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 @ 12:23 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT04169061
Description: All serious adverse events that occurred during the trial are reported, regardless of dosing status. Non-serious treatment-emergent adverse events are included if 5% or more participants had that same event. Participants may have more than one event per system organ class and preferred term. At each level of subject summarization, a participant is counted once if the participant had one or more events.
Frequency Threshold: 5
Time Frame: While participating in the trial (up to 22 weeks)
Study: NCT04169061
Study Brief: Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen 1 None 1 36 2 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (23.0) View