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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT02582632
Description: A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug).
Study: NCT02582632
Study Brief: A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks None None 2 166 70 166 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab 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
NASOPHARYNGITIS 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