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 @ 12:13 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT01266161
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01266161
Study Brief: Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
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 Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours None None 0 52 23 52 View
Ibuprofen Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours None None 0 54 8 54 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Flushing NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Skin burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View