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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT01927120
Description: None
Frequency Threshold: 0
Time Frame: 2 years, 6 months
Study: NCT01927120
Study Brief: In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GVHD Regimen Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT). None None 11 20 4 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Colonic hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hepatobiliary disorders - Other, VOD NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Cystitis non-infective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Renal and urinary disorders - Other, adenovirus cystitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Renal and urinary disorders - Other, kidney stones NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Portal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Infections and infestations - Other, pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, staphylococcus epidermis bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Intracranial hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hepatobiliary disorders - Other, portal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View