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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT01361633
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored via a standardized side effect check list in the one hour time frame after the single dose administration and prior to neuropsychological testing. No spontaneous adverse events outside of this time frame were reported.
Study: NCT01361633
Study Brief: The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sugar Pill Placebo Control None None 0 23 4 23 View
Medication 250 mg d-cycloserine None None 0 19 3 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Tingling sensation SYSTEMATIC_ASSESSMENT General disorders None View
Feeling lightheaded SYSTEMATIC_ASSESSMENT General disorders None View