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 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT02605304
Description: At entry, all diagnoses, signs/symptoms and laboratory values were collected, regardless of grade. Post-entry, diagnoses, signs/symptoms and laboratory values of ≥Grade 3 and events that led to change in treatment (excluding indications for RBV dose modifications) or that met ICH, expedited AE, or SAE guidelines, regardless of grade, were collected. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (V2.0) and Expedited AE Manual (V2.0) were used.
Frequency Threshold: 5
Time Frame: From study treatment dispensation to study completion (Week 36 in Arm A, Week 48 in Arm B).
Study: NCT02605304
Study Brief: 12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
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: LDV/SOF + RBV Ledipasvir/sofosbuvir + ribavirin for 12 weeks, followed by 24 weeks of post-treatment follow-up. 0 None 0 4 2 4 View
Arm B: LDV/SOF Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up. 0 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood alkaline phosphatase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View