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 @ 12:53 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT00772967
Description: AEs were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Frequency Threshold: 5
Time Frame: Adverse experiences (AEs) were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed.
Study: NCT00772967
Study Brief: A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
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 treated with at least one dose of Placebo None None 0 22 0 22 View
Naproxen Participants treated with at least one dose of Naproxen None None 0 22 0 22 View
Ultracet Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation. None None 0 20 2 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View