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 @ 6:49 PM
Ignite Modification Date: 2025-12-25 @ 4:21 PM
NCT ID: NCT01813357
Description: Standard definitions used
Frequency Threshold: 5
Time Frame: Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks).
Study: NCT01813357
Study Brief: Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
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 sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding 0 None 6 40 29 40 View
Rosuvastatin Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily 1 None 7 44 36 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Oesophageal Malignancy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lumbar vertebral disc herniation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Type two diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Mesentric Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
elevated creatinine kinase SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Alanine aminotransferase (ALT) SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CK elevation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-specific gastrointestinal disturbance NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ALT elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View