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 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:19 PM
NCT ID: NCT05036369
Description: None
Frequency Threshold: 1
Time Frame: The Safety reporting conducted throughout the treatment period (8 weeks)
Study: NCT05036369
Study Brief: Vibrant Capsule vs. Placebo for Patient Suffering From Constipation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Capsule The Vibrant non-biodegradable capsule administrated twice a week Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday). 0 None 0 44 16 44 View
Placebo The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday) 0 None 1 56 11 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalized due to bleeding from the catheter port NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensation of Vibration SYSTEMATIC_ASSESSMENT Product Issues None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Esophageal Spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View