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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT03332056
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT03332056
Study Brief: The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belladonna and Opium (B&O) Suppository A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain. Belladonna and Opium 0 None 0 35 3 35 View
Placebo Suppository placebo suppository Placebo suppository 0 None 0 34 5 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emergency Department visits SYSTEMATIC_ASSESSMENT General disorders None View