Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:22 PM
Ignite Modification Date: 2025-12-25 @ 2:57 PM
NCT ID: NCT00433550
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00433550
Study Brief: Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 2 (6/7 UGT1A1 Genotype) Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15 None None 6 10 10 10 View
Group 3 (7/7 UGT1A1 Genotype) Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15 None None 1 6 6 6 View
Group 1 (6/6 UGT1A1 Genotype) Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15 None None 7 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophageal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Gastric infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Laryngeal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Ureteric obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hemorrhage nasal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Peripheral ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View