GPOS: Non Interventional Study For Patients Treated With Somavert®

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00858143
• Collaborator: (none)
• Enrollment: 311
• Duration (Months): 48

Study Details

Study Description

Brief Summary

This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Other: Non Interventional Observation

Detailed Description

Non probability samples

Study Design

• Study Type: Observational
• Actual Enrollment: 311 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: German Non Interventional Study For Patients Treated With Somavert®
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1	Other: Non Interventional Observation; Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

Outcome Measures

Primary Outcome Measures

1. Serious Adverse Events (SAE) and Adverse Events (AE) [Baseline up to 5 years]

   Long term safety of Somavert in treatment of patients with acromegaly

Secondary Outcome Measures

1. Change From Baseline Insulin-like Growth Factor I (IGF-I) [Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months]

   Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).

2. IGF-I Values Within Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

   Number of participants who have IGF-I values within normal range (local laboratory, different assay).

3. IGF-I Values Above Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

   Number of participants who have IGF-I values above normal range (local laboratory, different assay).

4. Change From Baseline Hemoglobin A 1c (HbA 1c) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

   Change: HbA 1c at observation minus HbA 1c at baseline.

5. HbA 1c Values Within Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

   Number of participants who have HbA 1c values within normal range.

6. HbA 1c Values Below Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)]

   Number of participants who have HbA 1c values below normal range.

7. HbA 1c Values Above Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

   Number of participants with HbA 1c values above normal range.

8. Change From Baseline Glucose (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

   Change: glucose at observation minus glucose at baseline.

9. Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)]

   Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.

10. Glucose Values Within Normal Range (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of participants who have glucose values within normal range (fasting).

11. Glucose Values Below Normal Range (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of participants with glucose values below normal range (fasting).

12. Glucose Values Above Normal Range (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of participants with glucose values above normal range (fasting).

13. Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of participants with glucose values (2h oGTT) within normal range.

14. Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of participants with glucose values (2h oGTT) above normal range.

15. IGF-I Absolute Values [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    IGF-I absolute values (local laboratory, different assay).

16. Absolute Glucose Values (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Absolute Glucose values (fasting)

17. Absolute Glucose Values (2h oGTT) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).

18. Absolute Hemoglobin A 1c (HbA 1c) Values [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Absolute value Hemoglobin A 1c (HbA 1c)

19. Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).

20. Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).

21. Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).

22. Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).

23. Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes

24. Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Change: HbA 1c at observation minus HbA 1c at baseline.

25. HbA 1c Values Within Normal Range in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients with HbA 1c Values Within Normal Range.

26. HbA 1c Values Below Normal Range in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients with HbA 1c Values Below Normal Range

27. HbA 1c Values Above Normal Range in Diabetic Patients [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients with HbA 1c Values Above Normal Range

28. Glucose Change From Baseline in Diabetic Patients (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Change: glucose at observation minus glucose at baseline

29. Absolute Glucose Values in Diabetic Patients (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Absolute Glucose Values in Patients with Diabetes (fasting)

30. Glucose Values Within Normal Range in Diabetic Patients (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range

31. Glucose Values Above Normal Range in Diabetic Patients (Fasting) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range

32. Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

33. Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

34. Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

35. Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

36. Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

37. Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

38. Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).

39. Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)]

    Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.

40. Mean Change From Baseline for Body Weight [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)]

    Change: body weight at observation minus body weight at baseline

41. Change From Baseline for Diastolic Blood Pressure (BP) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)]

    Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline

42. Change From Baseline for Systolic Blood Pressure (BP) [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)]

    Change: systolic blood pressure at observation minus systolic blood pressure at baseline

43. Change From Baseline in Ring Size [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Change from baseline: ring size at observation minus ring size at baseline

44. Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.

45. Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population [Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)]

    Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.

Exclusion Criteria:

• Subjects treated with an investigational drug for treatment of acromegaly.

• Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery.

• Women who were pregnant or lactating.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00858143
• Other Study ID Numbers: A6291014
• First Posted: Mar 9, 2009
• Last Update Posted: Sep 2, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
• Additional relevant MeSH terms: Acromegaly

Study Results

Participant Flow

Pre-assignment Detail	Somavert® (active ingredient: Pegvisomant 10/15/20 mg). Dose and schedule were at discretion of each treating physician. Safety evaluations based on all 311 patients who received at least one dose of Somavert® (safety set). Results from 270 patients in the intent-to-treat (ITT) population were analyzed to evaluate the efficacy of Somavert® therapy.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Period Title: Overall Study
STARTED	311
COMPLETED	261
NOT COMPLETED	50

Baseline Characteristics

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Overall Participants	311
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (13.8)
Sex: Female, Male (Count of Participants)
Female	154 49.5%
Male	157 50.5%

Outcome Measures

1. Secondary Outcome

Title	Change From Baseline Insulin-like Growth Factor I (IGF-I)
Description	Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
Time Frame	Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=243)	-200.3 (239.1)
Follow-up 2 (n=202)	-202.6 (327.7)
Follow-up 3 (n=131)	-273.7 (251.3)
Follow-up 4 (n=71)	-319.6 (234.7)
Follow-up 5 (n=18)	-296.6 (189.6)

2. Secondary Outcome

Title	IGF-I Values Within Normal Range
Description	Number of participants who have IGF-I values within normal range (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=266)	59
Follow-up 1 (n=261)	156
Follow-up 2 (n=222)	154
Follow-up 3 (n=147)	108
Follow-up 4 (n=79)	56
Follow-up 5 (n=21)	14

3. Secondary Outcome

Title	IGF-I Values Above Normal Range
Description	Number of participants who have IGF-I values above normal range (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=266)	207
Follow-up 1 (n=261)	105
Follow-up 2 (n=222)	68
Follow-up 3 (n=147)	39
Follow-up 4 (n=79)	23
Follow-up 5 (n=21)	7

4. Secondary Outcome

Title	Change From Baseline Hemoglobin A 1c (HbA 1c)
Description	Change: HbA 1c at observation minus HbA 1c at baseline.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=124)	-0.3 (0.9)
Follow-up 2 (n=123)	-0.3 (1.0)
Follow-up 3 (n=80)	-0.3 (1.1)
Follow-up 4 (n=41)	-0.3 (1.6)
Follow-up 5 (n=10)	-0.0 (0.7)

5. Secondary Outcome

Title	HbA 1c Values Within Normal Range
Description	Number of participants who have HbA 1c values within normal range.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=173)	104
Follow-up 1 (n=132)	85
Follow-up 2 (n=127)	78
Follow-up 3 (n=82)	57
Follow-up 4 (n=43)	30
Follow-up 5 (n=10)	7

6. Secondary Outcome

Title	HbA 1c Values Below Normal Range
Description	Number of participants who have HbA 1c values below normal range.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=173)	0 0%
Follow-up 1 (n=132)	1 0.3%
Follow-up 2 (n=127)	1 0.3%
Follow-up 3 (n=82)	1 0.3%
Follow-up 4 (n=43)	0 0%
Follow-up 5 (n=10)	0 0%

7. Secondary Outcome

Title	HbA 1c Values Above Normal Range
Description	Number of participants with HbA 1c values above normal range.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=173)	69 22.2%
Follow-up 1 (n=132)	46 14.8%
Follow-up 2 (n=127)	48 15.4%
Follow-up 3 (n=82)	24 7.7%
Follow-up 4 (n=43)	13 4.2%
Follow-up 5 (n=10)	3 1%

8. Secondary Outcome

Title	Change From Baseline Glucose (Fasting)
Description	Change: glucose at observation minus glucose at baseline.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=121)	-11.6 (39.6)
Follow-up 2 (n=103)	-14.2 (40.1)
Follow-up 3 (n=70)	-19.7 (45.7)
Follow-up 4 (n=33)	-12.9 (51.0)
Follow-up 5 (n=8)	-10.5 (18.3)

9. Secondary Outcome

Title	Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Description	Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=3)	-1.5 (38.7)
Follow-up 2 (n=2)	-56.8 (85.4)
Follow-up 3 (n=2)	-61.3 (79.0)

10. Secondary Outcome

Title	Glucose Values Within Normal Range (Fasting)
Description	Number of participants who have glucose values within normal range (fasting).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=172)	116 37.3%
Follow-up 1 (n=132)	103 33.1%
Follow-up 2 (n=117)	93 29.9%
Follow-up 3 (n=78)	65 20.9%
Follow-up 4 (n=35)	25 8%
Follow-up 5 (n=8)	6 1.9%

11. Secondary Outcome

Title	Glucose Values Below Normal Range (Fasting)
Description	Number of participants with glucose values below normal range (fasting).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=172)	2 0.6%
Follow-up 1 (n=132)	3 1%
Follow-up 2 (n=117)	1 0.3%
Follow-up 3 (n=78)	1 0.3%
Follow-up 4 (n=35)	0 0%
Follow-up 5 (n=8)	0 0%

12. Secondary Outcome

Title	Glucose Values Above Normal Range (Fasting)
Description	Number of participants with glucose values above normal range (fasting).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=172)	54 17.4%
Follow-up 1 (n=132)	26 8.4%
Follow-up 2 (n=117)	23 7.4%
Follow-up 3 (n=78)	12 3.9%
Follow-up 4 (n=35)	10 3.2%
Follow-up 5 (n=8)	2 0.6%

13. Secondary Outcome

Title	Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Description	Number of participants with glucose values (2h oGTT) within normal range.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=7)	5 1.6%
Follow-up 1 (n=4)	3 1%
Follow-up 2 (n=3)	3 1%
Follow-up 3 (n=3)	3 1%
Follow-up 4 (n=0)	0 0%
Follow-up 5 (n=0)	0 0%

14. Secondary Outcome

Title	Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Description	Number of participants with glucose values (2h oGTT) above normal range.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=7)	2 0.6%
Follow-up 1 (n=4)	1 0.3%
Follow-up 2 (n=3)	0 0%
Follow-up 3 (n=3)	0 0%
Follow-up 4 (n=0)	0 0%
Follow-up 5 (n=0)	0 0%

15. Secondary Outcome

Title	IGF-I Absolute Values
Description	IGF-I absolute values (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=252)	480.1 (249.5)
Follow-up 1 (n=243)	277.2 (160.5)
Follow-up 2 (n=202)	281.6 (285.0)
Follow-up 3 (n=131)	240.6 (134.7)
Follow-up 4 (n=71)	236.1 (124.2)
Follow-up 5 (n=18)	241.8 (107.4)

16. Secondary Outcome

Title	Absolute Glucose Values (Fasting)
Description	Absolute Glucose values (fasting)
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=158)	112.6 (44.3)
Follow-up 1 (n=121)	104.5 (42.6)
Follow-up 2 (n=103)	98.7 (34.0)
Follow-up 3 (n=70)	95.2 (17.6)
Follow-up 4 (n=33)	105.9 (42.7)
Follow-up 5 (n=8)	107.5 (31.1)

17. Secondary Outcome

Title	Absolute Glucose Values (2h oGTT)
Description	Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=5)	130.6 (60.2)
Follow-up 1 (n=3)	145.3 (71.8)
Follow-up 2 (n=2)	108.1 (10.2)
Follow-up 3 (n=2)	112.6 (3.8)

18. Secondary Outcome

Title	Absolute Hemoglobin A 1c (HbA 1c) Values
Description	Absolute value Hemoglobin A 1c (HbA 1c)
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Baseline (n=166)	6.2 (1.2)
Follow-up 1 (n=124)	6.0 (1.1)
Follow-up 2 (n=123)	6.1 (1.1)
Follow-up 3 (n=80)	6.0 (1.1)
Follow-up 4 (n=41)	6.1 (1.1)
Follow-up 5 (n=10)	6.1 (0.9)

19. Secondary Outcome

Title	Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Description	Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Follow-up 1 (n=75)	-207.5
Follow-up 2 (n=67)	-194.5
Follow-up 3 (n=44)	-274.6
Follow-up 4 (n=24)	-314.9
Follow-up 5 (n=4)	-90.5

20. Secondary Outcome

Title	Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Description	Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=78)	478.8 (264.6)
Follow-up 1 (n=75)	276.4 (145.9)
Follow-up 2 (n=67)	293.2 (212.3)
Follow-up 3 (n=44)	239.3 (142.6)
Follow-up 4 (n=24)	242.5 (115.5)
Follow-up 5 (n=4)	311.3 (203.9)

21. Secondary Outcome

Title	Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Description	Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=81)	14 4.5%
Follow-up 1 (n=80)	41 13.2%
Follow-up 2 (n=74)	47 15.1%
Follow-up 3 (n=49)	35 11.3%
Follow-up 4 (n=26)	16 5.1%
Follow-up 5 (n=5)	3 1%

22. Secondary Outcome

Title	Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Description	Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=81)	67 21.5%
Follow-up 1 (n=80)	39 12.5%
Follow-up 2 (n=74)	27 8.7%
Follow-up 3 (n=49)	14 4.5%
Follow-up 4 (n=26)	10 3.2%
Follow-up 5 (n=5)	2 0.6%

23. Secondary Outcome

Title	Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Description	Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=67)	7.0 (1.4)
Follow-up 1 (n=58)	6.6 (1.2)
Follow-up 2 (n=60)	6.5 (1.2)
Follow-up 3 (n=36)	6.6 (1.3)
Follow-up 4 (n=21)	6.6 (1.3)
Follow-up 5 (n=5)	6.6 (1.0)

24. Secondary Outcome

Title	Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Description	Change: HbA 1c at observation minus HbA 1c at baseline.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Follow-up 1 (n=58)	-0.4
Follow-up 2 (n=60)	-0.5
Follow-up 3 (n=36)	-0.5
Follow-up 4 (n=21)	-0.6
Follow-up 5 (n=5)	-0.2

25. Secondary Outcome

Title	HbA 1c Values Within Normal Range in Diabetic Patients
Description	Number of Diabetic Patients with HbA 1c Values Within Normal Range.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=72)	24 7.7%
Follow-up 1 (n=64)	25 8%
Follow-up 2 (n=62)	24 7.7%
Follow-up 3 (n=38)	17 5.5%
Follow-up 4 (n=22)	10 3.2%
Follow-up 5 (n=5)	3 1%

26. Secondary Outcome

Title	HbA 1c Values Below Normal Range in Diabetic Patients
Description	Number of Diabetic Patients with HbA 1c Values Below Normal Range
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=72)	0
Follow-up 1 (n=64)	1
Follow-up 2 (n=62)	1
Follow-up 3 (n=38)	0
Follow-up 4 (n=22)	0
Follow-up 5 (n=5)	0

27. Secondary Outcome

Title	HbA 1c Values Above Normal Range in Diabetic Patients
Description	Number of Diabetic Patients with HbA 1c Values Above Normal Range
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=72)	48
Follow-up 1 (n=64)	38
Follow-up 2 (n=62)	37
Follow-up 3 (n=38)	21
Follow-up 4 (n=22)	12
Follow-up 5 (n=5)	2

28. Secondary Outcome

Title	Glucose Change From Baseline in Diabetic Patients (Fasting)
Description	Change: glucose at observation minus glucose at baseline
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Follow-up 1 (n=42)	-17.2
Follow-up 2 (n=37)	-24.9
Follow-up 3 (n=21)	-50.7
Follow-up 4 (n=13)	-14.8
Follow-up 5 (n=3)	-17.7

29. Secondary Outcome

Title	Absolute Glucose Values in Diabetic Patients (Fasting)
Description	Absolute Glucose Values in Patients with Diabetes (fasting)
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=51)	142.1 (62.3)
Follow-up 1 (n=42)	131.0 (59.4)
Follow-up 2 (n=37)	112.9 (49.7)
Follow-up 3 (n=21)	101.9 (21.7)
Follow-up 4 (n=13)	130.6 (58.9)
Follow-up 5 (n=3)	120.7 (52.3)

30. Secondary Outcome

Title	Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Description	Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n= 57)	24 7.7%
Follow-up 1 (n=47)	28 9%
Follow-up 2 (n=42)	25 8%
Follow-up 3 (n=25)	18 5.8%
Follow-up 4 (n=14)	6 1.9%
Follow-up 5 (n=3)	2 0.6%

31. Secondary Outcome

Title	Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Description	Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	192
Baseline (n=57)	33 10.6%
Follow-up 1 (n=47)	19 6.1%
Follow-up 2 (n=42)	17 5.5%
Follow-up 3 (n=25)	7 2.3%
Follow-up 4 (n=14)	8 2.6%
Follow-up 5 (n=3)	1 0.3%

32. Secondary Outcome

Title	Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=107)	-0.3
Follow-up 2 (n=89)	-0.4
Follow-up 3 (n=60)	-0.2
Follow-up 4 (n=14)	-0.7

33. Secondary Outcome

Title	Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=108)	-0.1
Follow-up 2 (n=89)	-0.4
Follow-up 3 (n=60)	-0.0
Follow-up 4 (n=14)	-0.8

34. Secondary Outcome

Title	Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=108)	-0.6
Follow-up 2 (n=89)	-0.2
Follow-up 3 (n=60)	0.0
Follow-up 4 (n=14)	0.6

35. Secondary Outcome

Title	Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=106)	0.2
Follow-up 2 (n=88)	-0.5
Follow-up 3 (n=59)	-0.4
Follow-up 4 (n=14)	-0.4

36. Secondary Outcome

Title	Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=105)	-0.6
Follow-up 2 (n=88)	-0.8
Follow-up 3 (n=60)	-0.8
Follow-up 4 (n=14)	-1.2

37. Secondary Outcome

Title	Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=108)	-0.7
Follow-up 2 (n=89)	-0.6
Follow-up 3 (n=60)	-0.6
Follow-up 4 (n=14)	-0.8

38. Secondary Outcome

Title	Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=106)	-0.6
Follow-up 2 (n=89)	-0.6
Follow-up 3 (n=59)	-0.6
Follow-up 4 (n=14)	-0.5

39. Secondary Outcome

Title	Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Description	Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)

Outcome Measure Data

Analysis Population Description

ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	131
Follow-up 1 (n=107)	-2.3
Follow-up 2 (n=89)	-2.7
Follow-up 3 (n=60)	-2.0
Follow-up 4 (n=14)	-3.5

40. Secondary Outcome

Title	Mean Change From Baseline for Body Weight
Description	Change: body weight at observation minus body weight at baseline
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=213)	0.0 (5.2)
Follow-up 2 (n=185)	0.6 (6.0)
Follow-up 3 (n=118)	2.1 (7.4)
Follow-up 4 (n=61)	1.6 (7.7)
Follow-up 5 (n=13)	3.0 (8.4)

41. Secondary Outcome

Title	Change From Baseline for Diastolic Blood Pressure (BP)
Description	Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=217)	-1.0 (11.0)
Follow-up 2 (n=189)	-1.2 (13.0)
Follow-up 3 (n=124)	-1.5 (13.4)
Follow-up 4 (n=64)	1.8 (15.2)
Follow-up 5 (n=15)	2.5 (15.1)

42. Secondary Outcome

Title	Change From Baseline for Systolic Blood Pressure (BP)
Description	Change: systolic blood pressure at observation minus systolic blood pressure at baseline
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=217)	-0.1 (17.2)
Follow-up 2 (n=189)	-2.9 (18.1)
Follow-up 3 (n=124)	-4.3 (19.2)
Follow-up 4 (n=65)	2.1 (21.4)
Follow-up 5 (n=15)	8.4 (15.4)

43. Secondary Outcome

Title	Change From Baseline in Ring Size
Description	Change from baseline: ring size at observation minus ring size at baseline
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Follow-up 1 (n=99)	0.2 (4.7)
Follow-up 2 (n=82)	-0.8 (8.3)
Follow-up 3 (n=37)	-0.3 (11.8)
Follow-up 4 (n=16)	-6.1 (15.7)
Follow-up 5 (n=2)	0.0 (0.0)

44. Secondary Outcome

Title	Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
Description	Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	305
Number [milligram (mg)]	16.8

45. Primary Outcome

Title	Serious Adverse Events (SAE) and Adverse Events (AE)
Description	Long term safety of Somavert in treatment of patients with acromegaly
Time Frame	Baseline up to 5 years

Outcome Measure Data

Analysis Population Description

Safety Population; all patients who received at least one dose of Somavert® during the observation period.

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	311
Serious Adverse Events (SAE's)	116 37.3%
Adverse Events (AE's)	197 63.3%

46. Secondary Outcome

Title	Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
Description	Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.
Time Frame	Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129).

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
Measure Participants	270
Number [milligram (mg)]	16.4

Adverse Events

Arm/Group Title	Somavert®
Arm/Group Description	Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
All Cause Mortality
	Somavert®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Somavert®
	Affected / at Risk (%)	# Events
Total	116/ (NaN)
Blood and lymphatic system disorders
Anaemia	1/311 (0.3%)
Cardiac disorders
Aortic valve incompetence	2/311 (0.6%)
Tachyarrhythmia	2/311 (0.6%)
Acute myocardial infarction	1/311 (0.3%)
Angina pectoris	1/311 (0.3%)
Aortic valve sclerosis	1/311 (0.3%)
Atrial fibrillation	1/311 (0.3%)
Cardiac failure	1/311 (0.3%)
Coronary artery disease	1/311 (0.3%)
Cyanosis	1/311 (0.3%)
Myocardial infarction	1/311 (0.3%)
Ventricular fibrillation	1/311 (0.3%)
Ventricular tachycardia	1/311 (0.3%)
Congenital, familial and genetic disorders
Adenomatous polyposis coli	1/311 (0.3%)
Endocrine disorders
Adrenocortical insufficiency acute	2/311 (0.6%)
Toxic nodular goitre	2/311 (0.6%)
Hypopituitarism	1/311 (0.3%)
Eye disorders
Blindness transient	1/311 (0.3%)
Optic ischaemic neuropathy	1/311 (0.3%)
Gastrointestinal disorders
Pancreatitis	3/311 (1%)
Colitis	1/311 (0.3%)
Colonic polyp	1/311 (0.3%)
Diverticular perforation	1/311 (0.3%)
Gastritis haemorrhagic	1/311 (0.3%)
Ileus	1/311 (0.3%)
Pancreatitis acute	1/311 (0.3%)
Umbilical hernia	1/311 (0.3%)
General disorders
Cardiac death	2/311 (0.6%)
Application site necrosis	1/311 (0.3%)
Condition aggravated	1/311 (0.3%)
Disease progression	1/311 (0.3%)
No adverse event	1/311 (0.3%)
Pain	1/311 (0.3%)
Hepatobiliary disorders
Cholelithiasis	9/311 (2.9%)
Bile duct stone	2/311 (0.6%)
Biliary colic	2/311 (0.6%)
Cholangitis	2/311 (0.6%)
Hepatocellular injury	2/311 (0.6%)
Cholecystitis	1/311 (0.3%)
Cholecystitis acute	1/311 (0.3%)
Infections and infestations
Infection	2/311 (0.6%)
Pneumonia	2/311 (0.6%)
Injury, poisoning and procedural complications
Femur fracture	2/311 (0.6%)
Joint dislocation	2/311 (0.6%)
Lower limb fracture	2/311 (0.6%)
Road traffic accident	2/311 (0.6%)
Drug exposure during pregnancy	1/311 (0.3%)
Fall	1/311 (0.3%)
Hand fracture	1/311 (0.3%)
Rib fracture	1/311 (0.3%)
Whiplash injury	1/311 (0.3%)
Investigations
Hepatic enzyme increased	13/311 (4.2%)
Transaminases increased	7/311 (2.3%)
Insulin-like growth factor increased	2/311 (0.6%)
Alanine aminotransferase increased	1/311 (0.3%)
blood creatine phosphokinase increased	1/311 (0.3%)
Colonoscopy	1/311 (0.3%)
Gamma-glutamyltransferase increased	1/311 (0.3%)
Metabolism and nutrition disorders
Diabetes mellitus	1/311 (0.3%)
Diabetic foot	1/311 (0.3%)
Electrolyte imbalance	1/311 (0.3%)
Musculoskeletal and connective tissue disorders
Back pain	1/311 (0.3%)
Cervical spinal stenosis	1/311 (0.3%)
Muscle spasms	1/311 (0.3%)
Myalgia	1/311 (0.3%)
Spinal disorder	1/311 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign	16/311 (5.1%)
Pituitary tumour	7/311 (2.3%)
Neoplasm progression	5/311 (1.6%)
Colon cancer	2/311 (0.6%)
Pituitary tumour recurrent	2/311 (0.6%)
Breast cancer female	1/311 (0.3%)
Bronchioloalveolar carcinoma	1/311 (0.3%)
Cholesteatoma	1/311 (0.3%)
Extragonadal primary malignant teratoma	1/311 (0.3%)
Gastric cancer	1/311 (0.3%)
Glioblastoma	1/311 (0.3%)
Lung squamous cell carcinoma stage unspecified	1/311 (0.3%)
Meningioma	1/311 (0.3%)
Metastases to abdominal wall	1/311 (0.3%)
Prostate cancer	1/311 (0.3%)
Recurrent cancer	1/311 (0.3%)
Renal cancer	1/311 (0.3%)
Renal cell carcinoma	1/311 (0.3%)
Respiratory tract neoplasm	1/311 (0.3%)
Transitional cell carcinoma	1/311 (0.3%)
Ureteral neoplasm	1/311 (0.3%)
Uterine leiomyoma	1/311 (0.3%)
Nervous system disorders
Epilepsy	3/311 (1%)
Anosmia	1/311 (0.3%)
Cerebrospinal fistula	1/311 (0.3%)
Cerebrospinal fluid rhinorrhoea	1/311 (0.3%)
Chiasma syndrome	1/311 (0.3%)
Hypoaesthesia	1/311 (0.3%)
Hyposmia	1/311 (0.3%)
Reversible ischaemic neurological deficit	1/311 (0.3%)
Transient ischaemic attack	1/311 (0.3%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	1/311 (0.3%)
Pregnancy	1/311 (0.3%)
Renal and urinary disorders
Hydronephrosis	1/311 (0.3%)
Reproductive system and breast disorders
Menorrhagia	1/311 (0.3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/311 (0.6%)
Dyspnoea	2/311 (0.6%)
Pulmonary embolism	2/311 (0.6%)
Dysphonia	1/311 (0.3%)
Surgical and medical procedures
Cholecystectomy	8/311 (2.6%)
Pituitary tumour removal	8/311 (2.6%)
Appendicectomy	1/311 (0.3%)
Cardiac pacemaker insertion	1/311 (0.3%)
Gallbladder operation	1/311 (0.3%)
Gastrectomy	1/311 (0.3%)
Hysterectomy	1/311 (0.3%)
Knee arthroplasty	1/311 (0.3%)
Knee operation	1/311 (0.3%)
Laparoscopic surgery	1/311 (0.3%)
Nephrectomy	1/311 (0.3%)
Pituitary gland radiotherapy	1/311 (0.3%)
Radiotherapy	1/311 (0.3%)
Radiotherapy to brain	1/311 (0.3%)
Umbilical hernia repair	1/311 (0.3%)
Vascular disorders
Deep vein thrombosis	3/311 (1%)
Hypertension	2/311 (0.6%)
Hypertensive crisis	1/311 (0.3%)
Peripheral circulatory failure	1/311 (0.3%)
Other (Not Including Serious) Adverse Events
	Somavert®
	Affected / at Risk (%)	# Events
Total	197/ (NaN)
Blood and lymphatic system disorders
Anaemia	2/311 (0.6%)
Iron deficiency anaemia	1/311 (0.3%)
Cardiac disorders
Aortic valve incompetence	2/311 (0.6%)
Atrial fibrillation	2/311 (0.6%)
Cardiac failure	2/311 (0.6%)
Tachyarrhythmia	2/311 (0.6%)
Acute myocardial infarction	1/311 (0.3%)
Angina pectoris	1/311 (0.3%)
Aortic valve sclerosis	1/311 (0.3%)
Arrhythmia	1/311 (0.3%)
Coronary artery disease	1/311 (0.3%)
Cyanosis	1/311 (0.3%)
Myocardial infarction	1/311 (0.3%)
Sinus arrhythmia	1/311 (0.3%)
Ventricular fibrillation	1/311 (0.3%)
Ventricular tachycardia	1/311 (0.3%)
Congenital, familial and genetic disorders
Adenomatous polyposis coli	3/311 (1%)
Ear and labyrinth disorders
Hypoacusis	1/311 (0.3%)
Endocrine disorders
Adrenal insufficiency	3/311 (1%)
Hypopituitarism	3/311 (1%)
Adrenocortical insufficiency acute	2/311 (0.6%)
Gonadotrophin deficiency	2/311 (0.6%)
Hypogonadism	2/311 (0.6%)
Toxic nodular goitre	2/311 (0.6%)
Diabetes insipidus	1/311 (0.3%)
Hyperparathyroidism primary	1/311 (0.3%)
Hyperprolactinaemia	1/311 (0.3%)
Hyperthyroidism	1/311 (0.3%)
Pituitary haemorrhage	1/311 (0.3%)
Secondary hypothyroidism	1/311 (0.3%)
Eye disorders
Visual acuity reduced	2/311 (0.6%)
Blindness transient	1/311 (0.3%)
Cataract	1/311 (0.3%)
Glaucoma	1/311 (0.3%)
Optic ischaemic neuropathy	1/311 (0.3%)
Gastrointestinal disorders
Constipation	6/311 (1.9%)
Pancreatitis	3/311 (1%)
Diarrhoea	2/311 (0.6%)
Gastrooesophageal reflux disease	2/311 (0.6%)
Abdominal pain lower	1/311 (0.3%)
Abdominal pain upper	1/311 (0.3%)
Colitis	1/311 (0.3%)
Colonic polyp	1/311 (0.3%)
Diverticular perforation	1/311 (0.3%)
Dyspepsia	1/311 (0.3%)
Faecal incontinence	1/311 (0.3%)
Gastric cyst	1/311 (0.3%)
Gastritis	1/311 (0.3%)
Gastritis erosive	1/311 (0.3%)
Gastritis haemorrhagic	1/311 (0.3%)
Gastrointestinal pain	1/311 (0.3%)
Gingivitis	1/311 (0.3%)
Haemorrhoids	1/311 (0.3%)
Ileus	1/311 (0.3%)
Nausea	1/311 (0.3%)
Pancreatitis acute	1/311 (0.3%)
Reflux oesophagitis	1/311 (0.3%)
Stomach discomfort	1/311 (0.3%)
Umbilical hernia	1/311 (0.3%)
General disorders
Fat tissue increased	5/311 (1.6%)
Injection site erythema	5/311 (1.6%)
Disease progression	4/311 (1.3%)
Cardiac death	2/311 (0.6%)
Fatigue	2/311 (0.6%)
Injection site hypertrophy	2/311 (0.6%)
Injection site reaction	2/311 (0.6%)
Injection site swelling	2/311 (0.6%)
Pain	2/311 (0.6%)
Adverse drug reaction	1/311 (0.3%)
Application site necrosis	1/311 (0.3%)
Condition aggravated	1/311 (0.3%)
Drug ineffective	1/311 (0.3%)
Facial pain	1/311 (0.3%)
Feeling cold	1/311 (0.3%)
Influenza like illness	1/311 (0.3%)
Injection site induration	1/311 (0.3%)
Injection site oedema	1/311 (0.3%)
Injection site pruritus	1/311 (0.3%)
No adverse event	1/311 (0.3%)
Ulcer	1/311 (0.3%)
Hepatobiliary disorders
Cholelithiasis	13/311 (4.2%)
Biliary colic	3/311 (1%)
Bile duct stone	2/311 (0.6%)
Cholangitis	2/311 (0.6%)
Hepatocellular injury	2/311 (0.6%)
Cholecystitis	1/311 (0.3%)
Cholecystitis acute	1/311 (0.3%)
Hepatic cyst	1/311 (0.3%)
Immune system disorders
House dust allergy	1/311 (0.3%)
Infections and infestations
Pneumonia	3/311 (1%)
Sinusitis	2/311 (0.6%)
Dermatophytosis	1/311 (0.3%)
Helicobacter gastritis	1/311 (0.3%)
Helicobacter infection	1/311 (0.3%)
Herpes Zoster	1/311 (0.3%)
Lobar pneumonia	1/311 (0.3%)
Urinary tract infection	1/311 (0.3%)
Viral infection	1/311 (0.3%)
Injury, poisoning and procedural complications
Femur fracture	2/311 (0.6%)
Joint dislocation	2/311 (0.6%)
Lower limb fracture	2/311 (0.6%)
Road traffic accident	2/311 (0.6%)
Drug exposure during pregnancy	1/311 (0.3%)
Fall	1/311 (0.3%)
Hand fracture	1/311 (0.3%)
Procedural headache	1/311 (0.3%)
Radiation associated pain	1/311 (0.3%)
Rib fracture	1/311 (0.3%)
Whiplash injury	1/311 (0.3%)
Hyperhidrosis	1/311 (0.3%)
Investigations
Hepatic enzyme increased	21/311 (6.8%)
Transaminases increased	11/311 (3.5%)
Alanine aminotransferase increased	4/311 (1.3%)
Insulin-like growth factor increased	3/311 (1%)
Aspartate aminotransferase increased	2/311 (0.6%)
Gamma-glutamyltransferase increased	2/311 (0.6%)
Weight increased	2/311 (0.6%)
Analgesic drug level increased	1/311 (0.3%)
Blood creatine phosphokinase increased	1/311 (0.3%)
Blood pressure increased	1/311 (0.3%)
Colonoscopy	1/311 (0.3%)
Waist circumference increased	1/311 (0.3%)
Metabolism and nutrition disorders
Diabetes mellitus	3/311 (1%)
Vitamin D deficiency	3/311 (1%)
Hypercholesterolaemia	2/311 (0.6%)
Hyperlipidaemia	2/311 (0.6%)
Iron deficiency	2/311 (0.6%)
Diabetic foot	1/311 (0.3%)
Electrolyte imbalance	1/311 (0.3%)
Hyperuricaemia	1/311 (0.3%)
Hypoglycaemia	1/311 (0.3%)
Hypokalaemia	1/311 (0.3%)
Lactose intolerance	1/311 (0.3%)
Infection	2/311 (0.6%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	3/311 (1%)
Back pain	2/311 (0.6%)
Muscle spasms	2/311 (0.6%)
Myalgia	2/311 (0.6%)
Arthralgia	1/311 (0.3%)
Bone pain	1/311 (0.3%)
Cervical spinal stenosis	1/311 (0.3%)
Chondropathy	1/311 (0.3%)
Musculoskeletal pain	1/311 (0.3%)
Nodal osteoarthritis	1/311 (0.3%)
Osteochondrosis	1/311 (0.3%)
Pain in extremity	1/311 (0.3%)
Sjogren's syndrome	1/311 (0.3%)
Spinal column stenosis	1/311 (0.3%)
Spinal disorder	1/311 (0.3%)
Synovial cyst	1/311 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign	17/311 (5.5%)
Pituitary tumour	7/311 (2.3%)
Neoplasm progression	5/311 (1.6%)
Benign colonic neoplasm	2/311 (0.6%)
Colon cancer	2/311 (0.6%)
Lipoma	2/311 (0.6%)
Pituitary tumour recurrent	2/311 (0.6%)
Benign neoplasm of skin	1/311 (0.3%)
Breast cancer female	1/311 (0.3%)
Bronchioloalveolar carcinoma	1/311 (0.3%)
Cholesteatoma	1/311 (0.3%)
Extragonadal primary malignant teratoma	1/311 (0.3%)
Gastric cancer	1/311 (0.3%)
Glioblastoma	1/311 (0.3%)
Lung squamous cell carcinoma stage unspecified	1/311 (0.3%)
Meningioma	1/311 (0.3%)
Metastases to abdominal wall	1/311 (0.3%)
Papillary thyroid cancer	1/311 (0.3%)
Prostate cancer	1/311 (0.3%)
Recurrent cancer	1/311 (0.3%)
Renal cancer	1/311 (0.3%)
Renal cell carcinoma	1/311 (0.3%)
Respiratory tract neoplasm	1/311 (0.3%)
Transitional cell carcinoma	1/311 (0.3%)
Ureteral neoplasm	1/311 (0.3%)
Uterine leiomyoma	1/311 (0.3%)
Nervous system disorders
Headache	13/311 (4.2%)
Epilepsy	3/311 (1%)
Hyposmia	2/311 (0.6%)
Sciatica	2/311 (0.6%)
Anosmia	1/311 (0.3%)
Carpal tunnel syndrome	1/311 (0.3%)
Cerebral infarction	1/311 (0.3%)
Cerebrospinal fistula	1/311 (0.3%)
Cerebrospinal fluid rhinorrhoea	1/311 (0.3%)
Chiasma syndrome	1/311 (0.3%)
Disturbance in attention	1/311 (0.3%)
Dysaesthesia	1/311 (0.3%)
Hypoaesthesia	1/311 (0.3%)
IIIrd nerve paralysis	1/311 (0.3%)
Memory impairment	1/311 (0.3%)
Polyneuropathy	1/311 (0.3%)
Reversible ischaemic neurological deficit	1/311 (0.3%)
Spinal cord compression	1/311 (0.3%)
Transient ischaemic attack	1/311 (0.3%)
Visual field defect	1/311 (0.3%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	1/311 (0.3%)
Pregnancy	1/311 (0.3%)
Psychiatric disorders
Loss of libido	2/311 (0.6%)
Depressed mood	1/311 (0.3%)
Depression	1/311 (0.3%)
Middle insomnia	1/311 (0.3%)
Restlessness	1/311 (0.3%)
Renal and urinary disorders
Diabetic nephropathy	1/311 (0.3%)
Hydronephrosis	1/311 (0.3%)
Renal arteriosclerosis	1/311 (0.3%)
Renal atrophy	1/311 (0.3%)
Renal cyst	1/311 (0.3%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	3/311 (1%)
Gynaecomastia	1/311 (0.3%)
Menorrhagia	1/311 (0.3%)
Prostatism	1/311 (0.3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/311 (0.6%)
Dyspnoea	2/311 (0.6%)
Pulmonary embolism	2/311 (0.6%)
Asthma	1/311 (0.3%)
Bronchial irritation	1/311 (0.3%)
Dysphonia	1/311 (0.3%)
Skin and subcutaneous tissue disorders
Lipohypertrophy	4/311 (1.3%)
Alopecia	2/311 (0.6%)
Erythema	1/311 (0.3%)
Rash	1/311 (0.3%)
Rash pruritic	1/311 (0.3%)
Surgical and medical procedures
Cholecystectomy	8/311 (2.6%)
Pituitary tumour removal	8/311 (2.6%)
Radiotherapy	5/311 (1.6%)
Radiotherapy to brain	2/311 (0.6%)
Appendicectomy	1/311 (0.3%)
Cardiac pacemaker insertion	1/311 (0.3%)
Gallbladder operation	1/311 (0.3%)
Gastrectomy	1/311 (0.3%)
Hypophysectomy	1/311 (0.3%)
Hysterectomy	1/311 (0.3%)
Knee arthroplasty	1/311 (0.3%)
Knee operation	1/311 (0.3%)
Laparoscopic surgery	1/311 (0.3%)
Nephrectomy	1/311 (0.3%)
Pituitary gland radiotherapy	1/311 (0.3%)
Polypectomy	1/311 (0.3%)
Therapy regimen changed	1/311 (0.3%)
Umbilical hernia repair	1/311 (0.3%)
Vascular disorders
Hypertension	12/311 (3.9%)
Deep vein thrombosis	3/311 (1%)
Hypertensive crisis	1/311 (0.3%)
Macroangiopathy	1/311 (0.3%)
Peripheral circulatory failure	1/311 (0.3%)
Thrombophlebitis superficial	1/311 (0.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.