Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:49 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT03200704
Description: The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Frequency Threshold: 1
Time Frame: Collected over the treatment duration period (Day 0) and followed through to Day 30
Study: NCT03200704
Study Brief: A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects 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
IC2000/SPY-PHI Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised. IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer 0 None 4 151 27 151 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Oxygen saturation decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Angina Pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Goitre NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site discoloration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Nausea NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin Flap Necrosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound Secretion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Oxygen Saturation Decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bone Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Wall Hematoma NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Device Occlusion NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ischemic Skin Ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Discoloration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Necrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View