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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT01012492
Description: Attribution of adverse events when patients are co-enrolled on other trials: because abatacept's effects are strictly immunologic and because co-enrollment will only be allowed in trials testing agents without immunomodulatory effects, all adverse events stemming directly or indirectly from immune deficiency or immune dysregulation will be attributed (definite, probable or possible depending on the circumstances) to abatacept and not the agent being tested in the other trial.
Frequency Threshold: 0
Time Frame: One year post-transplant.
Study: NCT01012492
Study Brief: Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abatacept In this trial, we will test the safety and tolerability of the addition of the CD28-B7 blockade agent, abatacept, as an adjunctive therapy for the prevention of GvHD in a high-risk BMT cohort. Four doses of abatacept will be given according to a dosing schedule based on previous trials using CD28-B7 blockade with belatacept in kidney transplantation. Pharmacokinetic and pharmakodynamic analysis of abatacept will be undertaken, as well as an evaluation of the incidence and severity of acute GvHD in this patient cohort. Dosage: Abatacept is administered as an intravenous infusion under medically controlled conditions. Dose is 10mg/kg with a maximum dose of 1 gram. Abatacept should be administered as a 30-minute intravenous infusion. In this study, abatacept will be dosed on days -1, +5, +14, +28 post-transplant. Small adjustments in dose to accommodate abatacept vial size may be acceptable. These dose adjustments must be approved by the study PI. None None 7 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Bacteremia with coagulase negative staphylococcus NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Upper Respiratory Infection - Parainfluenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Bacteremia with E. coli NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Upper Respiratory Infection - Rhinovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Perianal cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Hemorrhagic cystitis with BK virus NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Polyclonal lymphoproliferative disorder NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Renal toxicity NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Bladder toxicity NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View