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 @ 2:15 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT00667095
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00667095
Study Brief: Over Active Bladder Instillation Study - Botox
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Botox and DMSO Instillation Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided. None None 0 11 6 11 View
DMSO Instillation Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided. None None 2 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for body jerking and termons due to oligodendroglioma. SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization for joint pain due to infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization for tibial ulcer SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
High Blood Pressue SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Had fall, unable to walk SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bladder spasms after instillation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Swollen ankles SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nose Bleed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Left Distal Radius Fracture from a Twist and Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View