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 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT00283803
Description: The term "adverse event" could include any of the following events that arise or increase in severity and/or frequency during the course of the study: * signs or symptoms * clinically significant laboratory abnormality * abnormality detected during physical exam These data will be recorded regardless of whether they are thought to be associated with the study or the drug under investigation.
Frequency Threshold: 5
Time Frame: Adverse Events collected for each patient from time of starting Exisulind through time of study withdraw, assessed up to 10 years.
Study: NCT00283803
Study Brief: Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate 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
Exisulind Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation. Exisulind: Exisulind 125 mg 0 None 1 32 21 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gallstone with cholecystectomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated LFTs SYSTEMATIC_ASSESSMENT Investigations None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hot Flashes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congested Sinuses/Cold NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia SYSTEMATIC_ASSESSMENT Investigations None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertriglyceridemia/Hyperlipidemia SYSTEMATIC_ASSESSMENT Investigations None View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain/Soreness/Cramps - leg(s) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased Libido NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View