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 @ 6:32 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT01167257
Description: None
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT01167257
Study Brief: Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Arm Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation Liposome encapsulated botulinum toxin A' Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day None None 1 31 10 31 View
Control Arm Normal saline 50 mL in single intravesical instillation Normal saline instillation' Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation None None 2 31 16 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyponatremia SYSTEMATIC_ASSESSMENT General disorders None View
Right Knee osteoarthritis SYSTEMATIC_ASSESSMENT General disorders None View
C-spine whiplash injury with radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cervical spondylosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foreign body in conjunctival SAC SYSTEMATIC_ASSESSMENT Eye disorders None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unspecified otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Chronic mastoiditis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dizziness and giddiness SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal fullness pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory infection upper tract SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Couch SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unspecified local infections of skin and subcutaneous tissue SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fracture of ankle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Traumatic arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture of clavicle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Contusion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Functional disorder of stomach disturbance irritation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Herpes zoster SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Oral ulcer SYSTEMATIC_ASSESSMENT General disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT General disorders None View
Dermatophytosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View