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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT03456102
Description: No patients were enrolled in Study Arms 3 and 4 due to early termination.
Frequency Threshold: 0
Time Frame: Up to 5 months.
Study: NCT03456102
Study Brief: Statin Adjunctive Therapy for TB
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pravastatin 40 mg Pravastatin 40 mg, isoniazid 300 mg, rifampin 450 mg (weight \<50 kg) or 600 mg (weight \>50 kg), pyrazinamide 20-25 mg/kg, and ethambutol 15-20 mg/kg daily for 14 days Pravastatin: Phase IIB clinical trial: A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. 0 None 4 10 5 10 View
Pravastatin 80 mg Pravastatin 80 mg, isoniazid 300 mg, rifampin 450 mg (weight \<50 kg) or 600 mg (weight \>50 kg), pyrazinamide 20-25 mg/kg, and ethambutol 15-20 mg/kg daily for 14 days Arm 2 will only be recruited if pravastatin 40 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin. Pravastatin: Phase IIB clinical trial: A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. 0 None 1 6 3 6 View
Pravastatin 120 mg Pravastatin 120 mg, isoniazid 300 mg, rifampin 450 mg (weight \<50 kg) or 600 mg (weight \>50 kg), pyrazinamide 20-25 mg/kg, and ethambutol 15-20 mg/kg daily for 14 days Arm 3 will only be recruited if pravastatin 80 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin. Pravastatin: Phase IIB clinical trial: A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. 0 None 0 0 0 0 View
Pravastatin 160 mg Pravastatin 160 mg, isoniazid 300 mg, rifampin 450 mg (weight \<50 kg) or 600 mg (weight \>50 kg), pyrazinamide 20-25 mg/kg, and ethambutol 15-20 mg/kg daily for 14 days Arm 4 will only be recruited if pravastatin 120 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin. Pravastatin: Phase IIB clinical trial: A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated Uric Acid SYSTEMATIC_ASSESSMENT Investigations None View
Elevated liver enzymes (ALT/AST) SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated liver enzymes (ALT/AST) SYSTEMATIC_ASSESSMENT Investigations None View
Elevated creatinine kinase SYSTEMATIC_ASSESSMENT Investigations None View
Elevated uric acid SYSTEMATIC_ASSESSMENT Investigations None View
Decreased hemoglobin level SYSTEMATIC_ASSESSMENT Investigations None View