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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:31 PM
NCT ID: NCT00743093
Description: None
Frequency Threshold: 1
Time Frame: Adverse events were collected starting at the time of consent through study completion.
Study: NCT00743093
Study Brief: Aminotransferase Trends During Prolonged Acetaminophen Dosing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acetaminophen Arm acetaminophen acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days. None None 0 224 147 224 View
Placebo Arm placebo placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days None None 0 52 25 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear and labyrinth disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Muskuloskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View