cediranib', 'type': 'DRUG', 'otherNames': ['AZD2171', 'RECENTIN™'], 'description': '45 mg oral tablet', 'armGroupLabels': ['2']}, {'name': 'Cediranib Placebo', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Northwood', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Jane Robertson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}