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 @ 6:32 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT02640157
Description: TEAEs and TESAEs are defined as any AE or SAE 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: NCT02640157
Study Brief: A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. None None 5 233 126 233 View
ARM B Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. None None 2 115 53 115 View
ARM C ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. None None 3 157 64 157 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
OPHTHALMIC HERPES SIMPLEX SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.0 View
LIMB INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.19.0 View
POISONING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.19.0 View
PARANASAL SINUS AND NASAL CAVITY MALIGNANT NEOPLASM RECURRENT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v.19.0 View
ABORTION MISSED SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v.19.0 View
SUBSTANCE-INDUCED PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.19.0 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.19.0 View
ULCERATIVE KERATITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.19.0 View
ACCIDENTAL OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.19.0 View
IRON DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v.19.0 View
DEPENDENCE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.19.0 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.19.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.19.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.19.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.19.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.19.0 View