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 @ 9:38 PM
Ignite Modification Date: 2025-12-25 @ 7:21 PM
NCT ID: NCT02463032
Description: None
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT02463032
Study Brief: Efficacy and Safety of GTx-024 in Patients With Estrogen Receptor (ER)+/Androgen Receptor (AR)+ Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GTx-024 9 mg Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate. 8 None 6 72 71 72 View
GTx-024 18 mg Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate. 8 None 10 64 56 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hypercalcemia SYSTEMATIC_ASSESSMENT Investigations None View
increased serum creatinine SYSTEMATIC_ASSESSMENT Investigations None View
acute kidney failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
anemia and marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
increased AST SYSTEMATIC_ASSESSMENT Investigations None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
h pylori infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
tumor flare SYSTEMATIC_ASSESSMENT Investigations None View
pyrexia SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
general disorder SYSTEMATIC_ASSESSMENT General disorders None View
investigations SYSTEMATIC_ASSESSMENT Investigations None View
metabolism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
nervous system SYSTEMATIC_ASSESSMENT Nervous system disorders None View
skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View