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: 2025-12-25 @ 4:01 AM
Ignite Modification Date: 2025-12-26 @ 2:55 AM
NCT ID: NCT00293202
Description: Adverse Event collected was in the same category as defined
Frequency Threshold: 1
Time Frame: 12 months
Study: NCT00293202
Study Brief: Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Saline injection twice a week Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week 0 None 3 5 1 5 View
Etanercept Etanercept 25 mg injection twice a week Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week 0 None 0 5 1 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
CABG SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cold symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Hematuria, chest pain, nausea and vomiting SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View