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 @ 6:52 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT04218357
Description: We reported any of the following Adverse Events: 1. All-Cause Mortality in both conditions (none to report) 2. Serious Adverse Events: in both conditions (none to report) 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within both conditions, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study (none to report)
Frequency Threshold: 5
Time Frame: Adverse events were monitored during two laboratory sessions, visits 2 and 3, at which time probenecid and placebo were administered.
Study: NCT04218357
Study Brief: Probenecid as Medication for Alcohol Use Disorder (PROB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Matching Placebo Placebo, one pill by mouth once, for one day Matching placebo: Placebo 0 None 0 35 0 35 View
Probenecid 2g probenecid, one pill by mouth once, for one day Probenecid: safety 0 None 0 34 0 34 View
Serious Events(If Any):
Other Events(If Any):