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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT00896493
Description: None
Frequency Threshold: 0
Time Frame: Up to 5 years
Study: NCT00896493
Study Brief: Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg. 21 None 7 38 20 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Secondary Malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Secondary Malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Acute Viral Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Liver Failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
GI Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Acute appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Serum sickness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Disease Relapse SYSTEMATIC_ASSESSMENT General disorders None View
Secondary Malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection, non-specified SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Post transplant lymphoproliferative disorder (PTLD) SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
EBV viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View