Adverse Events Module

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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 @ 5:33 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT00437268
Description: Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Frequency Threshold: 5
Time Frame: Baseline to study completion (Cycle 31.5 [21 days/cycle] and 30-day safety follow-up)
Study: NCT00437268
Study Brief: A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Participants With Colorectal 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
Enzastaurin+Irinotecan+Cetuximab Enzastaurin: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1, then 500 mg orally, daily, of each 21-day cycle until progressive disease Irinotecan: 300 milligrams per square meter (mg/m\^2), intravenously on Day 1 of each 21-day cycle until progressive disease Cetuximab: 400 mg/m\^2 intravenously on Day 1, then 250 mg/m\^2 on Days 8 and 15 of Cycle 1, then 250 mg/m\^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease None None 8 13 13 13 View
Irinotecan+Cetuximab Irinotecan: 300 mg/m\^2 intravenously on Day 1 of each 21-day cycle until progressive disease Cetuximab: 400 mg/m\^2 intravenously on Day 1, then 250 mg/m\^2 on Days 8 and 15 in Cycle 1, then 250 mg/m\^2 intravenously on Days 1, 8 and 15 of each 21-day cycle until progressive disease None None 6 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 16.0 View
Anorectal cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 16.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders 16.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 16.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 16.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 16.0 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 16.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 16.0 View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders 16.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders 16.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Breath odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Rectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 16.0 View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 16.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Carcinoembryonic antigen increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations 16.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 16.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 16.0 View
Oral neoplasm benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 16.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 16.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders 16.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 16.0 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders 16.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 16.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 16.0 View
Urinary bladder haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders 16.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders 16.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Rhinalgia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 16.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 16.0 View