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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:20 PM
NCT ID: NCT00945256
Description: Adverse events were self reported by subjects to clinical research staff.
Frequency Threshold: 5
Time Frame: Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Study: NCT00945256
Study Brief: Muscle Perfusion and Protein Metabolism in Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Young Aerobic Exercise 45 minutes of treadmill walking completed at 40% VO2 peak. None None 0 13 0 13 View
Elderly Aerobic Exercise 45 minutes of treadmill walking completed at 40% VO2 peak. None None 0 10 0 10 View
Young Sodium Nitroprusside Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min. None None 0 15 2 15 View
Elderly Sodium Nitroprusside Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min. None None 1 16 2 16 View
Elderly Sodium Nitroprusside and Amino Acid Drink Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally. None None 0 8 0 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Redness at biopsy site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling at femoral catheter site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View