Adverse Events Module

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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 @ 3:49 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT01200992
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01200992
Study Brief: Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder 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
EN3348 8 mg mixed with sterile water for injection for a total volume of 50mL Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12) None None 4 37 32 37 View
Mitomycin C 40 mg mixed with sterile water for injection to a total volume of 40 mL Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12) None None 2 45 35 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Bladder spasms None Renal and urinary disorders None View
Bladder perforation None Renal and urinary disorders None View
Post-procedural hemorrhage None Injury, poisoning and procedural complications None View
Phlebitis None Vascular disorders None View
Sepsis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysuria None Renal and urinary disorders None View
Hematuria None Renal and urinary disorders None View
Pollakiuria None Renal and urinary disorders None View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Fatigue None General disorders None View
Urinary tract infection None Infections and infestations None View
Back pain None Musculoskeletal and connective tissue disorders None View