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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT00561951
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00561951
Study Brief: Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subjects were treated with placebo once daily for 12 weeks. None None 5 318 68 318 View
Fesoterodine 4 mg Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. None None 3 320 138 320 View
Fesoterodine 8 mg Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. None None 0 313 185 313 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cervix carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Residual urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View