Viewing Study NCT00410761

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Ignite Creation Date: 2025-12-24 @ 12:04 PM
Ignite Modification Date: 2026-02-22 @ 7:23 PM
Study NCT ID: NCT00410761
Status: COMPLETED
Last Update Posted: 2025-09-24
First Post: 2006-12-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Bulgaria', 'China', 'Serbia and Montenegro', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'C536911', 'term': 'Familial medullary thyroid carcinoma'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C452423', 'term': 'vandetanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', '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': {'timeFrame': 'Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.', 'description': 'The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized Treatment Period: Vandetanib 300 mg', 'description': "Participants received vandetanib 300 mg orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period.", 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 226, 'seriousNumAtRisk': 231, 'deathsNumAffected': 66, 'seriousNumAffected': 92}, {'id': 'EG001', 'title': 'Randomized Treatment Period: Placebo', 'description': "Participants received placebo matched to vandetanib orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period.", 'otherNumAtRisk': 99, 'deathsNumAtRisk': 100, 'otherNumAffected': 87, 'seriousNumAtRisk': 99, 'deathsNumAffected': 10, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg', 'description': 'Participants who received vandetanib 300 mg during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to continue to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 32, 'seriousNumAtRisk': 109, 'deathsNumAffected': 52, 'seriousNumAffected': 53}, {'id': 'EG003', 'title': 'Open-Label Treatment Period: Placebo/Vandetanib 300 mg', 'description': 'Participants who received placebo matched to vandetanib during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 70, 'seriousNumAtRisk': 79, 'deathsNumAffected': 41, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Corneal Opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 50, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 180, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 36, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 39, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 33, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 97, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 17, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 45, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 64, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 43, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Electrocardiogram Qt Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 46, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 37, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 41, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 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25.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Photosensitivity Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 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25.1'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Accelerated Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Jugular Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Pelvic Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}, {'term': 'Vena Cava Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13 - 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival(PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'comment': 'PFS is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '19.2', 'comment': 'PFS is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.', 'description': 'Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.', '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 defined by RECIST criteria.\n\nThe categories for best objective response are CR, PR, stable disease (SD)\\>= 12 weeks, progressive disease (PD) or NE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent', 'description': 'Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \\>= 12 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'comment': 'DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.3', 'comment': 'DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent', 'description': "Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '98.5'}, {'value': '80.4', 'comment': 'NA indicates that the upper limit of confidence interval was not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until death, up to approximately 105 months', 'description': 'OS is defined as the time from the date of randomization until death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemical Response Calcitonin (CTN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up', 'description': 'Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemical Response Carcinoembryonic Antigen (CEA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up', 'description': 'Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Worsening of Pain (TWP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '7.85', 'groupId': 'OG000', 'lowerLimit': '5.39', 'upperLimit': '12.16'}, {'value': '3.25', 'groupId': 'OG001', 'lowerLimit': '1.87', 'upperLimit': '5.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.', 'description': 'TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain. TWP results are presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vandetanib 300 mg/Vandetanib 300 mg', 'description': "Participants received vandetanib 300 mg orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period. Upon disease progression or implementation of protocol amendment 6, participants who were unblinded were given the option to enter the open-label treatment period and continue to receive vandetanib 300 mg orally once daily for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy."}, {'id': 'FG001', 'title': 'Placebo/Vandetanib 300 mg', 'description': "Participants received placebo matched to vandetanib orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period. Upon disease progression or implementation of protocol amendment 6, participants who were unblinded were given the option to enter the open-label treatment period and receive vandetanib 300 mg orally once daily for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy."}], 'periods': [{'title': 'Randomized Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'Received Randomized Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'comment': 'Participants who ended randomized treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Objective Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Randomized but did not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who discontinued randomized treatment and received open-label treatment (vandetanib 300 mg).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'comment': 'Participants who ended open-label treatment (vandetanib 300 mg).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Objective Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'A total of 331 participants were enrolled in the study. The study was conducted at 60 study sites in 23 countries. First participant enrolled 23 November 2006, last participant enrolled 19 October 2007.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vandetanib 300 mg', 'description': 'Vandetanib (300 mg daily)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '83'}, {'value': '53.4', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '84'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set included all randomized 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': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2011-03-28', 'completionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2006-12-06', 'dispFirstSubmitQcDate': '2011-03-28', 'resultsFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2006-12-12', 'dispFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-22', 'studyFirstPostDateStruct': {'date': '2006-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival(PFS)', 'timeFrame': 'RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.', 'description': 'Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.', '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 defined by RECIST criteria.\n\nThe categories for best objective response are CR, PR, stable disease (SD)\\>= 12 weeks, progressive disease (PD) or NE.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent', 'description': 'Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \\>= 12 weeks'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent', 'description': "Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met"}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of randomization until death, up to approximately 105 months', 'description': 'OS is defined as the time from the date of randomization until death.'}, {'measure': 'Biochemical Response Calcitonin (CTN)', 'timeFrame': 'Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up', 'description': 'Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.'}, {'measure': 'Biochemical Response Carcinoembryonic Antigen (CEA)', 'timeFrame': 'Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up', 'description': 'Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.'}, {'measure': 'Time to Worsening of Pain (TWP)', 'timeFrame': 'During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.', 'description': 'TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain. TWP results are presented.'}]}, 'conditionsModule': {'keywords': ['ZD6474', 'MTC', 'Hereditary Medullary Thyroid Cancer', 'Sporadic Medullary Thyroid Cancer', 'Medullary Thyroid Cancer'], 'conditions': ['Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '22025146', 'type': 'RESULT', 'citation': 'Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=348&filename=CSR-D4200C00058.pdf', 'label': 'CSR-D4200C00058.pdf'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.\n* Presence of measurable tumor\n* Able to swallow medication\n\nExclusion Criteria:\n\n* Major surgery within 4 weeks before randomization\n* Last dose of prior chemotherapy received less than 4 weeks prior to randomization\n* Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)\n* Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days\n* Significant cardiac events\n* Previous ZD6474 treatment'}, 'identificationModule': {'nctId': 'NCT00410761', 'briefTitle': 'An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer', 'orgStudyIdInfo': {'id': 'D4200C00058'}, 'secondaryIdInfos': [{'id': 'LPS14811', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}, {'id': '2005-005077-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Placebo vandetanib'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Vandetanib', 'interventionNames': ['Drug: ZD6474 (Vandetanib)']}], 'interventions': [{'name': 'ZD6474 (Vandetanib)', 'type': 'DRUG', 'otherNames': ['ZACTIMA™', 'SAR390530'], 'description': 'once daily oral tablet', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 3', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University Arkansas Site Number : 3', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'USCF / Mt Zion Medical Center Site Number : 8', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 9', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University Of Colorado Health Sciences Center Site Number : 9', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Investigational Site Number 11', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School Medicine Site Number : 11', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 15', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic- Site Number : 15', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 18', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University Of Chicago Site Number : 18', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536-0298', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 17', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40536-0298', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The University Of Kentucky Site Number : 17', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute Site Number : 2', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 2', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 7', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University / Harper Hospital Site Number : 7', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site Number 14', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic- Site Number : 14', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 10', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School Of Med Site Number : 10', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45267-0589', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 6', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267-0589', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Of Cincinnati Site Number : 6', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number 22', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University- Site Number : 22', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 19', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina- Site Number : 19', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Anderson Cancer Center Site Number : 13', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 13', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care Site Number : 21', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Investigational Site Number 21', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '2065', 'city': 'St Leonards', 'country': 'Australia', 'facility': 'Investigational Site Number 1001', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '1901', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 1901', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1901', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number : 1901', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Anderlecht', 'country': 'Belgium', 'facility': 'Investigational Site Number : 1101', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigational Site Number 1101', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigational Site Number 1102', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigational Site Number : 1102', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital De Clinicas De Porto Alegre- Site Number : 2301', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina de Ribeirao Preto - USP- Site Number : 2302', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '90035-003', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Investigational Site Number 2301', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14048-900', 'city': 'Ribeirão Preto', 'country': 'Brazil', 'facility': 'Investigational Site Number 2302', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': 'T2E7C5', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Investigational Site Number : 1203', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'E1C6Z8', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Investigational Site Number : 1201', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational Site Number : 1202', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational Site Number : 1205', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Investigational Site Number : 1204', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'T2E7C5', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Investigational Site Number 1203', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N6A 4L6', 'city': 'London', 'country': 'Canada', 'facility': 'Investigational Site Number 1202', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'E1C6Z8', 'city': 'Moncton', 'country': 'Canada', 'facility': 'Investigational Site Number 1201', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'Investigational Site Number 1204', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'M5G2M9', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 1205', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 3601', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number : 3601', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Investigational Site Number 2701', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Investigational Site Number : 2701', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Investigational Site Number 2802', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Investigational Site Number : 2802', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Investigational Site Number 2803', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Investigational Site Number : 2803', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Investigational Site Number 2801', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Investigational Site Number : 2801', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigational Site Number 2002', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigational Site Number : 2002', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Investigational Site Number 2001', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Investigational Site Number : 2001', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Investigational Site Number 2005', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Investigational Site Number : 2005', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Investigational Site Number 1601', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Investigational Site Number : 1601', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '400012', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number 1401', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400012', 'city': 'Mumbai', 'country': 'India', 'facility': 'Investigational Site Number : 1401', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '632004', 'city': 'Vellore', 'country': 'India', 'facility': 'Investigational Site Number 1402', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'zip': '632004', 'city': 'Vellore', 'country': 'India', 'facility': 'Investigational Site Number : 1402', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Investigational Site Number 2506', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Investigational Site Number : 2506', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Investigational Site Number 2502', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Investigational Site Number : 2502', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Investigational Site Number 2503', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Investigational Site Number : 2503', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Investigational Site Number 2501', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Investigational Site Number : 2501', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number 2505', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number : 2505', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Investigational Site Number 2504', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Investigational Site Number : 2504', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Ciudad Madero', 'country': 'Mexico', 'facility': 'Investigational Site Number 2403', 'geoPoint': {'lat': 22.2475, 'lon': -97.83665}}, {'zip': '14000', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigational Site Number 2402', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '06726', 'city': 'México', 'country': 'Mexico', 'facility': 'Investigational Site Number 2404', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '06726', 'city': 'México', 'country': 'Mexico', 'facility': 'Investigational Site Number : 2404', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Investigational Site Number 2902', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Investigational Site Number : 2902', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Investigational Site Number 2901', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Investigational Site Number : 2901', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '60-355', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Investigational Site Number : 1702', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Investigational Site Number : 1703', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '44-101', 'city': 'Gliwice', 'country': 'Poland', 'facility': 'Investigational 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