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 @ 6:59 PM
Ignite Modification Date: 2025-12-25 @ 4:32 PM
NCT ID: NCT02489357
Description: None
Frequency Threshold: 0
Time Frame: up to 2 years
Study: NCT02489357
Study Brief: Pembrolizumab and Cryosurgery in Treating Patients With Newly Diagnosed, Oligo-metastatic 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
Treatment (Pembrolizumab, Cryosurgery) Patients receive standard of care degarelix SC once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving pembrolizumab, patients undergo whole gland cryoablation of the prostate. Cryosurgery: Undergo whole gland cryoablation Degarelix: Given SC Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV 0 None 0 12 12 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile Dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Maculo-papular Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Penile pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Voice alteration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Skin induration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Groin Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Night sweats NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain, extremities NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View