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 @ 12:29 AM
Ignite Modification Date: 2025-12-25 @ 10:35 PM
NCT ID: NCT02910167
Description: During the observational period, all adverse events following exposure to Buscapina Compositum N were recorded in the case report form, regardless of seriousness or causality.
Frequency Threshold: 5
Time Frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Study: NCT02910167
Study Brief: Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Buscapina Compositum N Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water). 0 None 0 360 0 360 View
Serious Events(If Any):
Other Events(If Any):