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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT02745535
Description: \\Participants were assessed for adverse events at every follow up visit. Adverse events were monitored from the time of informed consent until last study visit.
Frequency Threshold: 5
Time Frame: Adverse events were monitored and reported from day first dose of study medication was taken until 30 days after last dose, which was an average of 16 weeks.
Study: NCT02745535
Study Brief: Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SOF/VEL/VOX Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks in participants with chronic hepatitis c previously exposed to direct acting antivirals (DAA). 1 None 12 77 75 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Glucose level >250mg/dL SYSTEMATIC_ASSESSMENT Investigations None View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypertensive stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary hypertension, exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subderal hematoma, traumatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Aspartate aminotransferase >5xULN SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine >2x baseline SYSTEMATIC_ASSESSMENT Investigations None View
INR >2x ULN SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View