Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT04907032
Description: Adverse events were collected on data sheets at each visit; medication (mirabegron or placebo to match) associated adverse effects such as 1) feeling sick (nausea), 2) constipation, 3) diarrhea, 4) urinary tract infection (UTI), 5) headaches, and 6) feeling dizzy, and for PTNS (posterior tibial nerve stimulation) which included 1) bleeding at the stimulation site, 2) lower extremity swelling, 3) worsening of urinary incontinence, 4) leg cramps, 5) vasovagal response, and 6) generalized headache.
Frequency Threshold: 2
Time Frame: During the study, each patient (all 54) were monitored for adverse events from baseline (start of the study) to 12 weeks (the end of the study for each patient.
Study: NCT04907032
Study Brief: Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M 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
Posterior Tibial Nerve Stimulation With Mirabegron One arm of the study will receive PTNS combined with mirabegron. In the PTNS with mirabegron arm, the patient will take a 50 mg dose daily for 12 weeks of the trial. This arm of the study will have 27 patients randomized to this arm of the study. The percutaneous approach entails insertion of a 36-gauge needle electrode at a 60 degree angle approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. A portable electrical stimulator delivers an adjustable current in the range of 0.5-9 mA. The generators commonly are set for a pulse frequency of 20 Hz with a goal of creating a motor and/or sensory response in the foot. The stimulation sessions last for 30 min once per week for 12 continuous weeks. Mirabegron 50 MG: Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo Posterior Tibial Nerve Stimulation (PTNS): Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo 0 None 0 27 6 27 View
Posterior Tibial Nerve Stimulation Plus Placebo The other arm of the study will receive PTNS with placebo. In the PTNS with placebo arm, the patient will receive a placebo daily during the 12-week trial. PTNS will be performed as described: The percutaneous approach entails insertion of a 36-gauge needle electrode at a 60 degree angle approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. A portable electrical stimulator delivers an adjustable current in the range of 0.5-9 mA. The generators commonly are set for a pulse frequency of 20 Hz with a goal of creating a motor and/or sensory response in the foot. The stimulation sessions last for 30 min once per week for 12 continuous weeks. Posterior Tibial Nerve Stimulation (PTNS): Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo 0 None 0 27 6 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT General disorders None View
transient leg swelling from PTNS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View