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: 2025-12-26 @ 11:12 PM
Ignite Modification Date: 2025-12-26 @ 11:12 PM
NCT ID: NCT04018612
Description: An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
Frequency Threshold: 0
Time Frame: Up to 7 days (± 2 days)
Study: NCT04018612
Study Brief: A Study of Acetaminophen for Post Surgical Dental Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Dose APAP Acetaminophen (APAP) administered post-operatively at a high dose 0 None 0 44 9 44 View
Low Dose APAP Acetaminophen (APAP) administered post-operatively at a low dose 0 None 0 44 13 44 View
Placebo Placebo given post-operatively 0 None 0 22 7 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.0 View
Hypoaesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22.0 View
Infusion site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 22.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.0 View