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 @ 5:59 PM
Ignite Modification Date: 2025-12-25 @ 3:21 PM
NCT ID: NCT01984268
Description: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
Frequency Threshold: 0
Time Frame: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
Study: NCT01984268
Study Brief: ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Entire Study The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):