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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:10 PM
NCT ID: NCT02369068
Description: The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
Frequency Threshold: 0
Time Frame: Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
Study: NCT02369068
Study Brief: Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Onabotulinumtoxin A Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations. An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series 0 None 0 10 5 10 View
Kenalog Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations. A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site). Kenalog: Intravaginal pelvic floor injection one series 0 None 0 11 4 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased Pelvic Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lower Extremity Numbness/Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exacerbation of Radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute Kidney Insufficiency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Facial Abrasions NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pericoronitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Yeast Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rib Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rectal Spasm NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal Incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View