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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT01552369
Description: Liver transplant recipients represent a population in whom a high rate of medical events are commonly seen during the post-transplant course. For this study, adverse events were: Any clinically important untoward medical occurrence in a subject receiving study drug that is different from what is expected in the clinical course of a patient with a liver transplant. Any clinically important, untoward medical occurrence thought to be related to the study drug, regardless of 'expectedness'.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01552369
Study Brief: CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Preemptive Therapy 900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. 12 None 2 100 1 100 View
Prophylaxis 900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction. 7 None 0 105 1 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Kidney stone NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View