Brief Title
Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
Official Title
Special Investigation Of Somavert -Long Term Use-
Brief Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed Description
All the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type
Observational
Primary Outcome
Number of Participants With Treatment-Related Adverse Events
Condition
Acromegaly
Intervention
Somavert (Pegvisomant)
Study Arms / Comparison Groups
Somavert (Pegvisomant)
Description: Patients taking Somavert (Pegvisomant).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
251
Start Date
August 7, 2007
Completion Date
November 9, 2016
Primary Completion Date
November 9, 2016
Eligibility Criteria
Inclusion Criteria: Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Somavert (Pegvisomant).
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Administrative Informations
NCT ID
NCT00658879
Organization ID
A6291023
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
August 2018