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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT00932035
Description: "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold: 0
Time Frame: Adverse events were collected over a period of 28 months.
Study: NCT00932035
Study Brief: Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With 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
Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies None None 1 18 13 18 View
Arm II (Control) Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies None None 1 21 15 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hearing impaired NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Localized edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Breast infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
JP Drain Blood Leak NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Glucose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chest wall pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Shoulder Joint Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain-post op NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast Swelling NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View