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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT02291432
Description: All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Frequency Threshold: 0
Time Frame: Adverse events were monitored from enrollment through study exit - 24 months total.
Study: NCT02291432
Study Brief: Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
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 Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs) 0 None 4 25 9 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 15.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 15.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post procedural contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 15.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 15.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 15.0 View
Post procedural swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 15.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 15.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.0 View
Laceration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View