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 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT04096820
Description: One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Frequency Threshold: 0
Time Frame: 15 months
Study: NCT04096820
Study Brief: Uromune in Treating Recurrent Urinary Tract Infections in Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing. 1 None 13 65 9 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Mastectomy NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Throidectomy NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Knee replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
rectal prolapse NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Accidental overdose of pain medication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper GI bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
radial bone fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
antibiotic related anaphylaxis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal events NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View