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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:55 PM
NCT ID: NCT03348956
Description: None
Frequency Threshold: 1
Time Frame: Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
Study: NCT03348956
Study Brief: Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EPR Oximetry All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. 0 None 0 7 6 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aches, Cramps and Spasms SYSTEMATIC_ASSESSMENT General disorders None View
Sore on tip of tongue SYSTEMATIC_ASSESSMENT General disorders None View
Tearing of eyes SYSTEMATIC_ASSESSMENT General disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT General disorders None View
Erythema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Increased symptoms of reflux SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Values SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High LFT's SYSTEMATIC_ASSESSMENT General disorders None View
Increased Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Soreness in both walls along MRM incision SYSTEMATIC_ASSESSMENT General disorders None View
CIPN SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Redness/Itchy on scalp SYSTEMATIC_ASSESSMENT General disorders None View
Cramping in calves- severe SYSTEMATIC_ASSESSMENT General disorders None View
Discomfort in anterior aspect of shins SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Dexterity SYSTEMATIC_ASSESSMENT General disorders None View
Increased unsteadiness SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Indigestion SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Sore Throat due to Nocturnal Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Alopecia SYSTEMATIC_ASSESSMENT General disorders None View
Anemia-Mild SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT General disorders None View
High WBC w/o infection SYSTEMATIC_ASSESSMENT General disorders None View
Thrush on tongue SYSTEMATIC_ASSESSMENT General disorders None View
Low K+ Lab SYSTEMATIC_ASSESSMENT General disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT General disorders None View
left ankle swelling-occasional SYSTEMATIC_ASSESSMENT General disorders None View
Pain during urination SYSTEMATIC_ASSESSMENT General disorders None View
Worsening Appetite SYSTEMATIC_ASSESSMENT General disorders None View
Knee Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain up to hip from knee SYSTEMATIC_ASSESSMENT General disorders None View
Shingles SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT General disorders None View
Bloating SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT General disorders None View
Brief periods of heart pounding SYSTEMATIC_ASSESSMENT General disorders None View
Brief burning sensation on chest, back, and legs SYSTEMATIC_ASSESSMENT General disorders None View
Low grade fever SYSTEMATIC_ASSESSMENT General disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT General disorders None View
Bilateral ankle swelling SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT General disorders None View
Cytopenia SYSTEMATIC_ASSESSMENT General disorders None View
Discomfort at Injection Site SYSTEMATIC_ASSESSMENT General disorders None View
Right Hip/Lower back pain SYSTEMATIC_ASSESSMENT General disorders None View
Myalgias SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Mild Cough SYSTEMATIC_ASSESSMENT General disorders None View
Mild Anemia SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgias SYSTEMATIC_ASSESSMENT General disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT General disorders None View
Acute Pharyngitis SYSTEMATIC_ASSESSMENT General disorders None View
Pain at injection site SYSTEMATIC_ASSESSMENT General disorders None View
Purple Hematoma at injection site SYSTEMATIC_ASSESSMENT General disorders None View
Rash-under Arm Pit SYSTEMATIC_ASSESSMENT General disorders None View
Redness along hands and wrists SYSTEMATIC_ASSESSMENT General disorders None View
Mouth Sore SYSTEMATIC_ASSESSMENT General disorders None View