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: 2025-12-25 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT03567434
Description: Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.
Frequency Threshold: 0
Time Frame: On average 1 to 2 months following initial laboratory testing session
Study: NCT03567434
Study Brief: Alcohol and Neural Cardiovascular Control in Binge Drinkers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluid Control All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout. 0 None 0 38 2 38 View
Alcohol All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout. 0 None 0 38 1 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Presyncope in response to venipuncture SYSTEMATIC_ASSESSMENT Nervous system disorders None View