Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Special Investigation Of Somavert (Pegvisomant) - Long Term Use - (Regulatory Post Marketing Commitment Plan).|
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Factors considered to affect the safety and/or efficacy of this drug [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- The incidence of adverse drug reactions in this surveillance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes measures. [ Time Frame: There is no secondary outcomes for this surveillance. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients taking Pegvisomant.
Pegvisomant 10, 15 or 20mg powder and solvent for solution for injection.
Dosage, Frequency : According to Japanese LPD.
Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration.
All the patients whom an investigator prescribes the first Pegvisomant should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.