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 @ 12:37 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT03097861
Description: Treatment-related Adverse Events (TRAEs) were any event with possible, probably, or definite relationship with the study medication, and with an onset date on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication. TRAEs were collected in the safety population, defined as all randomized participants who took at least one dose of double-blinded study medication.
Frequency Threshold: 2
Time Frame: from first dose of study medication through a 1-week follow-up (up to 15 days)
Study: NCT03097861
Study Brief: Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days. 0 None 0 143 15 143 View
Lubiprostone Sprinkle Lubiprostone 24 mcg sprinkle BID for 7 days. 0 None 0 275 50 275 View
Lubiprostone Capsule Lubiprostone 24 mcg capsule BID for 7 days. 0 None 0 130 29 130 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View