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 @ 12:16 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT01680861
Description: Here, we are reporting the numbers of patients who 1) developed an infection requiring hospitalization (or had an opportunistic viral infection not requiring hospitalization) and 2) developed NODAT (new onset diabetes after transplant) (among patients not having pretransplant diabetes mellitus) during the first 12 months post-transplant. Please note that adverse events specified to be studied as secondary outcomes were the only AEs collected in our randomized trial.
Frequency Threshold: 1
Time Frame: during the first 12 months post-transplant,
Study: NCT01680861
Study Brief: Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tacrolimus/Everolimus our experimental maintenance arm None None 4 15 0 15 View
Tacrolimus/EC-MPS our standard maintenance arm None None 4 15 0 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection Requiring Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear Infection Requiring Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV Viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Polyoma Viral Infection (Viremia) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Zoster Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
NODAT SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):