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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT00939159
Description: None
Frequency Threshold: 5
Time Frame: Adverse event collected for eligible participants each three week treatment cycle. Overall study period: August 06, 2009 to March 17, 2011.
Study: NCT00939159
Study Brief: Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LBH589 LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle. None None 4 13 3 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
QTc Prolongation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Death/Disease Progression SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View