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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT00874432
Description: There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
Frequency Threshold: 0
Time Frame: up to 12 months
Study: NCT00874432
Study Brief: Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chronic Kidney Disease-ACE-I ace inhibitor lisinopril: 1 x 40 mg per day 0 None 0 8 2 8 View
Chronic Kidney Disease angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day 0 None 0 4 1 4 View
Age Matched Control-ACE-I ace-inhibitor lisinopril: 1 x 40 mg per day 0 None 0 17 3 17 View
Age Matched Control Placebo angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day 0 None 0 14 1 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lip Parasthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Uticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Stiff Neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Blood Pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dry Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View