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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT02609659
Description: TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
Study: NCT02609659
Study Brief: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus 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
3-DAA + RBV 600 mg 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks. None None 3 105 53 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CYCLIC VOMITING SYNDROME SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
BIPOLAR I DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View
PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) 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
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (19.0) View