Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 10:45 PM
Study NCT ID:
NCT00730158
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2008-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chue2@upmc.edu', 'phone': '(412) 648-6589', 'title': 'Edward Chu, MD', 'organization': 'UPMC Hillman Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.', 'otherNumAtRisk': 15, 'otherNumAffected': 10, 'seriousNumAtRisk': 15, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 48, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 70, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 77, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 36, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 23, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 26, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 28, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 14, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 26, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 16, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 62, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 42, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 39, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 48, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 22, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scrotal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 27, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 72, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 26, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Grade 2-4 Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.85'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '0.68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months after start of study treatment', 'description': 'The proportion of participants with a toxicity grade greater than or equal to grade 2, per NCI CTCAE 4.0. Toxicity is defined as any adverse event (AE) at least probably related to treatment occurring with 90 days of the beginning of treatment. The worst grade of AE at least probably related to treatment was determined for each participant.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that received at least 3 months of study treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m²..\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Number of participants who experienced a best response of Partial Response (PR) or Stable Disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), PR is \\>=30% decrease in the sum of the longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameter.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants evaluable for response.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'comment': 'Statistically Not Reached.', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': 'NA'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '242'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 450 days', 'description': 'Median number of days and after the treatment participants remained alive without worsening disease.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that were evaluable for response and survival data were obtainable.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '291', 'comment': 'Statistically Not Reached', 'groupId': 'OG000', 'lowerLimit': '174', 'upperLimit': 'NA'}, {'value': '482', 'comment': 'Statistically Not Reached', 'groupId': 'OG001', 'lowerLimit': '308', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 900 days', 'description': 'Median number of days from the start of treatment that study participants remained alive.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Clinical Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Progressed Disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Number of patients that experienced Progressed Disease, Stable Disease or Partial Response per RECIST 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters, and Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that were evaluable for response.'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '40.09', 'groupId': 'OG000', 'lowerLimit': '36.02', 'upperLimit': '44.16'}, {'value': '39.77', 'groupId': 'OG001', 'lowerLimit': '36.98', 'upperLimit': '42.56'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '37.66', 'groupId': 'OG000', 'lowerLimit': '34.37', 'upperLimit': '40.95'}, {'value': '35.55', 'groupId': 'OG001', 'lowerLimit': '30.98', 'upperLimit': '40.12'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '34.78', 'groupId': 'OG000', 'lowerLimit': '28.57', 'upperLimit': '40.98'}, {'value': '37.78', 'groupId': 'OG001', 'lowerLimit': '33.09', 'upperLimit': '42.47'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '37.75', 'groupId': 'OG000', 'lowerLimit': '32.64', 'upperLimit': '42.86'}, {'value': '35.65', 'groupId': 'OG001', 'lowerLimit': '29.48', 'upperLimit': '41.82'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '35.62', 'groupId': 'OG000', 'lowerLimit': '30.10', 'upperLimit': '41.15'}, {'value': '35.71', 'groupId': 'OG001', 'lowerLimit': '29.89', 'upperLimit': '41.53'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '37.09', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': '44.24'}, {'value': '31.25', 'groupId': 'OG001', 'lowerLimit': '25.53', 'upperLimit': '36.97'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '36.54', 'groupId': 'OG000', 'lowerLimit': '29.52', 'upperLimit': '43.57'}, {'value': '30.38', 'groupId': 'OG001', 'lowerLimit': '19.30', 'upperLimit': '41.47'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '38.60', 'groupId': 'OG000', 'lowerLimit': '31.49', 'upperLimit': '45.71'}, {'value': '29.33', 'groupId': 'OG001', 'lowerLimit': '19.06', 'upperLimit': '39.61'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '38.50', 'groupId': 'OG000', 'lowerLimit': '23.10', 'upperLimit': '53.90'}, {'value': '28.20', 'groupId': 'OG001', 'lowerLimit': '18.14', 'upperLimit': '38.26'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '35.67', 'groupId': 'OG000', 'lowerLimit': '16.69', 'upperLimit': '54.64'}, {'value': '32.50', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '64.27'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '30.00', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '55.41'}, {'value': '31.50', 'groupId': 'OG001', 'lowerLimit': '-25.68', 'upperLimit': '88.68'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Functional Assessment of Chronic Illness Therapy (Diarrhea), the FACIT-D, contains 11 items which address concerns related to treatment-related diarrhea. Responses are on a Likert scale and range from 0 = "Not at all" to 4 = "Very Much". Thus, total scores can range from 0 to 44. Higher scores relate to better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '23.18', 'groupId': 'OG000', 'lowerLimit': '21.09', 'upperLimit': '25.27'}, {'value': '21.79', 'groupId': 'OG001', 'lowerLimit': '18.14', 'upperLimit': '25.43'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '21.69', 'groupId': 'OG000', 'lowerLimit': '17.70', 'upperLimit': '25.68'}, {'value': '22.00', 'groupId': 'OG001', 'lowerLimit': '18.64', 'upperLimit': '25.36'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '22.00', 'groupId': 'OG000', 'lowerLimit': '18.27', 'upperLimit': '25.73'}, {'value': '22.21', 'groupId': 'OG001', 'lowerLimit': '18.64', 'upperLimit': '25.78'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '24.26', 'groupId': 'OG000', 'lowerLimit': '22.40', 'upperLimit': '26.12'}, {'value': '21.30', 'groupId': 'OG001', 'lowerLimit': '17.18', 'upperLimit': '25.42'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '22.67', 'groupId': 'OG000', 'lowerLimit': '20.12', 'upperLimit': '25.22'}, {'value': '23.09', 'groupId': 'OG001', 'lowerLimit': '20.62', 'upperLimit': '25.56'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '23.62', 'groupId': 'OG000', 'lowerLimit': '20.95', 'upperLimit': '26.30'}, {'value': '21.88', 'groupId': 'OG001', 'lowerLimit': '17.08', 'upperLimit': '26.67'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '23.50', 'groupId': 'OG000', 'lowerLimit': '21.09', 'upperLimit': '25.91'}, {'value': '20.00', 'groupId': 'OG001', 'lowerLimit': '14.37', 'upperLimit': '25.22'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '22.14', 'groupId': 'OG000', 'lowerLimit': '19.67', 'upperLimit': '24.61'}, {'value': '20.83', 'groupId': 'OG001', 'lowerLimit': '16.31', 'upperLimit': '25.36'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '22.67', 'groupId': 'OG000', 'lowerLimit': '19.37', 'upperLimit': '25.96'}, {'value': '17.40', 'groupId': 'OG001', 'lowerLimit': '11.81', 'upperLimit': '22.99'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '22.00', 'groupId': 'OG000', 'lowerLimit': '15.64', 'upperLimit': '28.36'}, {'value': '22.50', 'groupId': 'OG001', 'lowerLimit': '-9.27', 'upperLimit': '54.27'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '23.33', 'groupId': 'OG000', 'lowerLimit': '10.83', 'upperLimit': '35.84'}, {'value': '23.50', 'groupId': 'OG001', 'lowerLimit': '17.15', 'upperLimit': '29.85'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being is a 7-item subscale score of the total FACIT-D self-assessment that measures a patient\'s physical well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better physical well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '19.85', 'groupId': 'OG000', 'lowerLimit': '17.87', 'upperLimit': '21.82'}, {'value': '16.43', 'groupId': 'OG001', 'lowerLimit': '13.48', 'upperLimit': '19.38'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '18.00', 'groupId': 'OG000', 'lowerLimit': '15.19', 'upperLimit': '20.81'}, {'value': '16.43', 'groupId': 'OG001', 'lowerLimit': '13.33', 'upperLimit': '19.53'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '19.96', 'groupId': 'OG000', 'lowerLimit': '17.36', 'upperLimit': '22.55'}, {'value': '17.30', 'groupId': 'OG001', 'lowerLimit': '14.06', 'upperLimit': '20.54'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '20.11', 'groupId': 'OG000', 'lowerLimit': '17.52', 'upperLimit': '22.70'}, {'value': '17.76', 'groupId': 'OG001', 'lowerLimit': '14.11', 'upperLimit': '21.41'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '19.33', 'groupId': 'OG000', 'lowerLimit': '16.76', 'upperLimit': '21.91'}, {'value': '19.55', 'groupId': 'OG001', 'lowerLimit': '17.39', 'upperLimit': '21.70'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '20.38', 'groupId': 'OG000', 'lowerLimit': '17.81', 'upperLimit': '22.94'}, {'value': '18.75', 'groupId': 'OG001', 'lowerLimit': '15.22', 'upperLimit': '22.28'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '19.88', 'groupId': 'OG000', 'lowerLimit': '17.53', 'upperLimit': '22.22'}, {'value': '17.20', 'groupId': 'OG001', 'lowerLimit': '11.35', 'upperLimit': '23.05'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '20.57', 'groupId': 'OG000', 'lowerLimit': '18.25', 'upperLimit': '22.89'}, {'value': '17.80', 'groupId': 'OG001', 'lowerLimit': '12.95', 'upperLimit': '22.65'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '20.33', 'groupId': 'OG000', 'lowerLimit': '17.88', 'upperLimit': '22.79'}, {'value': '15.50', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '25.00'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '21.25', 'groupId': 'OG000', 'lowerLimit': '16.87', 'upperLimit': '25.63'}, {'value': '21.00', 'groupId': 'OG001', 'lowerLimit': '-4.41', 'upperLimit': '46.41'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '22.00', 'groupId': 'OG000', 'lowerLimit': '17.03', 'upperLimit': '26.97'}, {'value': '20.30', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '36.82'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D Emotional Well-Being (EWB) is a 6-item subscale score of the total FACIT-D self-assessment that measures a patient\'s emotional well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-24. Higher scores related to better emotional well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle (every 2 weeks).'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '25.85', 'groupId': 'OG000', 'lowerLimit': '24.74', 'upperLimit': '26.96'}, {'value': '23.91', 'groupId': 'OG001', 'lowerLimit': '20.52', 'upperLimit': '27.29'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '21.46', 'groupId': 'OG000', 'lowerLimit': '17.01', 'upperLimit': '25.92'}, {'value': '24.33', 'groupId': 'OG001', 'lowerLimit': '21.30', 'upperLimit': '27.36'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '20.74', 'groupId': 'OG000', 'lowerLimit': '14.07', 'upperLimit': '27.41'}, {'value': '25.60', 'groupId': 'OG001', 'lowerLimit': '23.70', 'upperLimit': '27.50'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '25.09', 'groupId': 'OG000', 'lowerLimit': '22.16', 'upperLimit': '28.03'}, {'value': '25.33', 'groupId': 'OG001', 'lowerLimit': '23.74', 'upperLimit': '26.91'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '23.43', 'groupId': 'OG000', 'lowerLimit': '20.17', 'upperLimit': '26.68'}, {'value': '24.60', 'groupId': 'OG001', 'lowerLimit': '21.23', 'upperLimit': '27.97'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '25.07', 'groupId': 'OG000', 'lowerLimit': '21.71', 'upperLimit': '28.44'}, {'value': '24.29', 'groupId': 'OG001', 'lowerLimit': '19.09', 'upperLimit': '29.49'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '22.19', 'groupId': 'OG000', 'lowerLimit': '15.33', 'upperLimit': '29.04'}, {'value': '23.60', 'groupId': 'OG001', 'lowerLimit': '21.90', 'upperLimit': '24.21'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '25.83', 'groupId': 'OG000', 'lowerLimit': '21.76', 'upperLimit': '29.91'}, {'value': '22.89', 'groupId': 'OG001', 'lowerLimit': '19.05', 'upperLimit': '26.73'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '24.22', 'groupId': 'OG000', 'lowerLimit': '19.58', 'upperLimit': '28.87'}, {'value': '21.63', 'groupId': 'OG001', 'lowerLimit': '15.45', 'upperLimit': '27.82'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '25.67', 'groupId': 'OG000', 'lowerLimit': '20.42', 'upperLimit': '30.92'}, {'value': '23.00', 'groupId': 'OG001', 'lowerLimit': '-2.41', 'upperLimit': '48.41'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '24.94', 'groupId': 'OG000', 'lowerLimit': '14.21', 'upperLimit': '35.68'}, {'value': '23.50', 'groupId': 'OG001', 'lowerLimit': '-8.27', 'upperLimit': '55.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D Social Well-Being (SWB) is a 7-item subset score of the total FACIT-D self-assessment that measures a patient\'s social well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better social well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '19.85', 'groupId': 'OG000', 'lowerLimit': '16.48', 'upperLimit': '23.21'}, {'value': '18.07', 'groupId': 'OG001', 'lowerLimit': '14.44', 'upperLimit': '21.70'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '18.89', 'groupId': 'OG000', 'lowerLimit': '14.62', 'upperLimit': '23.17'}, {'value': '17.21', 'groupId': 'OG001', 'lowerLimit': '13.84', 'upperLimit': '20.59'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '19.78', 'groupId': 'OG000', 'lowerLimit': '15.43', 'upperLimit': '24.97'}, {'value': '20.20', 'groupId': 'OG001', 'lowerLimit': '14.46', 'upperLimit': '25.10'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '20.11', 'groupId': 'OG000', 'lowerLimit': '15.59', 'upperLimit': '24.63'}, {'value': '19.32', 'groupId': 'OG001', 'lowerLimit': '14.33', 'upperLimit': '24.30'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '19.44', 'groupId': 'OG000', 'lowerLimit': '15.47', 'upperLimit': '23.42'}, {'value': '19.09', 'groupId': 'OG001', 'lowerLimit': '14.86', 'upperLimit': '23.32'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '19.77', 'groupId': 'OG000', 'lowerLimit': '16.09', 'upperLimit': '23.46'}, {'value': '20.50', 'groupId': 'OG001', 'lowerLimit': '10.56', 'upperLimit': '30.44'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '19.62', 'groupId': 'OG000', 'lowerLimit': '15.48', 'upperLimit': '23.77'}, {'value': '17.00', 'groupId': 'OG001', 'lowerLimit': '10.31', 'upperLimit': '23.69'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '19.00', 'groupId': 'OG000', 'lowerLimit': '12.98', 'upperLimit': '25.02'}, {'value': '16.40', 'groupId': 'OG001', 'lowerLimit': '10.74', 'upperLimit': '22.06'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '19.83', 'groupId': 'OG000', 'lowerLimit': '14.85', 'upperLimit': '24.82'}, {'value': '17.00', 'groupId': 'OG001', 'lowerLimit': '7.19', 'upperLimit': '26.81'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '22.58', 'groupId': 'OG000', 'lowerLimit': '7.19', 'upperLimit': '26.81'}, {'value': '20.50', 'groupId': 'OG001', 'lowerLimit': '14.85', 'upperLimit': '24.82'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '21.00', 'groupId': 'OG000', 'lowerLimit': '-35.68', 'upperLimit': '78.68'}, {'value': '21.50', 'groupId': 'OG001', 'lowerLimit': '2.25', 'upperLimit': '39.75'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D Functional Well-Being (FWB) is a 7-item subscale of the FACIT-D that measures a patient\'s functional well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better family well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan+ KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '88.72', 'groupId': 'OG000', 'lowerLimit': '82.18', 'upperLimit': '95.26'}, {'value': '80.19', 'groupId': 'OG001', 'lowerLimit': '68.66', 'upperLimit': '91.73'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '80.05', 'groupId': 'OG000', 'lowerLimit': '68.46', 'upperLimit': '91.64'}, {'value': '79.98', 'groupId': 'OG001', 'lowerLimit': '69.37', 'upperLimit': '90.58'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '82.47', 'groupId': 'OG000', 'lowerLimit': '69.52', 'upperLimit': '95.42'}, {'value': '84.99', 'groupId': 'OG001', 'lowerLimit': '72.48', 'upperLimit': '97.51'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '89.57', 'groupId': 'OG000', 'lowerLimit': '79.78', 'upperLimit': '99.37'}, {'value': '83.70', 'groupId': 'OG001', 'lowerLimit': '70.54', 'upperLimit': '96.86'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '84.87', 'groupId': 'OG000', 'lowerLimit': '75.61', 'upperLimit': '94.13'}, {'value': '86.33', 'groupId': 'OG001', 'lowerLimit': '76.32', 'upperLimit': '96.33'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '88.85', 'groupId': 'OG000', 'lowerLimit': '78.33', 'upperLimit': '99.36'}, {'value': '85.42', 'groupId': 'OG001', 'lowerLimit': '64.40', 'upperLimit': '106.44'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '85.19', 'groupId': 'OG000', 'lowerLimit': '73.99', 'upperLimit': '96.38'}, {'value': '79.07', 'groupId': 'OG001', 'lowerLimit': '65.44', 'upperLimit': '92.70'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '87.55', 'groupId': 'OG000', 'lowerLimit': '75.96', 'upperLimit': '99.13'}, {'value': '76.43', 'groupId': 'OG001', 'lowerLimit': '60.23', 'upperLimit': '92.62'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '87.06', 'groupId': 'OG000', 'lowerLimit': '74.44', 'upperLimit': '99.67'}, {'value': '74.79', 'groupId': 'OG001', 'lowerLimit': '48.58', 'upperLimit': '101.00'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '91.50', 'groupId': 'OG000', 'lowerLimit': '73.24', 'upperLimit': '109.76'}, {'value': '87.00', 'groupId': 'OG001', 'lowerLimit': '-65.47', 'upperLimit': '239.47'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '91.28', 'groupId': 'OG000', 'lowerLimit': '53.15', 'upperLimit': '129.40'}, {'value': '88.80', 'groupId': 'OG001', 'lowerLimit': '-23.01', 'upperLimit': '200.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The FACIT-D FACTG: FACT-G Total Score is a total of PWB (Physical Well-Being)+SWB (Social Well-Being)+EWB (Emotional Well-Being)+FWB (Functional Well-Being) subset scores. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-108. Higher scores indicate greater well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACT-G during any single treatment cycle.'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '41.39', 'groupId': 'OG000', 'lowerLimit': '36.50', 'upperLimit': '46.28'}, {'value': '36.17', 'groupId': 'OG001', 'lowerLimit': '28.42', 'upperLimit': '43.91'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '36.09', 'groupId': 'OG000', 'lowerLimit': '26.22', 'upperLimit': '45.96'}, {'value': '36.67', 'groupId': 'OG001', 'lowerLimit': '30.36', 'upperLimit': '42.97'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '38.80', 'groupId': 'OG000', 'lowerLimit': '32.68', 'upperLimit': '44.92'}, {'value': '38.45', 'groupId': 'OG001', 'lowerLimit': '30.44', 'upperLimit': '46.47'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '41.67', 'groupId': 'OG000', 'lowerLimit': '36.57', 'upperLimit': '46.77'}, {'value': '36.22', 'groupId': 'OG001', 'lowerLimit': '27.19', 'upperLimit': '45.26'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '40.22', 'groupId': 'OG000', 'lowerLimit': '36.18', 'upperLimit': '44.27'}, {'value': '38.56', 'groupId': 'OG001', 'lowerLimit': '30.64', 'upperLimit': '46.47'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '40.25', 'groupId': 'OG000', 'lowerLimit': '36.02', 'upperLimit': '44.48'}, {'value': '39.75', 'groupId': 'OG001', 'lowerLimit': '23.77', 'upperLimit': '55.73'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '41.53', 'groupId': 'OG000', 'lowerLimit': '36.03', 'upperLimit': '47.03'}, {'value': '30.72', 'groupId': 'OG001', 'lowerLimit': '20.11', 'upperLimit': '41.33'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '41.33', 'groupId': 'OG000', 'lowerLimit': '34.67', 'upperLimit': '47.99'}, {'value': '33.33', 'groupId': 'OG001', 'lowerLimit': '22.74', 'upperLimit': '43.93'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '40.78', 'groupId': 'OG000', 'lowerLimit': '28.92', 'upperLimit': '52.65'}, {'value': '30.20', 'groupId': 'OG001', 'lowerLimit': '14.96', 'upperLimit': '45.44'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '40.25', 'groupId': 'OG000', 'lowerLimit': '29.59', 'upperLimit': '50.91'}, {'value': '33.33', 'groupId': 'OG001', 'lowerLimit': '-1.47', 'upperLimit': '68.14'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '41.50', 'groupId': 'OG000', 'lowerLimit': '30.14', 'upperLimit': '52.86'}, {'value': '40.00', 'groupId': 'OG001', 'lowerLimit': '-36.24', 'upperLimit': '116.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score is a 13 -item self-reporting assessment that measures fatigue related to their illness. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-52. Higher scores indicate better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.'}, {'type': 'SECONDARY', 'title': 'The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan+ KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Cycle 0', 'categories': [{'measurements': [{'value': '82.03', 'groupId': 'OG000', 'lowerLimit': '75.36', 'upperLimit': '88.70'}, {'value': '79.23', 'groupId': 'OG001', 'lowerLimit': '71.42', 'upperLimit': '87.04'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '78.01', 'groupId': 'OG000', 'lowerLimit': '68.39', 'upperLimit': '87.63'}, {'value': '75.17', 'groupId': 'OG001', 'lowerLimit': '66.46', 'upperLimit': '83.89'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '76.56', 'groupId': 'OG000', 'lowerLimit': '62.84', 'upperLimit': '90.27'}, {'value': '82.42', 'groupId': 'OG001', 'lowerLimit': '72.85', 'upperLimit': '91.98'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '81.88', 'groupId': 'OG000', 'lowerLimit': '71.97', 'upperLimit': '91.78'}, {'value': '76.27', 'groupId': 'OG001', 'lowerLimit': '62.73', 'upperLimit': '89.80'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '77.12', 'groupId': 'OG000', 'lowerLimit': '68.15', 'upperLimit': '86.10'}, {'value': '79.11', 'groupId': 'OG001', 'lowerLimit': '67.99', 'upperLimit': '90.23'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '80.40', 'groupId': 'OG000', 'lowerLimit': '67.97', 'upperLimit': '92.82'}, {'value': '73.62', 'groupId': 'OG001', 'lowerLimit': '56.42', 'upperLimit': '90.83'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '79.11', 'groupId': 'OG000', 'lowerLimit': '68.09', 'upperLimit': '90.14'}, {'value': '66.46', 'groupId': 'OG001', 'lowerLimit': '47.02', 'upperLimit': '85.90'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '82.00', 'groupId': 'OG000', 'lowerLimit': '67.33', 'upperLimit': '96.67'}, {'value': '65.40', 'groupId': 'OG001', 'lowerLimit': '47.27', 'upperLimit': '83.53'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '81.25', 'groupId': 'OG000', 'lowerLimit': '55.74', 'upperLimit': '106.76'}, {'value': '61.50', 'groupId': 'OG001', 'lowerLimit': '33.62', 'upperLimit': '89.38'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '80.44', 'groupId': 'OG000', 'lowerLimit': '38.37', 'upperLimit': '122.52'}, {'value': '75.50', 'groupId': 'OG001', 'lowerLimit': '-57.92', 'upperLimit': '208.92'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '68.50', 'groupId': 'OG000', 'lowerLimit': '-1.38', 'upperLimit': '138.38'}, {'value': '76.50', 'groupId': 'OG001', 'lowerLimit': '-44.21', 'upperLimit': '197.21'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index. is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and "additional concerns" subscales of the FACIT-D. The TOI is an efficient summary index of physical/functional outcomes. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score can range from 0-100. Higher scores relate to better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).'}, {'type': 'SECONDARY', 'title': 'Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Scores < 4.8 (two metabolites)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Scores > 4.8 (two metabolites)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Scores < 4.8 (one metabolite+two cytokine)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Scores > 4.8 (one metabolite+two cytokine)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'description': 'Number of patients with metabolites in their blood samples with a score less than 4.8 and greater than 4.8. A Cox Proportional Hazard Regression Analysis was fitted using survival time, status to the cytokines and metabolites as covariates. The analysis computes beta coefficients (hazard ratios) for each cytokine/metabolite. Scores higher than a threshold value of 4.8 were associated with higher overall survival than patients who scored less than 4.8.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that received study treatment.'}, {'type': 'SECONDARY', 'title': 'Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'genotype 5/6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'genotype 6/6', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'genotype 6/7', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'genotype 7/7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 30 minutes prior to irinotecan infusion through to Immediately after irinotecan infusion, up to 8 weeks', 'description': 'The number of patients with specific polymorphisms of UGT1A1 using genotype analysis of peripheral blood sample. UGT1A1\\*1 is the wild-type allele associated with normal enzyme activity. Patients with genotypic status of 7/7 are at an increased risk of neutropenia following intravenous irinotecan therapy.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed at least (3) treatment cycles.'}, {'type': 'SECONDARY', 'title': 'Circulating Tumor DNA - Percentage of Patients With DNA Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan + KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Braf mutation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Kras mutation', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Nras mutation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PIK3CA mutation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'PTEN mutation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline - prior to treatment', 'description': 'Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Circulating Tumor DNA - Percentage of Patients With DNA Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Irinotecan+ KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'OG001', 'title': 'Arm B - Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'classes': [{'title': 'Braf mutation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Kras mutation', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Nras mutation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'PIK3CA mutation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PTEN mutation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment - up to 8 weeks', 'description': 'Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Irinotecan+ KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'FG001', 'title': 'Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Irinotecan+ KD018', 'description': 'KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.\n\nIrinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².'}, {'id': 'BG001', 'title': 'Irinotecan + Placebo', 'description': 'Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².\n\nPlacebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2008-08-04', 'resultsFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2008-08-04', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-29', 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Grade 2-4 Toxicities', 'timeFrame': 'Up to 3 months after start of study treatment', 'description': 'The proportion of participants with a toxicity grade greater than or equal to grade 2, per NCI CTCAE 4.0. Toxicity is defined as any adverse event (AE) at least probably related to treatment occurring with 90 days of the beginning of treatment. The worst grade of AE at least probably related to treatment was determined for each participant.'}], 'secondaryOutcomes': [{'measure': 'Overall Response (OR)', 'timeFrame': 'Up to 36 months', 'description': 'Number of participants who experienced a best response of Partial Response (PR) or Stable Disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), PR is \\>=30% decrease in the sum of the longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameter.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 450 days', 'description': 'Median number of days and after the treatment participants remained alive without worsening disease.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 900 days', 'description': 'Median number of days from the start of treatment that study participants remained alive.'}, {'measure': 'Clinical Response (CR)', 'timeFrame': 'Up to 36 months', 'description': 'Number of patients that experienced Progressed Disease, Stable Disease or Partial Response per RECIST 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters, and Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Functional Assessment of Chronic Illness Therapy (Diarrhea), the FACIT-D, contains 11 items which address concerns related to treatment-related diarrhea. Responses are on a Likert scale and range from 0 = "Not at all" to 4 = "Very Much". Thus, total scores can range from 0 to 44. Higher scores relate to better functioning.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being is a 7-item subscale score of the total FACIT-D self-assessment that measures a patient\'s physical well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better physical well-being.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D Emotional Well-Being (EWB) is a 6-item subscale score of the total FACIT-D self-assessment that measures a patient\'s emotional well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-24. Higher scores related to better emotional well-being.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D Social Well-Being (SWB) is a 7-item subset score of the total FACIT-D self-assessment that measures a patient\'s social well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better social well-being.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D Functional Well-Being (FWB) is a 7-item subscale of the FACIT-D that measures a patient\'s functional well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better family well-being.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)', 'timeFrame': 'Up to 36 months', 'description': 'The FACIT-D FACTG: FACT-G Total Score is a total of PWB (Physical Well-Being)+SWB (Social Well-Being)+EWB (Emotional Well-Being)+FWB (Functional Well-Being) subset scores. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-108. Higher scores indicate greater well-being.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score is a 13 -item self-reporting assessment that measures fatigue related to their illness. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-52. Higher scores indicate better functioning.'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index', 'timeFrame': 'Up to 36 months', 'description': 'The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index. is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and "additional concerns" subscales of the FACIT-D. The TOI is an efficient summary index of physical/functional outcomes. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score can range from 0-100. Higher scores relate to better functioning.'}, {'measure': 'Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression', 'timeFrame': 'Up to 36 months', 'description': 'Number of patients with metabolites in their blood samples with a score less than 4.8 and greater than 4.8. A Cox Proportional Hazard Regression Analysis was fitted using survival time, status to the cytokines and metabolites as covariates. The analysis computes beta coefficients (hazard ratios) for each cytokine/metabolite. Scores higher than a threshold value of 4.8 were associated with higher overall survival than patients who scored less than 4.8.'}, {'measure': 'Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles', 'timeFrame': 'From 30 minutes prior to irinotecan infusion through to Immediately after irinotecan infusion, up to 8 weeks', 'description': 'The number of patients with specific polymorphisms of UGT1A1 using genotype analysis of peripheral blood sample. UGT1A1\\*1 is the wild-type allele associated with normal enzyme activity. Patients with genotypic status of 7/7 are at an increased risk of neutropenia following intravenous irinotecan therapy.'}, {'measure': 'Circulating Tumor DNA - Percentage of Patients With DNA Mutations', 'timeFrame': 'Baseline - prior to treatment', 'description': 'Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.'}, {'measure': 'Circulating Tumor DNA - Percentage of Patients With DNA Mutations', 'timeFrame': 'End of treatment - up to 8 weeks', 'description': 'Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '20720216', 'type': 'DERIVED', 'citation': 'Lam W, Bussom S, Guan F, Jiang Z, Zhang W, Gullen EA, Liu SH, Cheng YC. The four-herb Chinese medicine PHY906 reduces chemotherapy-induced gastrointestinal toxicity. Sci Transl Med. 2010 Aug 18;2(45):45ra59. doi: 10.1126/scitranslmed.3001270.'}]}, 'descriptionModule': {'briefSummary': 'The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of KD018 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.', 'detailedDescription': 'KD018 is an oral form of a spray dried aqueous extract composed of four main herbs, which have been used in the Orient for nearly 2000 years for a variety of GI symptoms including diarrhea and nausea/vomiting. Extensive pre-clinical research has been done with Chinese herbal medicine, and studies have documented significant anticancer activity in combination with various cytotoxic agents including Irinotecan, which is a semi-synthetic derivative of the natural alkaloid camptothecin and belongs to the class of topoisomerase I inhibitors. Irinotecan has been evaluated extensively as a single agent as well as in combination with other cytotoxic agents in several schedules. We recently completed a phase I study of irinotecan using the every-2-week schedule in combination with varying doses of KD018. Based on this phase I study, the dose of irinotecan that will be used in this study is 215 mg/m2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with histologically confirmed metastatic colorectal cancer (mCRC), who have received and/or progressed on a prior oxaliplatin-based chemotherapy regimen.\n2. Patients must have been off of chemotherapy for at least 4 weeks prior to signing the informed consent/start of screening.\n3. Patients with wild-type or mutant KRAS mCRC.\n4. At least one measurable lesion by RECIST 1.1.\n5. ECOG PS Performance Status 0-2.\n6. Must be \\>/=18 years of age.\n7. Expected survival of at least 6 months.\n8. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \\[IUD\\], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods. Pregnant and nursing patients are excluded because the effects of the combination of KD018 and irinotecan on a fetus or nursing child are unknown.\n9. Must be able and willing to give written informed consent.\n10. Patients must have the following clinical laboratory values:\n\n 1. ANC count \\>/= 1,500/ mm3.\n 2. Platelets \\>/= 100,000/ mm3.\n 3. Hemoglobin \\>/= 9 gm/dL (may be corrected by transfusion).\n11. Evidence of adequate hepatic function, Bilirubin \\< 1.5 x upper limit of normal (ULN) AST \\</= 2.5 x ULN or ALT \\</= 2.5 x ULN (Note, if both AST and ALT are done, both must be \\</= 2.5 x ULN) OR AST \\</= 5.0 x ULN or ALT \\</= 5.0 x ULN is acceptable if liver has tumor involvement. (Note, if both AST and ALT are done, both must be \\</= 5.0 x ULN)\n12. Serum creatinine \\</=2 x ULN\n13. Serum potassium within institutional limits of normal (may be corrected with potassium repletion).\n\nExclusion Criteria:\n\n1. Continued treatment with bevacizumab with documented evidence of disease progression on a bevacizumab-containing regimen.\n2. Uncontrolled or symptomatic brain metastasis.\n3. Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.\n4. Unwilling or unable to follow protocol requirements or to give informed consent.\n5. No treatment with cytotoxic or biologic agents within the 4 weeks prior to beginning treatment on this study (6 weeks for mitomycin or nitrosoureas). At least 4 weeks must have elapsed from any prior surgery, radiation, hormonal or other drug therapy for their cancer.\n6. Known HIV positivity, as safety in this patient population has not been assessed.\n7. Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrollment.\n8. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.\n9. Pregnant or breast-feeding women.\n10. Men and women of childbearing age and potential, who are not willing to use effective contraception.\n11. Major surgery within the previous 4 weeks.\n12. Patients taking concurrent medications of any kind which are strong inducers or inhibitors of CYP3A4.\n13. Patients previously treated with an irinotecan-containing regimen."}, 'identificationModule': {'nctId': 'NCT00730158', 'briefTitle': 'A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': '12-005'}, 'secondaryIdInfos': [{'id': 'ACS IRG 58-012-49'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'irinotecan+ KD018', 'interventionNames': ['Drug: KD018', 'Drug: Irinotecan']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'irinotecan + placebo', 'interventionNames': ['Drug: Irinotecan', 'Drug: Placebo']}], 'interventions': [{'name': 'KD018', 'type': 'DRUG', 'description': 'Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.', 'armGroupLabels': ['Arm A']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Camptosar', 'CPT-11'], 'description': 'Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University Comprehensive Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hillman CancerCenters', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Edward Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillman Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward Chu, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kadmon Corporation, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edward Chu, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}