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 @ 1:53 PM
Ignite Modification Date: 2025-12-25 @ 12:43 PM
NCT ID: NCT02636595
Description: TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).
Study: NCT02636595
Study Brief: The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ABT-493/ABT-530 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. None None 1 121 59 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View