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 @ 7:51 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT01378104
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01378104
Study Brief: 100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
100% Dosage Group of Peginterferon Alfa 2a These group patients would be treated with standard dose 180 ug/week for 48 weeks. peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose. None None 0 92 45 92 View
80% Dosage Group of Peginterferon Alfa 2a This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable None None 0 86 49 86 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
laboratory adverse events SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CBC View