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 @ 11:34 PM
Ignite Modification Date: 2025-12-25 @ 9:23 PM
NCT ID: NCT01168856
Description: Only adverse events (AEs) and serious adverse events (SAEs) related to protocol defined blood sampling procedures were collected.
Frequency Threshold: 0
Time Frame: Up to 36 Months
Study: NCT01168856
Study Brief: An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Resistance Monitoring Arm Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. None None 0 172 1 172 View
SVR Durability Monitoring Arm Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication. None None 0 552 0 552 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VENIPUNCTURE SITE BRUISE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View