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: 2025-12-24 @ 4:53 PM
Ignite Modification Date: 2025-12-25 @ 2:36 PM
NCT ID: NCT00492050
Description: None
Frequency Threshold: 1
Time Frame: From the first dose through 30 days after the last dosage up to 5 years
Study: NCT00492050
Study Brief: Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Bortezomib 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily). Bortezomib: 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab: 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily) 0 None 14 37 14 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated Alkaline Phosphate SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gram negative bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophenic fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary nodules SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Spetic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Visual changes SYSTEMATIC_ASSESSMENT General disorders None View
Hyperviscosity SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain (joint) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain (muscle) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BUN increase SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Creatinine increase SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Peripheral Edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View