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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT01473732
Description: The two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria discontinued everolimus and switched to tacrolimus. The death occurred two months after enrollment. The proteinuria event occurred fours months after enrollment. No patient enrolled in reduced tacrolimus dose group and due to difficulty in enrollment the study is terminated. No data was analyzed for any participant.
Frequency Threshold: 0
Time Frame: The only two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria. The first participant was enrolled in March of 2012 and the study was terminated in August 2012.
Study: NCT01473732
Study Brief: Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Everolimus (Zortress)+ Mycophenolic Acid(Myfortic) Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year. 1 None 2 2 0 2 View
Reduced Dose Prograf+ Mycophenolic Acid(Myfortic) Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Small bowel obstruction leading to death NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):