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 @ 6:59 PM
Ignite Modification Date: 2025-12-25 @ 4:31 PM
NCT ID: NCT03180957
Description: No related grade 3+ AEs were reported during the follow-up for this trial
Frequency Threshold: 5
Time Frame: Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
Study: NCT03180957
Study Brief: Repurposing Anti-TNF for Treating Dupuytren's Disease
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 Saline Saline 0 None 1 70 9 70 View
Anti-TNF Adalimumab Adalimumab 0 None 0 70 9 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse Events SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Adverse event SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View