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 @ 2:13 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT00885495
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00885495
Study Brief: Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rosuvastatin Rosuvastatin 10 mg daily x 7 days None None 0 14 4 14 View
Darunavir, Ritonavir and Rosuvastatin Darunavir 600 mg and Ritonavir 100 mg twice daily with Rosuvastatin 10 mg daily x 7 days None None 0 12 4 12 View
Darunavir+Ritonavir Darunavir 600 mg and ritonavir 100 mg twice daily x 7 days None None 0 15 6 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Elevated AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated CPK SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View