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 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:02 AM
NCT ID: NCT00589602
Description: None
Frequency Threshold: 0
Time Frame: Adverse events data was over the course of the study for approximately 7 years
Study: NCT00589602
Study Brief: T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
T-Cell Depletion Transplant peripheral blood lymphocyte therapy: T-cell depletion cyclophosphamide: T-cell depletion tacrolimus: T-cell depletion allogeneic hematopoietic stem cell transplantation: T-cell depletion peripheral blood stem cell transplantation: T-cell depletion total-body irradiation: T-cell depletion None None 9 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death by Relapse NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Death from Acute GVHD NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Death due to respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Death due to Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalized for chest pains NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Hospitalization for fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for broken leg NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized with hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Hospitalized with GVHD NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized with mental status changes NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Hospitalized with Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hospitalized for Nausae, Vomiting and Diarrhea NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hospitalized for shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hospitalized for hypertension NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for Syncope and dizziness NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hospitalized for puritus and plolyarthagias NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hospitalized for abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hospitalized for blood in stool and NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hospitalized for TTP (Thrombotic Thrombocytopenic Purpura) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hospitalized for muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Hospitalized for relapse of disease NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for a motor vehicle accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Hospitalized for necrosis of knees NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Hospitalized for knee replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (3.0) View
Hospitalized for numbness in hands and feet NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hospitalized for surgery medial epicondylitis NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (3.0) View
Hospitalized for mucocitus and rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hospitalized for dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View