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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
NCT ID: NCT00694551
Description: None
Frequency Threshold: 5
Time Frame: 2 years, 9 months
Study: NCT00694551
Study Brief: PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A. Peptide Vaccine Peptide vaccine dose Level 100 mcg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. None None 0 10 10 10 View
B. Peptide Vaccine Peptide vaccine dose level 300 mcg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. None None 1 10 10 10 View
C. Peptide Vaccine Peptide vaccine dose level 1 mg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. None None 0 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cough - Grade 2 - SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Feverr (in the absence of neutropenia) SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - Head/headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - Muscle SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - Back SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - Joint SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - Neck SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Injection site reaction/extravasation changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pulmonary/Upper Respiratory - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Flu-like syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Lymphatics - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Musculoskeletal/Soft Tissue - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Hot flashes/flushes SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View