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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT00714493
Description: None
Frequency Threshold: 5
Time Frame: All untoward events occurring between the time of obtaining informed consent through Week 30 or early termination were collected, regardless of causality.
Study: NCT00714493
Study Brief: RESTART C0168Z05 Rheumatoid Arthritis Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infliximab Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response None None 10 203 54 203 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Acute Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrioventricular Block Complete NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiogenic Shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Congestive Cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Multi-Organ Failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Diabetes Mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Rheumatoid Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Metastatic Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Completed Suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View