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: 2025-12-25 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT01382602
Description: Adverse events that occurred between initial blinded injection and unblinding of subjects after 12-month follow-up were compared between AMDC-USR and Placebo groups.
Frequency Threshold: 5
Time Frame: Adverse events were monitored from consent through study exit. Reporting groups are based on adverse events that occurred between initial blinded injection treatment and unblinding of subjects after 12-month follow-up.
Study: NCT01382602
Study Brief: Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AMDC-USR Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of AMDC-USR, at the 12 month follow-up. 0 None 0 93 32 93 View
Placebo Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of placebo, at the 12 month follow-up. 0 None 0 50 13 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (16.1) View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (16.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View