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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT03557658
Description: None
Frequency Threshold: 5
Time Frame: The adverse event data were collected from Day 0 up to Day 16 after drug administration
Study: NCT03557658
Study Brief: Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal Hepatic Function Healthy subjects with normal hepatic function. Each subject will receive a single oral dose of bexagliflozin, 20 mg. 0 None 0 8 2 8 View
Moderate Hepatic Impairment Subjects with hepatic impairment conforming to the Child-Pugh class B (total score 7-9). Each subject will receive a single oral dose of bexagliflozin tablet, 20 mg 0 None 0 8 3 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View