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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT01301066
Description: None
Frequency Threshold: 1.6
Time Frame: None
Study: NCT01301066
Study Brief: A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pitavastatin 4 mg QD Pitavastatin: Pitavastatin 4 mg QD None None 7 126 10 126 View
Pravastatin 40 mg QD Pravastatin: Pravastatin 40 mg QD None None 3 126 5 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Arteriosclerosis coronary artery None Cardiac disorders None View
Atrial septal defect None Cardiac disorders None View
Cerebrovascular accident None Nervous system disorders None View
Chest pain None Cardiac disorders None View
Diverticulitis None Gastrointestinal disorders None View
Enterovesical fistula None Gastrointestinal disorders None View
Gastroenteritis None Gastrointestinal disorders None View
Gastroenteritis viral None Gastrointestinal disorders None View
Herpes dermatitis None Infections and infestations None View
Multiple fractures None Musculoskeletal and connective tissue disorders None View
Muscle haemorrhage None Musculoskeletal and connective tissue disorders None View
Myocardial infarction None Cardiac disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Transient ischaemic attack None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue None General disorders None View
Headache None General disorders None View
Upper abdominal pain None Gastrointestinal disorders None View
Blood CK increased None Blood and lymphatic system disorders None View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View