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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT01822535
Description: None
Frequency Threshold: 0
Time Frame: Throughout the entire study, i.e. 2011-2015, adverse events (AEs) were reported within 5 business days to the Institutional Review Board (IRB) via an AE form and included on the AE log on the annual continuing review application to comply with IRB policy.
Study: NCT01822535
Study Brief: Body Temperature in Persons With Tetraplegia When Exposed to Cold
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug: Tetraplegia Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug) None None 1 11 0 11 View
No Drug: Able-bodied Age- and gender-matched to individuals with tetraplegia. None None 0 13 0 13 View
No Drug: Tetraplegia Lesion level C3-T1, ASIA levels A and B, ages 18-68 years None None 1 17 1 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Autonomic Dysreflexia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View