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 @ 11:46 PM
Ignite Modification Date: 2025-12-25 @ 9:39 PM
NCT ID: NCT02813551
Description: Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT02813551
Study Brief: ToRsemide for pOstpartum HYpertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Torsemide Torsemide 20 mg daily for 5 days 0 None 0 59 2 59 View
Placebo Placebo 20 mg daily for 5 days 0 None 0 59 4 59 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased breast milk SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Hypokalemia (low blood potassium levels) SYSTEMATIC_ASSESSMENT General disorders None View