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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT00276250
Description: All adverse events will be recorded, regardless of the severity or relationship to study medication or procedure unless otherwise stated in the CIT-TCAE v. 3.0. Subjects experiencing adverse events will be treated appropriately and observed at suitable intervals until the events resolve or stabilize.
Frequency Threshold: 5
Time Frame: Adverse events data will be collected from the point of islet transplantation throughout the duration of study participation, an average of 2 years.
Study: NCT00276250
Study Brief: Islet Transplantation Using Abatacept
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 Regimen Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received abatacept immunosuppresion regimen after islet-cell transplantation. None None 0 1 1 1 View
Belatacept Regimen Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation. None None 0 0 0 0 View
Efalizumab Followed by Abatacept Regimen Participants with Type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants. None None 2 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever with cough and chills None Infections and infestations None View
Vertigo None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Diarrhea None Gastrointestinal disorders None View
Elevated Liver Enzymes None Hepatobiliary disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Increased Epstein-Barr Viral load assessed by Polymerase Chain Reaction None Infections and infestations None View