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: 2025-12-25 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT01172418
Description: Total Numbers at Risk for Serious Adverse Events (100+100=200) and Other Adverse Events (75+70=145) were inconsistent, because in order to determine how many study participants developed NODAT (new onset diabetes after transplant), study participants having pre-transplant diabetes (25 in Groups I, and 30 in Group II) were excluded.
Frequency Threshold: 0
Time Frame: None
Study: NCT01172418
Study Brief: Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Thymoglobulin and Alemtuzumab Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used. Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction. None None 25 100 8 70 View
Thymoglobulin and Daclizumab Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls) Daclizumab: used in combination with Thymoglobulin as combined induction None None 29 100 8 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Patients who developed an infection that required hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
occurrence of NODAT in patients without pretransplant diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View