Viewing Study NCT01101451

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Ignite Creation Date: 2025-12-24 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
Study NCT ID: NCT01101451
Status: COMPLETED
Last Update Posted: 2025-05-23
First Post: 2010-04-09
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
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': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'huangh@nrgoncology.org', 'phone': '7168452318', 'title': 'Helen Huang on behalf of Wei Deng Ph.D.', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During treatment period and up to 21 days after stopping the study treatment. The median treatment duration was 39 days.', 'description': 'All randomized participants who received any assigned protocol therapy were monitored/assessed for serious adverse events and other adverse events. Randomized eligible participants were monitored/assessed for All-Cause Mortality.\n\nThe All-Cause Mortality that occurred from randomization until 54 RFS events have occurred with a median follow-up 76.5 months (inter-quartile range: 50.3 to 107.7 months) estimated by reverse Kaplan-Meier method.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 158, 'otherNumAffected': 140, 'seriousNumAtRisk': 170, 'deathsNumAffected': 20, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 158, 'otherNumAffected': 158, 'seriousNumAtRisk': 161, 'deathsNumAffected': 12, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Blood And Lymphatic System Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 95}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paroxysmal Atrial Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest Pain - Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear And Labyrinth Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 19}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Endocrine Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Eye Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flashing Lights', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stomach Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lower Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 117}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fecal Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hemorrhoidal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Localized Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion Site Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu Like Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Immune System Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections And Infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vulval Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Soft Tissue Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymph Gland Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pelvic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Device 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'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cystitis Noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bladder Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Reproductive System And Breast Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal 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'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspareunia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Postnasal Drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nasal 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'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin And Subcutaneous Tissue Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Scalp Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain Of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hirsutism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erythroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Surgical And Medical Procedures - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Blood And Lymphatic System Disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colonic Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections And Infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White Blood Cell Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest Wall Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Tract Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recurrence-free Survival (RFS) Rate at 3-years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'OG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '90'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '93'}]}]}], 'analyses': [{'pValue': '0.0927', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6976', 'ciLowerLimit': '0.408', 'ciUpperLimit': '1.192', 'pValueComment': 'the pre\\_specified nominal significance level was 0.0451 (one sided).', 'estimateComment': 'The RFS hazard ratio estimate is for reporting group 2 vs reporting group 1.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years from randomization', 'description': 'Estimate for probability of RFS at 3 years using Kaplan-Meier method, where RFS is defined as time from protocol registration (and randomization) to the date of first documented recurrence, death, or the date of last contact, whichever occurs first. Patients without recurrence or death were censored at the date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Rate at 3-years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'OG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '94'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.586', 'ciLowerLimit': '0.286', 'ciUpperLimit': '1.199', 'estimateComment': 'The OS hazard ratio estimate is for reporting group 2 vs reporting group 1.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years from randomization', 'description': 'Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'OG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Other blood/lymphatics', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell decreased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Other investigations', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'General and administration site', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Infections/infestations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism/nutrition', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal/connective tissue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous system', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Renal/urinary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Reproductive/breast', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin/subcutaneous', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During treatment period and up to 21 days after stopping the study treatment. The median treatment duration was 39 days.', 'description': 'Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received any assigned protocol therapy'}, {'type': 'SECONDARY', 'title': 'Patient Risk-benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'OG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}], 'timeFrame': 'up to 11 years', 'description': 'The reporting group (2) did not demonstrate improved RFS compared to the reporting group (1) at the pre-specified significance level. Per the protocol, patient risk-benefit will be assessed only for a positive study.\n\nThis is not assessed due to non-positive study per the protocol.', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, patient risk-benefit will be assessed only for a positive study. Based on the results information at the specified significance level, patient risk-benefit was not assessed as pre-specified'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured With the FACT-Cx TOI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'OG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '83.5', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': '3 weeks', 'categories': [{'measurements': [{'value': '79.0', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': '7 weeks', 'categories': [{'measurements': [{'value': '80.1', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '71.8', 'spread': '17.1', 'groupId': 'OG001'}]}]}, {'title': '36 weeks', 'categories': [{'measurements': [{'value': '88.8', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1. Pre-treatment (baseline), 2. 3 weeks following the first day of treatment, 3. 7 weeks following the first day of treatment, 4. 36 weeks following the first day of treatment.', 'description': 'The patient-reported QOL is assessed with the Trial Outcome Index of the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx TOI). The FACT-Cx TOI is ranged 0-116 and a larger FACT-Cx TOI score suggests a favorable QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who completed baseline and at lease one follow-up QOL assessments.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Compliance', 'timeFrame': 'Up to 11 years', 'description': 'Assessed by the number of cycles and amount of chemoradiotherapy administered, treatment span, incidence and duration of treatment delays, reason for delays, and reason why off study therapy.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Site(s) of Recurrence', 'timeFrame': 'Up to 11 years', 'description': 'The site(s) of first disease recurrence will be classified as: pelvic-only, extra-pelvic-only or pelvic-and-extra-pelvic and tabulated by treatment group. The test of the hypothesis that the probability of local failure is independent of randomized treatment will be assessed with exact logistic regression adjusted know prognostic factors.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Local Control', 'timeFrame': 'Up to 11 years', 'description': 'Assessed with Exact Logistic Regression adjusted known prognostic factors.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'FG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Eligible and never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Ineligible and treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Ineligible and never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'GOG-0263 opened to accrual on April 12, 2010, and closed to accrual on April 11, 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Radiation)', 'description': 'Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.'}, {'id': 'BG001', 'title': 'Arm II (Cisplatin + Radiation)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '>= 80 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-14', 'size': 1266949, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-23T13:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2010-04-09', 'resultsFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2010-04-09', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-15', 'studyFirstPostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Compliance', 'timeFrame': 'Up to 11 years', 'description': 'Assessed by the number of cycles and amount of chemoradiotherapy administered, treatment span, incidence and duration of treatment delays, reason for delays, and reason why off study therapy.'}, {'measure': 'Site(s) of Recurrence', 'timeFrame': 'Up to 11 years', 'description': 'The site(s) of first disease recurrence will be classified as: pelvic-only, extra-pelvic-only or pelvic-and-extra-pelvic and tabulated by treatment group. The test of the hypothesis that the probability of local failure is independent of randomized treatment will be assessed with exact logistic regression adjusted know prognostic factors.'}, {'measure': 'Local Control', 'timeFrame': 'Up to 11 years', 'description': 'Assessed with Exact Logistic Regression adjusted known prognostic factors.'}], 'primaryOutcomes': [{'measure': 'Recurrence-free Survival (RFS) Rate at 3-years', 'timeFrame': '3 years from randomization', 'description': 'Estimate for probability of RFS at 3 years using Kaplan-Meier method, where RFS is defined as time from protocol registration (and randomization) to the date of first documented recurrence, death, or the date of last contact, whichever occurs first. Patients without recurrence or death were censored at the date of last contact.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) Rate at 3-years', 'timeFrame': '3 years from randomization', 'description': 'Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.'}, {'measure': 'Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period.', 'timeFrame': 'During treatment period and up to 21 days after stopping the study treatment. The median treatment duration was 39 days.', 'description': 'Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.'}, {'measure': 'Patient Risk-benefit', 'timeFrame': 'up to 11 years', 'description': 'The reporting group (2) did not demonstrate improved RFS compared to the reporting group (1) at the pre-specified significance level. Per the protocol, patient risk-benefit will be assessed only for a positive study.\n\nThis is not assessed due to non-positive study per the protocol.'}, {'measure': 'Quality of Life (QOL) as Measured With the FACT-Cx TOI', 'timeFrame': '1. Pre-treatment (baseline), 2. 3 weeks following the first day of treatment, 3. 7 weeks following the first day of treatment, 4. 36 weeks following the first day of treatment.', 'description': 'The patient-reported QOL is assessed with the Trial Outcome Index of the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx TOI). The FACT-Cx TOI is ranged 0-116 and a larger FACT-Cx TOI score suggests a favorable QoL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervical Adenocarcinoma', 'Cervical Adenosquamous Carcinoma', 'Cervical Squamous Cell Carcinoma, Not Otherwise Specified', 'Stage I Cervical Cancer AJCC v6 and v7', 'Stage IA Cervical Cancer AJCC v6 and v7', 'Stage IB Cervical Cancer AJCC v6 and v7', 'Stage IIA Cervical Cancer AJCC v7']}, 'referencesModule': {'references': [{'pmid': '31912685', 'type': 'DERIVED', 'citation': 'Kim H, Park W, Kim YS, Kim YJ. Chemoradiotherapy is not superior to radiotherapy alone after radical surgery for cervical cancer patients with intermediate-risk factor. J Gynecol Oncol. 2020 May;31(3):e35. doi: 10.3802/jgo.2020.31.e35. Epub 2019 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.\n\nII. To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE).\n\nIII. To provide assessment of patient risk version (vs) benefit (positive study only).\n\nQUALITY OF LIFE OBJECTIVE:\n\nI. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events).\n\nTRANSLATIONAL RESEARCH OBJECTIVES:\n\nI. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone.\n\nII. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.\n\nARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy\n* Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):\n\n * Positive capillary-lymphovascular space involvement and one of the following:\n\n * Deep third penetration\n * Middle third penetration, clinical tumor \\>= 2 cm\n * Superficial third penetration, clinical tumor \\>= 5 cm\n * Negative capillary-lymphatic space involvement\n\n * Middle or deep third penetration, clinical tumor \\>= 4 cm\n* Absolute neutrophil count (ANC) \\>= 1,500/mcl\n* Platelets \\>= 100,000/mcl\n* Creatinine =\\< upper limit of normal (ULN) or calculated creatinine clearance \\>= 60 mL/min\n* Bilirubin =\\< 1.5 x normal\n* Alkaline phosphate =\\< 3 x normal\n* Serum glutamic oxaloacetic transaminase (SGOT) =\\< 3 x normal\n* Gynecologic Oncology Group (GOG) performance status 0, 1, 2\n* Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery\n* Patients who have met the pre-entry requirements\n* Patients must have signed an approved informed consent and authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins\n* Patients with septicemia or severe infection\n* Patients with intestinal obstruction or gastrointestinal bleeding\n* Patients with postoperative fistula\n* Patients with cervix cancer who have received any previous radiation or chemotherapy\n* Patients whose circumstances do not permit completion of the study or the required follow-up\n* Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)\n* Patients with GOG performance status of 3 or 4\n* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy'}, 'identificationModule': {'nctId': 'NCT01101451', 'briefTitle': 'Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)', 'orgStudyIdInfo': {'id': 'GOG-0263'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02037', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'GOG-0263', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0263', 'type': 'OTHER', 'domain': 'CTEP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (EBRT, IMRT)', 'description': 'Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.', 'interventionNames': ['Radiation: External Beam Radiation Therapy', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (cisplatin, EBRT, IMRT)', 'description': 'Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cisplatin', 'Radiation: External Beam Radiation Therapy', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone''s Chloride", "Peyrone''s Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (cisplatin, EBRT, IMRT)']}, {'name': 'External Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam Radiation', 'External Beam Radiotherapy', 'External Beam RT', 'external radiation', 'External Radiation Therapy', 'external-beam radiation', 'Radiation, External Beam'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Arm I (EBRT, IMRT)', 'Arm II (cisplatin, EBRT, IMRT)']}, {'name': 'Intensity-Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy', 'Radiation, Intensity-Modulated Radiotherapy'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Arm I (EBRT, IMRT)', 'Arm II (cisplatin, EBRT, IMRT)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (EBRT, IMRT)', 'Arm II (cisplatin, EBRT, IMRT)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (EBRT, IMRT)', 'Arm II (cisplatin, EBRT, IMRT)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (EBRT, IMRT)', 'Arm II (cisplatin, EBRT, IMRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Anchorage Associates in Radiation Medicine', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99504', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Anchorage Radiation Therapy Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Breast Care and Surgery LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Regional Hospital', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Women's Cancer Care", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Anchorage Oncology Centre', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Katmai Oncology Group', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99701', 'city': 'Fairbanks', 'state': 'Alaska', 'country': 'United States', 'facility': 'Fairbanks Memorial Hospital', 'geoPoint': {'lat': 64.83778, 'lon': -147.71639}}, {'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Cancer Center at Saint Joseph's", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Saint Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Mercy Hospital Fort Smith', 'geoPoint': 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{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center/Disney Family Cancer Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Medical Center', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '95682', 'city': 'Cameron Park', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Cameron Park', 'geoPoint': {'lat': 38.66879, 'lon': -120.98716}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy San Juan Medical Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Eden Hospital Medical Center', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Medical Center-Concord Campus', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Davis Hospital', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95758', 'city': 'Elk Grove', 'state': 'California', 'country': 'United States', 'facility': 'Mercy Cancer Center - Elk Grove', 'geoPoint': {'lat': 38.4088, 'lon': -121.37162}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County-USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Camino Division', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Gynecologic Oncology', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94945', 'city': 'Novato', 'state': 'California', 'country': 'United 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Cancer Centers Radiation Oncology Services-Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Roseville Medical Center', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy Cancer Center - Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Medical Center Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center-Pacific Campus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93401', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Central Coast Health Center-San Luis Obispo', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '95065', 'city': 'Santa Cruz', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Santa Cruz', 'geoPoint': {'lat': 36.97412, 'lon': -122.0308}}, {'zip': '93444', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Mission Hope Medical Oncology - Santa Maria', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Pacific Medical Foundation', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Sunnyvale', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View-University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '95687', 'city': 'Vacaville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Vacaville', 'geoPoint': {'lat': 38.35658, 'lon': -121.98774}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Solano Medical Center/Cancer Center', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Medical Center-Walnut Creek', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '95695', 'city': 'Woodland', 'state': 'California', 'country': 'United States', 'facility': 'Woodland Memorial Hospital', 'geoPoint': {'lat': 38.67852, 'lon': -121.7733}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Medical Center of Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Foothills Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose-Saint Francis Healthcare', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Penrose', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Presbyterian - Saint Lukes Medical Center - Health One', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Midtown', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'SCL Health Saint Joseph Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Rose', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81301', 'city': 'Durango', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '81301', 'city': 'Durango', 'state': 'Colorado', 'country': 'United States', 'facility': 'Southwest Oncology PC', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mountain Blue Cancer Care Center - Swedish', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mountain Blue Cancer Care Center', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "Saint Mary's Hospital and Regional Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '80631', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Colorado Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Greenwood Village', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Lakewood', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Saint Anthony Hospital', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Littleton', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '80122', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Littleton Adventist Hospital', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Sky Ridge', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United 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