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: 2025-12-25 @ 1:03 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT03886493
Description: None
Frequency Threshold: 0
Time Frame: up to 1 year
Study: NCT03886493
Study Brief: Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate 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
Dupixent Subcutaneous (SQ) Injection Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. 0 None 0 7 7 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headache, intermittent NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
edema in right calf and ankle NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
elevated hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vivid dreams NON_SYSTEMATIC_ASSESSMENT General disorders None View
hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
induration at injection site on abdomen NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
laryngeal inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
loss of appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
maculo papular rash on abdomen NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pruritis at site of injection on abdomen NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
reproductive system disorder, other blood in ejaculate NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Right AC bruising related to blood draw NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration upper lip NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View