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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:04 PM
NCT ID: NCT00847535
Description: During the study, 66 patients underwent a total of 78 biopsies, and 64 patients underwent intrasphincteric injection of AMDC.
Frequency Threshold: 5
Time Frame: Biopsy to treatment, 12 months Post-treatment
Study: NCT00847535
Study Brief: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women None None 8 66 18 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Biopsy to treatment: Drug hypersensitiviy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Biopsy to treatment: Femoral neck fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Post-treatment: Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Post-treatment: Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Post-treatment: Enterocolitis infectious SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Post-treatment: Intervertebral disc operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.0 View
Post-treatment: Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Post-treatment: Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Post-treatment: Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Biopsy to treatment: Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Post-treatment: Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Post-treatment: Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Post-treatment: Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Post-treatment: Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View