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 @ 9:11 PM
Ignite Modification Date: 2025-12-25 @ 7:00 PM
NCT ID: NCT01509404
Description: None
Frequency Threshold: 0
Time Frame: up to 2 years
Study: NCT01509404
Study Brief: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Valcyte valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant 1 None 4 20 16 20 View
Valcyte Then Cytogam valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant Valganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant 0 None 4 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CMV disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Graft loss SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
BK infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute rejection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View