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 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:37 PM
NCT ID: NCT02889393
Description: None
Frequency Threshold: 0
Time Frame: Up to 19 months
Study: NCT02889393
Study Brief: Teduglutide for Enterocutaneous Fistula (ECF)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
On Teduglutide The study is a crossover design. All participants received 8 weeks of daily Teduglutide. Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. 0 None 0 6 6 6 View
On Standard of Care The study is a crossover design. All participants received 8 weeks of daily Standard of Care Therapy. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stoma hypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain at fistula site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Leg Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lip Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right Sided Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Small Bleeding from Fistula SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
IV Infiltration SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Edema around ostomy site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View