Adverse Events Module

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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 @ 2:34 PM
Ignite Modification Date: 2025-12-25 @ 1:06 PM
NCT ID: NCT02491359
Description: None
Frequency Threshold: 0
Time Frame: 30 days after stopping study drug
Study: NCT02491359
Study Brief: Carfilzomib in Treating Patients With Chronic Graft-Versus-Host Disease
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 (Carfilzomib) Patients receive carfilzomib IV over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. 2 None 8 20 7 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
fever/infusion reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
leg ulcers SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
acute renal failure/sepsis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
nausea/vomitting/diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
fungal lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
decreased lymphocyte count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
esophageal varices SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
increased ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Left hip hemiarthroplasty SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
rhinovirus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
intermittent hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View