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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT02379156
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy. Adverse event data were collected through study completion, up to 14 days.
Study: NCT02379156
Study Brief: Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Able-bodied Cool Temperature Exposure Subjects are able-bodied persons, ages 18-65 years matched for age and gender to the SCI group. Procedure is exposure to cool temperature (64° F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance (Visit 1). Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (BP, HR, Tcore) and tolerance (comfort). 0 None 0 15 0 15 View
SCI Cool Temperature Exposure The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours. Visit 1 (120 minutes, SCI Cool Temperature Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance. 0 None 0 14 0 14 View
SCI Cool Temperature Exposure With Midodrine The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours. In Visit 2 (120 minutes, SCI Cool Temperature Exposure With Midodrine), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance. 0 None 0 14 0 14 View
Serious Events(If Any):
Other Events(If Any):