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: 2025-12-25 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:24 AM
NCT ID: NCT01371994
Description: None
Frequency Threshold: 5
Time Frame: From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Study: NCT01371994
Study Brief: A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
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 Participants received matching placebo tablets once a day for 12 weeks. None None 5 310 2 310 View
Solifenacin Succinate Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily. None None 7 313 19 313 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.0) View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (13.0) View
Arthritis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Infected Lymphocele SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Psoas Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Bladder Cancer Recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.0) View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (13.0) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Lymphocele SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View