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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:08 PM
NCT ID: NCT04885257
Description: None
Frequency Threshold: 0
Time Frame: 12 week study period and the 30 day tapering off methylphenidate/placebo.
Study: NCT04885257
Study Brief: Methylphenidate for Ptsd and Stroke Veterans
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 Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing. Placebo: Placebo arm 0 None 1 10 4 10 View
Methylphenidate Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily. Methylphenidate: Methylphenidate oral pill. Dosing instructions given to 0 None 2 10 1 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to infectious illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gastrointestinal bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Speech abnormality NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View