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 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT00855920
Description: Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of dosing \[Day 1\] of study drug up to 35 days after the dose of study medication). Analysis was performed on safety population that included all participants who received any study drug and were analyzed according to the treatment actually received (as treated).
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 31) regardless of seriousness or relationship to investigational product.
Study: NCT00855920
Study Brief: Study Utilizing Rilonacept in Gout Exacerbations
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 (for Rilonacept) and Indomethacin Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo \[for Rilonacept\] and Indomethacin and analyzed in this arm. None None 0 77 8 77 View
Rilonacept and Indomethacin Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo \[for Rilonacept\] and Indomethacin and analyzed in arm (Placebo \[for Rilonacept\] and Indomethacin). None None 3 73 7 73 View
Rilonacept and Placebo (for Indomethacin) Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days. None None 0 75 7 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (12.0) View
Pyoderma gangrenosum SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View