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: 2025-12-26 @ 12:14 PM
Ignite Modification Date: 2025-12-26 @ 12:14 PM
NCT ID: NCT00135200
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00135200
Study Brief: Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bexxar Therapeutic The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose. None None 3 16 15 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection with Normal Neutrophil Count None Infections and infestations None View
Infection wtih Unknown Neutrophil Count None Infections and infestations None View
Neuropathy - Motor None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin None Blood and lymphatic system disorders None View
Leukocytes (total WBC) None Blood and lymphatic system disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Neutrophils/granulocytes (ANC/AGC) None Blood and lymphatic system disorders None View
Platelets None Blood and lymphatic system disorders None View
Fatigue (asthenia, lethargy, malaise) None General disorders None View
Rash/desquamation None Skin and subcutaneous tissue disorders None View
Diarrhea None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils None Infections and infestations None View
Phosphate, serum-low (hypophosphatemia) None Metabolism and nutrition disorders None View
Pain - Other None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View