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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT02642432
Description: TEAEs and TESAEs are defined as any AE or SAE event with an onset date that is 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: NCT02642432
Study Brief: A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
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 11 146 63 146 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
OESOPHAGEAL VARICES HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
ENDOPHTHALMITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
RECTAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
TUMOUR MARKER INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
HEPATOCELLULAR CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (19.0) View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
ALCOHOL ABUSE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 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