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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT02725866
Description: TEAEs and TESAEs are defined as any adverse event (AE) 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: 0
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 28 weeks).
Study: NCT02725866
Study Brief: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants With HCV Genotype 1 or 4 Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks 0 None 7 216 21 216 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Substance use SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Substance use SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View