Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:41 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT01085903
Description: Adverse Events were recorded in a cumulative fashion for stroke participants, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT01085903
Study Brief: Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal Subjects Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions. Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. Follow up: Follow up testing occurred at 3 months None None 0 21 1 21 View
Stroke Subjects Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. Follow up: Follow up testing occurred at 3 months None None 2 7 6 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
broken hip NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vasovagal response NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
difficulty sleeping NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View