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 @ 1:28 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT01440595
Description: None
Frequency Threshold: 5
Time Frame: Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.
Study: NCT01440595
Study Brief: Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Grazoprevir 400 mg + Peg-IFN + RBV Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks. None None 0 2 2 2 View
Placebo + Peg-IFN + RBV Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks. None None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 15.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 15.1 View
Irritabilty SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 15.1 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 15.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 15.1 View
Skeletal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v. 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v. 15.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v. 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v. 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v. 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 15.1 View
Restless leg syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v. 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v. 15.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 15.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 15.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 15.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 15.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v. 15.1 View