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: 2025-12-26 @ 12:14 PM
Ignite Modification Date: 2025-12-26 @ 12:14 PM
NCT ID: NCT03719300
Description: None
Frequency Threshold: 5
Time Frame: 9 months
Study: NCT03719300
Study Brief: Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm BC-819 The administration of BC-819 was separated into 2 phases, the induction phase, and the maintenance phase. During the induction phase, patients were to receive an intravesical instillation of BC-819 at a dose of 20 mg/50 mL aqueous solution once per week for 10 weeks according to the induction phase treatment schedule. Upon completion of the induction phase, patients transitioned to maintenance therapy of BC-819 every 3 weeks beginning at Week 12 (Visit 11) and continuing for the next 84 additional weeks until the end of the study, defined as completion of the 96-week visit (Visit 39). 0 None 3 32 23 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute left ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Micturition urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View