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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:10 PM
NCT ID: NCT02376257
Description: Adverse events were assessed by open query
Frequency Threshold: 5
Time Frame: Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Study: NCT02376257
Study Brief: Improving Therapeutic Learning in Depression: Proof of Concept
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
250 mg DCS Randomized drug intervention was administered on two weekly sessions following baseline evaluation 250 mg DCS: Drug 0 None 0 13 4 13 View
100 mg Modafinil Randomized drug intervention was administered on two weekly sessions following baseline evaluation 100 mg Modafinil: Drug 0 None 0 12 7 12 View
Placebo Randomized drug intervention was administered on two weekly sessions following baseline evaluation Placebo: Drug 0 None 0 11 7 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased Energy/Concentration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue/Low Motivation NON_SYSTEMATIC_ASSESSMENT General disorders None View