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: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT04732000
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT04732000
Study Brief: Oxidative Stress and Surgical Recovery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
N-acetyl Cysteine N-acetyl cysteine intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours to an accumulated total of 100 mg/kg over 4 hours. 0 None 0 13 6 13 View
Normal Saline Normal Saline intravenous infusion at a time and rate to mimic the active treatment given over 4 hours beginning during the clinically indicated surgery. 0 None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intestinal Cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever (≥37.2 C) SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Swelling of surgical leg and foot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blisters above right hip SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chills SYSTEMATIC_ASSESSMENT Investigations None View
Rash at site of regional anesthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Full body rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hb ≤6.4 g/dL SYSTEMATIC_ASSESSMENT Investigations None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View