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: 2025-12-25 @ 3:04 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT02833233
Description: None
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT02833233
Study Brief: A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage 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
Cryoablation and Immune Therapy Patients will undergo breast biopsy with cryoablation 7-10 days prior to the planned surgery, and ipilimumab with nivolumab administration 1-5 days before cryoablation. All patients will undergo surgery at the pre-determined day defined at the initial surgical consultation. Women will receive ipilimumab and nivolumab 1-5 days prior to US or MRI-guided core biopsy and cryoablation date. Intravenous ipilimumab will be administered as a single 1 mg/kg dose to be infused intravenously over 90 minutes. Intravenous nivolumab will be administered as a single 3 mg/kg dose to be infused intravenously over 60 minutes. 1 None 1 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View