Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study (PACER)
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|ClinicalTrials.gov Identifier: NCT01946919|
Recruitment Status : Unknown
Verified November 2013 by Suodi ZHAI, Peking University Third Hospital.
Recruitment status was: Recruiting
First Posted : September 20, 2013
Last Update Posted : December 3, 2013
|Condition or disease|
|Adverse Drug Reaction Cinepazide Stroke|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||18000 participants|
|Target Follow-Up Duration:||14 Days|
|Official Title:||Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
Inpatient using the cinepazide in department of neurology
- Incidence of adverse drug reaction of cinepazide in department of neurology [ Time Frame: 1.5 years ]
- Outcomes of the patients who experienced an adverse drug reaction of cinepazide. [ Time Frame: 1.5 years ]Outcomes including cure, improved, null, or death.
- The predictors of the adverse drug reaction of cinepazide [ Time Frame: 1.5 years ]We will analyse whether some factors, such as age, gender, medical history and etc, would be the predictors of the adverse drug reaction of cinepazide.
- Types of the adverse drug reaction of cinepazide. [ Time Frame: 1.5 years ]The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.
- The treatment when patients experienced an adverse drug reaction of cinepazide. [ Time Frame: 1.5 years ]Treatments including oxygen, steroids, and etc. According to severity of the adverse drug reactions, we will analyse the features the treatments, such as types and numbers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946919
|Contact: Suodi ZHAI, BSfirstname.lastname@example.org|