Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT00425802
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT00425802
Study Brief: Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL). 9 None 26 61 59 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever (in the absence of neutropenia) SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection - catheter related SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death Not Otherwise Specified SYSTEMATIC_ASSESSMENT General disorders None View
Death not assoc w CTCAE term - Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection, other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucositis - oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurology - other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ocular/visual - other SYSTEMATIC_ASSESSMENT Eye disorders None View
Ophthalmoplegia/Diplopia (double vision) SYSTEMATIC_ASSESSMENT Eye disorders None View
Lymphocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain - oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate Aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Infection, other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View