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 @ 11:48 PM
Ignite Modification Date: 2025-12-25 @ 9:42 PM
NCT ID: NCT00446251
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00446251
Study Brief: Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab Infusion and Mycophenolate Mofetil Group Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated). None None 1 14 3 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infusion reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View