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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT00723294
Description: Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Frequency Threshold: 0
Time Frame: Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery.
Study: NCT00723294
Study Brief: Cryoablation Therapy in Treating Patients With Invasive Ductal 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
Treatment (Cryoablation) A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation. None None 0 90 48 90 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Intraoperative breast injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Nipple deformity SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View