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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT00100659
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00100659
Study Brief: PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pegylated Interferon/Placebo Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily). None None 1 59 52 59 View
Pegylated Interferon/Ribavirin Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly. Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. None None 2 55 51 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide gesture SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
New onset diabetes mellitus Type 1 SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Complications of a liver biopsy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Joint and muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Trouble sleeping SYSTEMATIC_ASSESSMENT General disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View