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

Status

Completed

Phase

Phase not stated

Enrollment

251 participants (actual)

Sponsor

Pfizer · Industry

Design

Not stated

Countries

Not stated

Start

7 Aug 2007

Primary completion

9 Nov 2016

Completion

9 Nov 2016

First posted

15 Apr 2008 (estimated)

Last update posted

25 Sept 2023

Conditions

Acromegaly

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.

• Other

  Somavert (Pegvisomant)

  Patients taking Somavert (Pegvisomant).

1. Number of Participants With Treatment-Related Adverse Events

   Time frame · 5 years

   Registry description

   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.

2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

   Time frame · 5 years

   Registry description

   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.

3. Number of Participants With Treatment-Related Adverse Events by Gender

   Time frame · 5 years

   Registry description

   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.

4. Number of Participants With Treatment-Related Adverse Events by Age

   Time frame · 5 years

   Registry description

   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.

5. Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder

   Time frame · 5 years

   Registry description

   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.

6. Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment

   Time frame · 5 years

   Registry description

   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.

7. Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)

   Time frame · 5 years

   Registry description

   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.

8. Clinical Effectiveness Rate

   Time frame · 5 years

   Registry description

   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.

9. Clinical Effectiveness Rate by Gender

   Time frame · 5 years

   Registry description

   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.

10. Clinical Effectiveness Rate by Age

    Time frame · 5 years

    Registry description

    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.

11. Clinical Effectiveness Rate in Participants With Hepatic Function Disorder

    Time frame · 5 years

    Registry description

    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.

12. Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)

    Time frame · 5 years

    Registry description

    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.

No study cites this trial.