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 @ 5:06 PM
Ignite Modification Date: 2025-12-25 @ 2:45 PM
NCT ID: NCT02912650
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT02912650
Study Brief: A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of 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
Placebo Participants received Placebo as a single oral dose caplet during the study of 12 hours. None None 0 56 19 56 View
Ibuprofen 250 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study. None None 0 172 21 172 View
Ibuprofen 250 mg Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study. None None 0 175 37 175 View
Acetaminophen 650 mg Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study. None None 0 165 41 165 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View