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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT03373435
Description: Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
Frequency Threshold: 5
Time Frame: 3 Months
Study: NCT03373435
Study Brief: Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Avexitide 30 mg BID patients (treatment group 1 + treatment 2) received 30 mg twice a day 0 None 0 18 3 18 View
Avexitide 60 mg QD patients (treatment group 1 + treatment group 2)) received 60 mg once a day. 0 None 1 18 9 18 View
Placebo Patients received placebo in treatment period 1 (initial 14 days) in the study. 0 None 0 18 14 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View