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: 2025-12-25 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT00437294
Description: Study-specific clinical outcomes due to progressive disease (PD) were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
Frequency Threshold: 5
Time Frame: Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
Study: NCT00437294
Study Brief: Enzastaurin in Combination of Capecitabine to Treat Breast 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
A - Capecitabine + Enzastaurin Capecitabine: 1250 milligrams per square meter (mg/m\^2) twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease. None None 12 42 38 42 View
B - Capecitabine + Placebo Capecitabine: 1250 mg/m\^2 BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Placebo: 4 tablets orally, daily, to complete 21-day cycles until progressive disease. None None 12 43 40 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 12.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 12.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 12.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders 12.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 12.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 12.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations 12.0 View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 12.0 View
Biopsy SYSTEMATIC_ASSESSMENT Investigations 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 12.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 12.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 12.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations 12.0 View
Urine colour abnormal SYSTEMATIC_ASSESSMENT Investigations 12.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 12.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 12.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders 12.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 12.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations 12.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations 12.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 12.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 12.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 12.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 12.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 12.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 12.0 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 12.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 12.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 12.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 12.0 View
Skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 12.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 12.0 View