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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT02950259
Description: Adverse event monitoring/recording happened at set time intervals as per study protocol
Frequency Threshold: 0
Time Frame: 1 year, 3 months
Study: NCT02950259
Study Brief: Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IRX-2 Regimen -Early Stage Breast Cancer Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. 0 None 0 16 16 16 View
IRX-2 Regimen -Triple Negative Breast Cancer Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bruising/Bruising at Injection Site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu-like Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Intermittent Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Left Breast Pain SYSTEMATIC_ASSESSMENT General disorders None View
Mild Pain with Injections SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain with Injections SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Left Axillary Lymph Node Pain SYSTEMATIC_ASSESSMENT General disorders None View