Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 11:45 AM
Study NCT ID:
NCT01168232
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2010-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}, {'id': 'D034261', 'term': 'Epothilones'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kurasa@nrgoncology.org', 'phone': '716-845-7733', 'title': 'Angela M. Kuras, Associate Director of Data Management', 'organization': 'NRG Oncology Statistics and Data Management Center - Buffalo Office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.", 'eventGroups': [{'id': 'EG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment', 'otherNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest Pain - Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hearing Impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Localized Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nail Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Inr Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fibrinogen Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White Blood Cell Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle Weakness Lower Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized Muscle Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neoplasms Benign, Malignant And Unspecified (Incl', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral Motor Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depressed Level Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Concentration Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cognitive Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Tract Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pelvic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory, Thoracic And Mediastinal Disorders -', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nail Ridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nail Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nail Discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Death Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Soft Tissue Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neoplasms Benign, Malignant And Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Adult Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days', 'description': 'Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval'}, {'type': 'PRIMARY', 'title': 'Adverse Events (Grade 3 or Higher) During Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment'}], 'classes': [{'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other Investigations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other Blood/lymphatics', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'General disorders and administration site conditio', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskelatal and connective tissue disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neoplasms benign, malignant and unspecified', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Peripheral sensory neuropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other nervous system disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Respitory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During treatment and up to 30 days after stopping the study treatment', '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': 'Eligible and Treated Participants'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.', 'description': 'Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated Patients'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '11.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study entry to death or last contact, up to 5 years of follow-up.', 'description': 'Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated Patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Eligible and treated patients', 'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Ineligible-Second primary cancer site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ineligible- Wrong cell type', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Ineligible-Inadequate pathology', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was activated on 9/7/2010 and closed to accrual on 8/26/2013 (suspended from 3/5/2012 to 9/30/2012).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixabepilone', 'description': 'Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '80-89 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histologic Type', 'classes': [{'title': 'Carcinosarcoma-heterologus', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Carcinosarcoma-homologous', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Carcinosarcoma, MMT', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Eligible and treated patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2010-07-22', 'resultsFirstSubmitDate': '2016-09-19', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-28', 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Tumor Response', 'timeFrame': 'Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days', 'description': 'Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.'}, {'measure': 'Adverse Events (Grade 3 or Higher) During Treatment Period.', 'timeFrame': 'During treatment and up to 30 days after stopping the study treatment', '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'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.', 'description': 'Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1'}, {'measure': 'Overall Survival', 'timeFrame': 'From study entry to death or last contact, up to 5 years of follow-up.', 'description': 'Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Recurrent Uterine Corpus Sarcoma', 'Uterine Carcinosarcoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.\n\nII. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the duration of progression-free survival and overall survival.\n\nTERTIARY OBJECTIVES:\n\nI. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.\n\nII. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival.\n\nOUTLINE:\n\nPatients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days 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 and then every 6 months for 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed muellerian tumor), homologous or heterologous type\n* All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \\>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \\>= 20 mm when measured by chest x-ray; lymph nodes must be \\>= 15 mm in short axis when measured by CT or MRI\n* Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy\n* Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population\n* Patients must have a GOG Performance Status of 0, 1, or 2\n* Recovery from effects of recent surgery, radiotherapy, or chemotherapy\n\n * Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \\[UTI\\])\n * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\n * Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration\n* Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen\n* Patients who have NOT received prior therapy with a taxane (such as paclitaxel or docetaxel) MUST receive a second regimen that includes a taxane\n* Patients must have NOT received any additional cytotoxic chemotherapy except as noted above\n* Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:\n\n * Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction\n* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl\n* Platelets greater than or equal to 100,000/mcl\n* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)\n* Bilirubin less than or equal to 1.5 x ULN\n* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) less than or equal to 3 x ULN\n* Alkaline phosphatase less than or equal to 2.5 x ULN\n* Patients must have signed an approved informed consent and authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Neuropathy (sensory and motor) less than or equal to grade 1\n* Patients who have met the pre-entry requirements\n* Patients of childbearing potential must have a negative serum pregnancy test 72 hours prior to the study entry and be practicing an effective form of contraception\n* Patients who have received prior therapy with Ixabepilone\n* Patients with a known history of severe (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]4.0) grade 3 or 4 hypersensitivity reaction to agents containing Cremophor? EL or its derivatives (eg, polyoxyethylated castor oil)\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy\n* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease\n* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease\n* Patients who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01168232', 'briefTitle': 'Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus', 'orgStudyIdInfo': {'id': 'NCI-2011-02056'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02056', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'GOG-0130F'}, {'id': 'CDR0000681684'}, {'id': 'GOG-0130F', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0130F', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (ixabepilone)', 'description': 'Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Ixabepilone', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Ixabepilone', 'type': 'DRUG', 'otherNames': ['(1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione', 'Azaepothilone B', 'BMS 247550', 'BMS-247550', 'BMS247550', 'Epothilone', 'Epothilone-B BMS 247550', 'Ixempra'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (ixabepilone)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (ixabepilone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, 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