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 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT01732718
Description: None
Frequency Threshold: 0
Time Frame: Beginning with the first intervention and throughout washout and second intervention and then for 4 weeks after end of treatment
Study: NCT01732718
Study Brief: Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell 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
Atorvastatin Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention 0 None 1 13 7 13 View
Placebo Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention 0 None 3 13 6 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain Crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heart Palpitations and Fainting NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza B NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headaches/Head Pressure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain Crisis Treated at Home NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dry Skin NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema of Lower Extremity NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Leg Ulcer NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Low O2 Saturation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea and Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Low ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Axillary Adenopathy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Wrist Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View