Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan

Completed

• Conditions: Acromegaly
• Interventions: Drug: Somavert (Pegvisomant)

• Registration Number: NCT00658879
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2007-08-07
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-15
• Primary Completion: 2016-11-09
• Study Completion: 2016-11-09
• Results First Submitted: 2017-09-26
• Results First Submitted QC: 2018-08-09
• Results First Posted: 2019-01-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.

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Exclusion Criteria

Patients not administered Somavert (Pegvisomant).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somavert (Pegvisomant)	Somavert (Pegvisomant)	Patients taking Somavert (Pegvisomant).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)	5 years	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness.
Number of Participants With Treatment-Related Adverse Events by Age	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Number of Participants With Treatment-Related Adverse Events	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician.
Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Clinical Effectiveness Rate by Gender	5 years	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.
Clinical Effectiveness Rate by Age	5 years	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.
Number of Participants With Treatment-Related Adverse Events by Gender	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)	5 years	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Clinical Effectiveness Rate	5 years	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Clinical Effectiveness Rate in Participants With Hepatic Function Disorder	5 years	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness.