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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT00538733
Description: None
Frequency Threshold: 4
Time Frame: Adverse events (serious and non-serious) were recorded from first dose of study drug, until removal from study (treatment).
Study: NCT00538733
Study Brief: Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed 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
T-BiRD Therapy (All Patients) All 26 patients that were enrolled onto the study were assessed for adverse events. 1 None 9 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dizziness/fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
rash (steven johnson syndrome) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
multiple compression fractures NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
renal insufficiency/Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
unspecified infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
anorexia/dysgeusia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dizziness SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
psychomotor agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
bacterial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
weakness SYSTEMATIC_ASSESSMENT General disorders None View