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 @ 9:25 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT00108732
Description: None
Frequency Threshold: 5
Time Frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Study: NCT00108732
Study Brief: A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for 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
Vaccinia/Fowlpox/GM-CSF Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity. Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months. None None 2 50 44 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever w/o neutropenia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever w/o neutropenia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain-other SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View