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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT02314403
Description: An adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom, laboratory finding, or disease that occurs during participation in the trial. An adverse event will be followed until it resolves or until 30 days after a participant terminates from the study, whichever comes first.
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT02314403
Study Brief: Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Combined Bone Marrow and Kidney Transplantation Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met. Belatacept: A selective T-cell (lymphocyte) costimulation blocker ATG: A T-Cell Depleting Agent Rituximab: B-Cell Depleting Agent Total Body Irradiation Thymic Irradiation Combined Bone Marrow/Kidney Transplantation 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombotic Microangiopathy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HSV Lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Heel pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View