Trial Outcomes & Findings for Non Interventional Study For Patients Treated With Somavert® (NCT NCT00858143)
NCT ID: NCT00858143
Last Updated: 2009-09-02
Results Overview
Long term safety of Somavert in treatment of patients with acromegaly
COMPLETED
311 participants
Baseline up to 5 years
2009-09-02
Participant Flow
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.
Participant milestones
| Measure |
Somavert®
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Overall Study
STARTED
|
311
|
|
Overall Study
COMPLETED
|
261
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Somavert®
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Death
|
7
|
|
Overall Study
Other
|
23
|
Baseline Characteristics
Non Interventional Study For Patients Treated With Somavert®
Baseline characteristics by cohort
| Measure |
Somavert®
n=311 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Age Continuous
|
50.3 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Safety Population; all patients who received at least one dose of Somavert® during the observation period.
Long term safety of Somavert in treatment of patients with acromegaly
Outcome measures
| Measure |
Somavert®
n=311 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Serious Adverse Events (SAE) and Adverse Events (AE)
Serious Adverse Events (SAE's)
|
116 participants
|
|
Serious Adverse Events (SAE) and Adverse Events (AE)
Adverse Events (AE's)
|
197 participants
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: 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).
Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Follow-up 1 (n=243)
|
-200.3 micrograms per liter (ug/l)
Standard Deviation 239.1
|
|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Follow-up 2 (n=202)
|
-202.6 micrograms per liter (ug/l)
Standard Deviation 327.7
|
|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Follow-up 3 (n=131)
|
-273.7 micrograms per liter (ug/l)
Standard Deviation 251.3
|
|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Follow-up 4 (n=71)
|
-319.6 micrograms per liter (ug/l)
Standard Deviation 234.7
|
|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Follow-up 5 (n=18)
|
-296.6 micrograms per liter (ug/l)
Standard Deviation 189.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants who have IGF-I values within normal range (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
IGF-I Values Within Normal Range
Baseline (n=266)
|
59 participant
|
|
IGF-I Values Within Normal Range
Follow-up 1 (n=261)
|
156 participant
|
|
IGF-I Values Within Normal Range
Follow-up 2 (n=222)
|
154 participant
|
|
IGF-I Values Within Normal Range
Follow-up 3 (n=147)
|
108 participant
|
|
IGF-I Values Within Normal Range
Follow-up 4 (n=79)
|
56 participant
|
|
IGF-I Values Within Normal Range
Follow-up 5 (n=21)
|
14 participant
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants who have IGF-I values above normal range (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
IGF-I Values Above Normal Range
Baseline (n=266)
|
207 participant
|
|
IGF-I Values Above Normal Range
Follow-up 1 (n=261)
|
105 participant
|
|
IGF-I Values Above Normal Range
Follow-up 2 (n=222)
|
68 participant
|
|
IGF-I Values Above Normal Range
Follow-up 3 (n=147)
|
39 participant
|
|
IGF-I Values Above Normal Range
Follow-up 4 (n=79)
|
23 participant
|
|
IGF-I Values Above Normal Range
Follow-up 5 (n=21)
|
7 participant
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Change: HbA 1c at observation minus HbA 1c at baseline.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
Follow-up 1 (n=124)
|
-0.3 percent (%)
Standard Deviation 0.9
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
Follow-up 2 (n=123)
|
-0.3 percent (%)
Standard Deviation 1.0
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
Follow-up 3 (n=80)
|
-0.3 percent (%)
Standard Deviation 1.1
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
Follow-up 4 (n=41)
|
-0.3 percent (%)
Standard Deviation 1.6
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
Follow-up 5 (n=10)
|
-0.0 percent (%)
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants who have HbA 1c values within normal range.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
HbA 1c Values Within Normal Range
Baseline (n=173)
|
104 participant
|
|
HbA 1c Values Within Normal Range
Follow-up 1 (n=132)
|
85 participant
|
|
HbA 1c Values Within Normal Range
Follow-up 2 (n=127)
|
78 participant
|
|
HbA 1c Values Within Normal Range
Follow-up 3 (n=82)
|
57 participant
|
|
HbA 1c Values Within Normal Range
Follow-up 4 (n=43)
|
30 participant
|
|
HbA 1c Values Within Normal Range
Follow-up 5 (n=10)
|
7 participant
|
SECONDARY outcome
Timeframe: 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)Population: 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).
Number of participants who have HbA 1c values below normal range.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
HbA 1c Values Below Normal Range
Baseline (n=173)
|
0 participants
|
|
HbA 1c Values Below Normal Range
Follow-up 1 (n=132)
|
1 participants
|
|
HbA 1c Values Below Normal Range
Follow-up 2 (n=127)
|
1 participants
|
|
HbA 1c Values Below Normal Range
Follow-up 3 (n=82)
|
1 participants
|
|
HbA 1c Values Below Normal Range
Follow-up 4 (n=43)
|
0 participants
|
|
HbA 1c Values Below Normal Range
Follow-up 5 (n=10)
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants with HbA 1c values above normal range.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
HbA 1c Values Above Normal Range
Follow-up 5 (n=10)
|
3 participants
|
|
HbA 1c Values Above Normal Range
Baseline (n=173)
|
69 participants
|
|
HbA 1c Values Above Normal Range
Follow-up 1 (n=132)
|
46 participants
|
|
HbA 1c Values Above Normal Range
Follow-up 2 (n=127)
|
48 participants
|
|
HbA 1c Values Above Normal Range
Follow-up 3 (n=82)
|
24 participants
|
|
HbA 1c Values Above Normal Range
Follow-up 4 (n=43)
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Change: glucose at observation minus glucose at baseline.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline Glucose (Fasting)
Follow-up 1 (n=121)
|
-11.6 milligram per deciliter (mg/dl)
Standard Deviation 39.6
|
|
Change From Baseline Glucose (Fasting)
Follow-up 2 (n=103)
|
-14.2 milligram per deciliter (mg/dl)
Standard Deviation 40.1
|
|
Change From Baseline Glucose (Fasting)
Follow-up 3 (n=70)
|
-19.7 milligram per deciliter (mg/dl)
Standard Deviation 45.7
|
|
Change From Baseline Glucose (Fasting)
Follow-up 4 (n=33)
|
-12.9 milligram per deciliter (mg/dl)
Standard Deviation 51.0
|
|
Change From Baseline Glucose (Fasting)
Follow-up 5 (n=8)
|
-10.5 milligram per deciliter (mg/dl)
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)Population: 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).
Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Follow-up 1 (n=3)
|
-1.5 milligram per deciliter (mg/dl)
Standard Deviation 38.7
|
|
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Follow-up 2 (n=2)
|
-56.8 milligram per deciliter (mg/dl)
Standard Deviation 85.4
|
|
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Follow-up 3 (n=2)
|
-61.3 milligram per deciliter (mg/dl)
Standard Deviation 79.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants who have glucose values within normal range (fasting).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose Values Within Normal Range (Fasting)
Baseline (n=172)
|
116 participants
|
|
Glucose Values Within Normal Range (Fasting)
Follow-up 1 (n=132)
|
103 participants
|
|
Glucose Values Within Normal Range (Fasting)
Follow-up 2 (n=117)
|
93 participants
|
|
Glucose Values Within Normal Range (Fasting)
Follow-up 3 (n=78)
|
65 participants
|
|
Glucose Values Within Normal Range (Fasting)
Follow-up 4 (n=35)
|
25 participants
|
|
Glucose Values Within Normal Range (Fasting)
Follow-up 5 (n=8)
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants with glucose values below normal range (fasting).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose Values Below Normal Range (Fasting)
Baseline (n=172)
|
2 participants
|
|
Glucose Values Below Normal Range (Fasting)
Follow-up 1 (n=132)
|
3 participants
|
|
Glucose Values Below Normal Range (Fasting)
Follow-up 2 (n=117)
|
1 participants
|
|
Glucose Values Below Normal Range (Fasting)
Follow-up 3 (n=78)
|
1 participants
|
|
Glucose Values Below Normal Range (Fasting)
Follow-up 4 (n=35)
|
0 participants
|
|
Glucose Values Below Normal Range (Fasting)
Follow-up 5 (n=8)
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants with glucose values above normal range (fasting).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose Values Above Normal Range (Fasting)
Baseline (n=172)
|
54 participants
|
|
Glucose Values Above Normal Range (Fasting)
Follow-up 1 (n=132)
|
26 participants
|
|
Glucose Values Above Normal Range (Fasting)
Follow-up 2 (n=117)
|
23 participants
|
|
Glucose Values Above Normal Range (Fasting)
Follow-up 3 (n=78)
|
12 participants
|
|
Glucose Values Above Normal Range (Fasting)
Follow-up 4 (n=35)
|
10 participants
|
|
Glucose Values Above Normal Range (Fasting)
Follow-up 5 (n=8)
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants with glucose values (2h oGTT) within normal range.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Follow-up 1 (n=4)
|
3 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Follow-up 2 (n=3)
|
3 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Follow-up 3 (n=3)
|
3 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Baseline (n=7)
|
5 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Follow-up 4 (n=0)
|
0 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Follow-up 5 (n=0)
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of participants with glucose values (2h oGTT) above normal range.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Baseline (n=7)
|
2 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Follow-up 1 (n=4)
|
1 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Follow-up 2 (n=3)
|
0 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Follow-up 3 (n=3)
|
0 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Follow-up 4 (n=0)
|
0 participants
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Follow-up 5 (n=0)
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
IGF-I absolute values (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
IGF-I Absolute Values
Baseline (n=252)
|
480.1 micrograms per liter (ug/l)
Standard Deviation 249.5
|
|
IGF-I Absolute Values
Follow-up 1 (n=243)
|
277.2 micrograms per liter (ug/l)
Standard Deviation 160.5
|
|
IGF-I Absolute Values
Follow-up 2 (n=202)
|
281.6 micrograms per liter (ug/l)
Standard Deviation 285.0
|
|
IGF-I Absolute Values
Follow-up 3 (n=131)
|
240.6 micrograms per liter (ug/l)
Standard Deviation 134.7
|
|
IGF-I Absolute Values
Follow-up 4 (n=71)
|
236.1 micrograms per liter (ug/l)
Standard Deviation 124.2
|
|
IGF-I Absolute Values
Follow-up 5 (n=18)
|
241.8 micrograms per liter (ug/l)
Standard Deviation 107.4
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Absolute Glucose values (fasting)
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Absolute Glucose Values (Fasting)
Baseline (n=158)
|
112.6 milligram per deciliter (mg/dl)
Standard Deviation 44.3
|
|
Absolute Glucose Values (Fasting)
Follow-up 1 (n=121)
|
104.5 milligram per deciliter (mg/dl)
Standard Deviation 42.6
|
|
Absolute Glucose Values (Fasting)
Follow-up 2 (n=103)
|
98.7 milligram per deciliter (mg/dl)
Standard Deviation 34.0
|
|
Absolute Glucose Values (Fasting)
Follow-up 3 (n=70)
|
95.2 milligram per deciliter (mg/dl)
Standard Deviation 17.6
|
|
Absolute Glucose Values (Fasting)
Follow-up 4 (n=33)
|
105.9 milligram per deciliter (mg/dl)
Standard Deviation 42.7
|
|
Absolute Glucose Values (Fasting)
Follow-up 5 (n=8)
|
107.5 milligram per deciliter (mg/dl)
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Absolute Glucose Values (2h oGTT)
Baseline (n=5)
|
130.6 milligram per deciliter (mg/dl)
Standard Deviation 60.2
|
|
Absolute Glucose Values (2h oGTT)
Follow-up 1 (n=3)
|
145.3 milligram per deciliter (mg/dl)
Standard Deviation 71.8
|
|
Absolute Glucose Values (2h oGTT)
Follow-up 2 (n=2)
|
108.1 milligram per deciliter (mg/dl)
Standard Deviation 10.2
|
|
Absolute Glucose Values (2h oGTT)
Follow-up 3 (n=2)
|
112.6 milligram per deciliter (mg/dl)
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Absolute value Hemoglobin A 1c (HbA 1c)
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Baseline (n=166)
|
6.2 percent (%)
Standard Deviation 1.2
|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Follow-up 1 (n=124)
|
6.0 percent (%)
Standard Deviation 1.1
|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Follow-up 2 (n=123)
|
6.1 percent (%)
Standard Deviation 1.1
|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Follow-up 3 (n=80)
|
6.0 percent (%)
Standard Deviation 1.1
|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Follow-up 4 (n=41)
|
6.1 percent (%)
Standard Deviation 1.1
|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Follow-up 5 (n=10)
|
6.1 percent (%)
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 1 (n=75)
|
-207.5 micrograms per liter (ug/l)
Interval -263.6 to -151.3
|
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 2 (n=67)
|
-194.5 micrograms per liter (ug/l)
Interval -257.4 to -131.6
|
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 3 (n=44)
|
-274.6 micrograms per liter (ug/l)
Interval -353.9 to -195.4
|
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 4 (n=24)
|
-314.9 micrograms per liter (ug/l)
Interval -433.6 to -196.2
|
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 5 (n=4)
|
-90.5 micrograms per liter (ug/l)
Interval -348.8 to 167.74
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Baseline (n=78)
|
478.8 micrograms per liter (ug/l)
Standard Deviation 264.6
|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 1 (n=75)
|
276.4 micrograms per liter (ug/l)
Standard Deviation 145.9
|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 2 (n=67)
|
293.2 micrograms per liter (ug/l)
Standard Deviation 212.3
|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 3 (n=44)
|
239.3 micrograms per liter (ug/l)
Standard Deviation 142.6
|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 4 (n=24)
|
242.5 micrograms per liter (ug/l)
Standard Deviation 115.5
|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Follow-up 5 (n=4)
|
311.3 micrograms per liter (ug/l)
Standard Deviation 203.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Baseline (n=81)
|
14 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Follow-up 1 (n=80)
|
41 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Follow-up 2 (n=74)
|
47 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Follow-up 3 (n=49)
|
35 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Follow-up 4 (n=26)
|
16 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Follow-up 5 (n=5)
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Baseline (n=81)
|
67 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Follow-up 1 (n=80)
|
39 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Follow-up 2 (n=74)
|
27 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Follow-up 3 (n=49)
|
14 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Follow-up 4 (n=26)
|
10 participants
|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Follow-up 5 (n=5)
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Baseline (n=67)
|
7.0 percent (%)
Standard Deviation 1.4
|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 1 (n=58)
|
6.6 percent (%)
Standard Deviation 1.2
|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 2 (n=60)
|
6.5 percent (%)
Standard Deviation 1.2
|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 3 (n=36)
|
6.6 percent (%)
Standard Deviation 1.3
|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 4 (n=21)
|
6.6 percent (%)
Standard Deviation 1.3
|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 5 (n=5)
|
6.6 percent (%)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Change: HbA 1c at observation minus HbA 1c at baseline.
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 1 (n=58)
|
-0.4 percent (%)
Interval -0.8 to -0.1
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 2 (n=60)
|
-0.5 percent (%)
Interval -0.8 to -0.2
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 3 (n=36)
|
-0.5 percent (%)
Interval -1.0 to 0.0
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 4 (n=21)
|
-0.6 percent (%)
Interval -1.6 to 0.4
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Follow-up 5 (n=5)
|
-0.2 percent (%)
Interval -1.3 to 0.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients with HbA 1c Values Within Normal Range.
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
HbA 1c Values Within Normal Range in Diabetic Patients
Baseline (n=72)
|
24 participants
|
|
HbA 1c Values Within Normal Range in Diabetic Patients
Follow-up 1 (n=64)
|
25 participants
|
|
HbA 1c Values Within Normal Range in Diabetic Patients
Follow-up 2 (n=62)
|
24 participants
|
|
HbA 1c Values Within Normal Range in Diabetic Patients
Follow-up 3 (n=38)
|
17 participants
|
|
HbA 1c Values Within Normal Range in Diabetic Patients
Follow-up 4 (n=22)
|
10 participants
|
|
HbA 1c Values Within Normal Range in Diabetic Patients
Follow-up 5 (n=5)
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients with HbA 1c Values Below Normal Range
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
HbA 1c Values Below Normal Range in Diabetic Patients
Baseline (n=72)
|
0 participant
|
|
HbA 1c Values Below Normal Range in Diabetic Patients
Follow-up 1 (n=64)
|
1 participant
|
|
HbA 1c Values Below Normal Range in Diabetic Patients
Follow-up 2 (n=62)
|
1 participant
|
|
HbA 1c Values Below Normal Range in Diabetic Patients
Follow-up 3 (n=38)
|
0 participant
|
|
HbA 1c Values Below Normal Range in Diabetic Patients
Follow-up 4 (n=22)
|
0 participant
|
|
HbA 1c Values Below Normal Range in Diabetic Patients
Follow-up 5 (n=5)
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients with HbA 1c Values Above Normal Range
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
HbA 1c Values Above Normal Range in Diabetic Patients
Baseline (n=72)
|
48 participant
|
|
HbA 1c Values Above Normal Range in Diabetic Patients
Follow-up 1 (n=64)
|
38 participant
|
|
HbA 1c Values Above Normal Range in Diabetic Patients
Follow-up 2 (n=62)
|
37 participant
|
|
HbA 1c Values Above Normal Range in Diabetic Patients
Follow-up 3 (n=38)
|
21 participant
|
|
HbA 1c Values Above Normal Range in Diabetic Patients
Follow-up 4 (n=22)
|
12 participant
|
|
HbA 1c Values Above Normal Range in Diabetic Patients
Follow-up 5 (n=5)
|
2 participant
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Change: glucose at observation minus glucose at baseline
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
Follow-up 1 (n=42)
|
-17.2 milligram per deciliter (mg/dl)
Interval -35.6 to 1.1
|
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
Follow-up 2 (n=37)
|
-24.9 milligram per deciliter (mg/dl)
Interval -44.2 to -5.6
|
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
Follow-up 3 (n=21)
|
-50.7 milligram per deciliter (mg/dl)
Interval -81.4 to -20.0
|
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
Follow-up 4 (n=13)
|
-14.8 milligram per deciliter (mg/dl)
Interval -62.5 to 32.9
|
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
Follow-up 5 (n=3)
|
-17.7 milligram per deciliter (mg/dl)
Interval -76.7 to 41.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Absolute Glucose Values in Patients with Diabetes (fasting)
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Baseline (n=51)
|
142.1 milligram per deciliter (mg/dl)
Standard Deviation 62.3
|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Follow-up 1 (n=42)
|
131.0 milligram per deciliter (mg/dl)
Standard Deviation 59.4
|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Follow-up 2 (n=37)
|
112.9 milligram per deciliter (mg/dl)
Standard Deviation 49.7
|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Follow-up 3 (n=21)
|
101.9 milligram per deciliter (mg/dl)
Standard Deviation 21.7
|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Follow-up 4 (n=13)
|
130.6 milligram per deciliter (mg/dl)
Standard Deviation 58.9
|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Follow-up 5 (n=3)
|
120.7 milligram per deciliter (mg/dl)
Standard Deviation 52.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Baseline (n= 57)
|
24 participants
|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Follow-up 1 (n=47)
|
28 participants
|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Follow-up 2 (n=42)
|
25 participants
|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Follow-up 3 (n=25)
|
18 participants
|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Follow-up 4 (n=14)
|
6 participants
|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Follow-up 5 (n=3)
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range
Outcome measures
| Measure |
Somavert®
n=192 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Baseline (n=57)
|
33 participants
|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Follow-up 1 (n=47)
|
19 participants
|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Follow-up 2 (n=42)
|
17 participants
|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Follow-up 3 (n=25)
|
7 participants
|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Follow-up 4 (n=14)
|
8 participants
|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Follow-up 5 (n=3)
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=107)
|
-0.3 score on scale
Interval -0.7 to 0.1
|
|
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=89)
|
-0.4 score on scale
Interval -0.8 to 0.1
|
|
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=60)
|
-0.2 score on scale
Interval -0.6 to 0.2
|
|
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-0.7 score on scale
Interval -2.5 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=108)
|
-0.1 score on scale
Interval -0.6 to 0.3
|
|
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=89)
|
-0.4 score on scale
Interval -0.9 to 0.2
|
|
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=60)
|
-0.0 score on scale
Interval -0.8 to 0.7
|
|
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-0.8 score on scale
Interval -2.8 to 1.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=108)
|
-0.6 score on scale
Interval -1.0 to -0.2
|
|
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=89)
|
-0.2 score on scale
Interval -0.8 to 0.4
|
|
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=60)
|
0.0 score on scale
Interval -0.5 to 0.6
|
|
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
0.6 score on scale
Interval -1.1 to 2.2
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=106)
|
0.2 score on scale
Interval -0.2 to 0.6
|
|
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=88)
|
-0.5 score on scale
Interval -0.9 to 0.0
|
|
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=59)
|
-0.4 score on scale
Interval -1.0 to 0.3
|
|
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-0.4 score on scale
Interval -1.6 to 0.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=105)
|
-0.6 score on scale
Interval -1.0 to -0.2
|
|
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=88)
|
-0.8 score on scale
Interval -1.4 to -0.2
|
|
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=60)
|
-0.8 score on scale
Interval -1.5 to -0.1
|
|
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-1.2 score on scale
Interval -3.1 to 0.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=60)
|
-0.6 score on scale
Interval -1.2 to 0.0
|
|
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-0.8 score on scale
Interval -2.0 to 0.4
|
|
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=108)
|
-0.7 score on scale
Interval -1.0 to -0.4
|
|
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=89)
|
-0.6 score on scale
Interval -1.0 to -0.2
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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).
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=106)
|
-0.6 score on scale
Interval -0.9 to -0.2
|
|
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=89)
|
-0.6 score on scale
Interval -1.1 to -0.2
|
|
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=59)
|
-0.6 score on scale
Interval -1.3 to 0.1
|
|
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-0.5 score on scale
Interval -2.2 to 1.2
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)Population: 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.
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.
Outcome measures
| Measure |
Somavert®
n=131 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 1 (n=107)
|
-2.3 score on scale
Interval -3.7 to -0.9
|
|
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 2 (n=89)
|
-2.7 score on scale
Interval -4.6 to -0.8
|
|
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 3 (n=60)
|
-2.0 score on scale
Interval -4.4 to 0.5
|
|
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Follow-up 4 (n=14)
|
-3.5 score on scale
Interval -9.8 to 2.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)Population: 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).
Change: body weight at observation minus body weight at baseline
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Mean Change From Baseline for Body Weight
Follow-up 1 (n=213)
|
0.0 kilogram (kg)
Standard Deviation 5.2
|
|
Mean Change From Baseline for Body Weight
Follow-up 2 (n=185)
|
0.6 kilogram (kg)
Standard Deviation 6.0
|
|
Mean Change From Baseline for Body Weight
Follow-up 3 (n=118)
|
2.1 kilogram (kg)
Standard Deviation 7.4
|
|
Mean Change From Baseline for Body Weight
Follow-up 4 (n=61)
|
1.6 kilogram (kg)
Standard Deviation 7.7
|
|
Mean Change From Baseline for Body Weight
Follow-up 5 (n=13)
|
3.0 kilogram (kg)
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)Population: 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).
Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline for Diastolic Blood Pressure (BP)
Follow-up 1 (n=217)
|
-1.0 millimeters per mercury (mmHg)
Standard Deviation 11.0
|
|
Change From Baseline for Diastolic Blood Pressure (BP)
Follow-up 2 (n=189)
|
-1.2 millimeters per mercury (mmHg)
Standard Deviation 13.0
|
|
Change From Baseline for Diastolic Blood Pressure (BP)
Follow-up 3 (n=124)
|
-1.5 millimeters per mercury (mmHg)
Standard Deviation 13.4
|
|
Change From Baseline for Diastolic Blood Pressure (BP)
Follow-up 4 (n=64)
|
1.8 millimeters per mercury (mmHg)
Standard Deviation 15.2
|
|
Change From Baseline for Diastolic Blood Pressure (BP)
Follow-up 5 (n=15)
|
2.5 millimeters per mercury (mmHg)
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)Population: 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).
Change: systolic blood pressure at observation minus systolic blood pressure at baseline
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline for Systolic Blood Pressure (BP)
Follow-up 1 (n=217)
|
-0.1 millimeters Mercury (mmHg)
Standard Deviation 17.2
|
|
Change From Baseline for Systolic Blood Pressure (BP)
Follow-up 2 (n=189)
|
-2.9 millimeters Mercury (mmHg)
Standard Deviation 18.1
|
|
Change From Baseline for Systolic Blood Pressure (BP)
Follow-up 3 (n=124)
|
-4.3 millimeters Mercury (mmHg)
Standard Deviation 19.2
|
|
Change From Baseline for Systolic Blood Pressure (BP)
Follow-up 4 (n=65)
|
2.1 millimeters Mercury (mmHg)
Standard Deviation 21.4
|
|
Change From Baseline for Systolic Blood Pressure (BP)
Follow-up 5 (n=15)
|
8.4 millimeters Mercury (mmHg)
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
Change from baseline: ring size at observation minus ring size at baseline
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Change From Baseline in Ring Size
Follow-up 1 (n=99)
|
0.2 millimeters
Standard Deviation 4.7
|
|
Change From Baseline in Ring Size
Follow-up 2 (n=82)
|
-0.8 millimeters
Standard Deviation 8.3
|
|
Change From Baseline in Ring Size
Follow-up 3 (n=37)
|
-0.3 millimeters
Standard Deviation 11.8
|
|
Change From Baseline in Ring Size
Follow-up 4 (n=16)
|
-6.1 millimeters
Standard Deviation 15.7
|
|
Change From Baseline in Ring Size
Follow-up 5 (n=2)
|
0.0 millimeters
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).
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.
Outcome measures
| Measure |
Somavert®
n=305 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
|
16.8 milligram (mg)
|
SECONDARY outcome
Timeframe: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)Population: 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).
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.
Outcome measures
| Measure |
Somavert®
n=270 Participants
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
|
16.4 milligram (mg)
|
Adverse Events
Somavert®
Serious adverse events
| Measure |
Somavert®
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
5.1%
16/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
2.3%
7/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.6%
5/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.64%
2/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
0.64%
2/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extragonadal primary malignant teratoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory tract neoplasm
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.32%
1/311
|
|
Surgical and medical procedures
Cholecystectomy
|
2.6%
8/311
|
|
Surgical and medical procedures
Pituitary tumour removal
|
2.6%
8/311
|
|
Surgical and medical procedures
Appendicectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.32%
1/311
|
|
Surgical and medical procedures
Gallbladder operation
|
0.32%
1/311
|
|
Surgical and medical procedures
Gastrectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Hysterectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.32%
1/311
|
|
Surgical and medical procedures
Knee operation
|
0.32%
1/311
|
|
Surgical and medical procedures
Laparoscopic surgery
|
0.32%
1/311
|
|
Surgical and medical procedures
Nephrectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Pituitary gland radiotherapy
|
0.32%
1/311
|
|
Surgical and medical procedures
Radiotherapy
|
0.32%
1/311
|
|
Surgical and medical procedures
Radiotherapy to brain
|
0.32%
1/311
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.32%
1/311
|
|
Investigations
Hepatic enzyme increased
|
4.2%
13/311
|
|
Investigations
Transaminases increased
|
2.3%
7/311
|
|
Investigations
Insulin-like growth factor increased
|
0.64%
2/311
|
|
Investigations
Alanine aminotransferase increased
|
0.32%
1/311
|
|
Investigations
blood creatine phosphokinase increased
|
0.32%
1/311
|
|
Investigations
Colonoscopy
|
0.32%
1/311
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.32%
1/311
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
9/311
|
|
Hepatobiliary disorders
Bile duct stone
|
0.64%
2/311
|
|
Hepatobiliary disorders
Biliary colic
|
0.64%
2/311
|
|
Hepatobiliary disorders
Cholangitis
|
0.64%
2/311
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.64%
2/311
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/311
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/311
|
|
Gastrointestinal disorders
Pancreatitis
|
0.96%
3/311
|
|
Gastrointestinal disorders
Colitis
|
0.32%
1/311
|
|
Gastrointestinal disorders
Colonic polyp
|
0.32%
1/311
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.32%
1/311
|
|
Gastrointestinal disorders
Ileus
|
0.32%
1/311
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/311
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.32%
1/311
|
|
Nervous system disorders
Epilepsy
|
0.96%
3/311
|
|
Nervous system disorders
Anosmia
|
0.32%
1/311
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.32%
1/311
|
|
Nervous system disorders
Cerebrospinal fluid rhinorrhoea
|
0.32%
1/311
|
|
Nervous system disorders
Chiasma syndrome
|
0.32%
1/311
|
|
Nervous system disorders
Hypoaesthesia
|
0.32%
1/311
|
|
Nervous system disorders
Hyposmia
|
0.32%
1/311
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.32%
1/311
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/311
|
|
Cardiac disorders
Aortic valve incompetence
|
0.64%
2/311
|
|
Cardiac disorders
Tachyarrhythmia
|
0.64%
2/311
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/311
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/311
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.32%
1/311
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/311
|
|
Cardiac disorders
Cardiac failure
|
0.32%
1/311
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/311
|
|
Cardiac disorders
Cyanosis
|
0.32%
1/311
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/311
|
|
Cardiac disorders
Ventricular fibrillation
|
0.32%
1/311
|
|
Cardiac disorders
Ventricular tachycardia
|
0.32%
1/311
|
|
General disorders
Cardiac death
|
0.64%
2/311
|
|
General disorders
Application site necrosis
|
0.32%
1/311
|
|
General disorders
Condition aggravated
|
0.32%
1/311
|
|
General disorders
Disease progression
|
0.32%
1/311
|
|
General disorders
No adverse event
|
0.32%
1/311
|
|
General disorders
Pain
|
0.32%
1/311
|
|
Vascular disorders
Deep vein thrombosis
|
0.96%
3/311
|
|
Vascular disorders
Hypertension
|
0.64%
2/311
|
|
Vascular disorders
Hypertensive crisis
|
0.32%
1/311
|
|
Vascular disorders
Peripheral circulatory failure
|
0.32%
1/311
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.64%
2/311
|
|
Endocrine disorders
Toxic nodular goitre
|
0.64%
2/311
|
|
Endocrine disorders
Hypopituitarism
|
0.32%
1/311
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
2/311
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.64%
2/311
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.64%
2/311
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.32%
1/311
|
|
Infections and infestations
Infection
|
0.64%
2/311
|
|
Infections and infestations
Pneumonia
|
0.64%
2/311
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.32%
1/311
|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/311
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.32%
1/311
|
|
Eye disorders
Blindness transient
|
0.32%
1/311
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.32%
1/311
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.32%
1/311
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.32%
1/311
|
|
Renal and urinary disorders
Hydronephrosis
|
0.32%
1/311
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.32%
1/311
|
Other adverse events
| Measure |
Somavert®
Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
|
|---|---|
|
Investigations
Hepatic enzyme increased
|
6.8%
21/311
|
|
Investigations
Transaminases increased
|
3.5%
11/311
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
4/311
|
|
Investigations
Insulin-like growth factor increased
|
0.96%
3/311
|
|
Investigations
Aspartate aminotransferase increased
|
0.64%
2/311
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.64%
2/311
|
|
Investigations
Weight increased
|
0.64%
2/311
|
|
Investigations
Analgesic drug level increased
|
0.32%
1/311
|
|
Investigations
Blood creatine phosphokinase increased
|
0.32%
1/311
|
|
Investigations
Blood pressure increased
|
0.32%
1/311
|
|
Investigations
Colonoscopy
|
0.32%
1/311
|
|
Investigations
Waist circumference increased
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
5.5%
17/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
2.3%
7/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.6%
5/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.64%
2/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.64%
2/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.64%
2/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
0.64%
2/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extragonadal primary malignant teratoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory tract neoplasm
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.32%
1/311
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.32%
1/311
|
|
Surgical and medical procedures
Cholecystectomy
|
2.6%
8/311
|
|
Surgical and medical procedures
Pituitary tumour removal
|
2.6%
8/311
|
|
Surgical and medical procedures
Radiotherapy
|
1.6%
5/311
|
|
Surgical and medical procedures
Radiotherapy to brain
|
0.64%
2/311
|
|
Surgical and medical procedures
Appendicectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.32%
1/311
|
|
Surgical and medical procedures
Gallbladder operation
|
0.32%
1/311
|
|
Surgical and medical procedures
Gastrectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Hypophysectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Hysterectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.32%
1/311
|
|
Surgical and medical procedures
Knee operation
|
0.32%
1/311
|
|
Surgical and medical procedures
Laparoscopic surgery
|
0.32%
1/311
|
|
Surgical and medical procedures
Nephrectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Pituitary gland radiotherapy
|
0.32%
1/311
|
|
Surgical and medical procedures
Polypectomy
|
0.32%
1/311
|
|
Surgical and medical procedures
Therapy regimen changed
|
0.32%
1/311
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.32%
1/311
|
|
General disorders
Fat tissue increased
|
1.6%
5/311
|
|
General disorders
Injection site erythema
|
1.6%
5/311
|
|
General disorders
Disease progression
|
1.3%
4/311
|
|
General disorders
Cardiac death
|
0.64%
2/311
|
|
General disorders
Fatigue
|
0.64%
2/311
|
|
General disorders
Injection site hypertrophy
|
0.64%
2/311
|
|
General disorders
Injection site reaction
|
0.64%
2/311
|
|
General disorders
Injection site swelling
|
0.64%
2/311
|
|
General disorders
Pain
|
0.64%
2/311
|
|
General disorders
Adverse drug reaction
|
0.32%
1/311
|
|
General disorders
Application site necrosis
|
0.32%
1/311
|
|
General disorders
Condition aggravated
|
0.32%
1/311
|
|
General disorders
Drug ineffective
|
0.32%
1/311
|
|
General disorders
Facial pain
|
0.32%
1/311
|
|
General disorders
Feeling cold
|
0.32%
1/311
|
|
General disorders
Influenza like illness
|
0.32%
1/311
|
|
General disorders
Injection site induration
|
0.32%
1/311
|
|
General disorders
Injection site oedema
|
0.32%
1/311
|
|
General disorders
Injection site pruritus
|
0.32%
1/311
|
|
General disorders
No adverse event
|
0.32%
1/311
|
|
General disorders
Ulcer
|
0.32%
1/311
|
|
Nervous system disorders
Headache
|
4.2%
13/311
|
|
Nervous system disorders
Epilepsy
|
0.96%
3/311
|
|
Nervous system disorders
Hyposmia
|
0.64%
2/311
|
|
Nervous system disorders
Sciatica
|
0.64%
2/311
|
|
Nervous system disorders
Anosmia
|
0.32%
1/311
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.32%
1/311
|
|
Nervous system disorders
Cerebral infarction
|
0.32%
1/311
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.32%
1/311
|
|
Nervous system disorders
Cerebrospinal fluid rhinorrhoea
|
0.32%
1/311
|
|
Nervous system disorders
Chiasma syndrome
|
0.32%
1/311
|
|
Nervous system disorders
Disturbance in attention
|
0.32%
1/311
|
|
Nervous system disorders
Dysaesthesia
|
0.32%
1/311
|
|
Nervous system disorders
Hypoaesthesia
|
0.32%
1/311
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.32%
1/311
|
|
Nervous system disorders
Memory impairment
|
0.32%
1/311
|
|
Nervous system disorders
Polyneuropathy
|
0.32%
1/311
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.32%
1/311
|
|
Nervous system disorders
Spinal cord compression
|
0.32%
1/311
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/311
|
|
Nervous system disorders
Visual field defect
|
0.32%
1/311
|
|
Gastrointestinal disorders
Constipation
|
1.9%
6/311
|
|
Gastrointestinal disorders
Pancreatitis
|
0.96%
3/311
|
|
Gastrointestinal disorders
Diarrhoea
|
0.64%
2/311
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.64%
2/311
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.32%
1/311
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/311
|
|
Gastrointestinal disorders
Colitis
|
0.32%
1/311
|
|
Gastrointestinal disorders
Colonic polyp
|
0.32%
1/311
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.32%
1/311
|
|
Gastrointestinal disorders
Dyspepsia
|
0.32%
1/311
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gastric cyst
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gastritis
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.32%
1/311
|
|
Gastrointestinal disorders
Gingivitis
|
0.32%
1/311
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.32%
1/311
|
|
Gastrointestinal disorders
Ileus
|
0.32%
1/311
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/311
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/311
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.32%
1/311
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.32%
1/311
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.32%
1/311
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.2%
13/311
|
|
Hepatobiliary disorders
Biliary colic
|
0.96%
3/311
|
|
Hepatobiliary disorders
Bile duct stone
|
0.64%
2/311
|
|
Hepatobiliary disorders
Cholangitis
|
0.64%
2/311
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.64%
2/311
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/311
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/311
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.32%
1/311
|
|
Endocrine disorders
Adrenal insufficiency
|
0.96%
3/311
|
|
Endocrine disorders
Hypopituitarism
|
0.96%
3/311
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.64%
2/311
|
|
Endocrine disorders
Gonadotrophin deficiency
|
0.64%
2/311
|
|
Endocrine disorders
Hypogonadism
|
0.64%
2/311
|
|
Endocrine disorders
Toxic nodular goitre
|
0.64%
2/311
|
|
Endocrine disorders
Diabetes insipidus
|
0.32%
1/311
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.32%
1/311
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.32%
1/311
|
|
Endocrine disorders
Hyperthyroidism
|
0.32%
1/311
|
|
Endocrine disorders
Pituitary haemorrhage
|
0.32%
1/311
|
|
Endocrine disorders
Secondary hypothyroidism
|
0.32%
1/311
|
|
Vascular disorders
Hypertension
|
3.9%
12/311
|
|
Vascular disorders
Deep vein thrombosis
|
0.96%
3/311
|
|
Vascular disorders
Hypertensive crisis
|
0.32%
1/311
|
|
Vascular disorders
Macroangiopathy
|
0.32%
1/311
|
|
Vascular disorders
Peripheral circulatory failure
|
0.32%
1/311
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.96%
3/311
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
2/311
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.64%
2/311
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.64%
2/311
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.32%
1/311
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.96%
3/311
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.96%
3/311
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.64%
2/311
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.64%
2/311
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.64%
2/311
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.32%
1/311
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.32%
1/311
|
|
Infections and infestations
Pneumonia
|
0.96%
3/311
|
|
Metabolism and nutrition disorders
Infection
|
0.64%
2/311
|
|
Infections and infestations
Sinusitis
|
0.64%
2/311
|
|
Infections and infestations
Dermatophytosis
|
0.32%
1/311
|
|
Infections and infestations
Helicobacter gastritis
|
0.32%
1/311
|
|
Infections and infestations
Helicobacter infection
|
0.32%
1/311
|
|
Infections and infestations
Herpes Zoster
|
0.32%
1/311
|
|
Infections and infestations
Lobar pneumonia
|
0.32%
1/311
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/311
|
|
Infections and infestations
Viral infection
|
0.32%
1/311
|
|
Cardiac disorders
Aortic valve incompetence
|
0.64%
2/311
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
2/311
|
|
Cardiac disorders
Cardiac failure
|
0.64%
2/311
|
|
Cardiac disorders
Tachyarrhythmia
|
0.64%
2/311
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/311
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/311
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.32%
1/311
|
|
Cardiac disorders
Arrhythmia
|
0.32%
1/311
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/311
|
|
Cardiac disorders
Cyanosis
|
0.32%
1/311
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/311
|
|
Cardiac disorders
Sinus arrhythmia
|
0.32%
1/311
|
|
Cardiac disorders
Ventricular fibrillation
|
0.32%
1/311
|
|
Cardiac disorders
Ventricular tachycardia
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.64%
2/311
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.32%
1/311
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
1.3%
4/311
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.64%
2/311
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.32%
1/311
|
|
Injury, poisoning and procedural complications
Hyperhidrosis
|
0.32%
1/311
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.32%
1/311
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.32%
1/311
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
2/311
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.64%
2/311
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.64%
2/311
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/311
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial irritation
|
0.32%
1/311
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.32%
1/311
|
|
Psychiatric disorders
Loss of libido
|
0.64%
2/311
|
|
Psychiatric disorders
Depressed mood
|
0.32%
1/311
|
|
Psychiatric disorders
Depression
|
0.32%
1/311
|
|
Psychiatric disorders
Middle insomnia
|
0.32%
1/311
|
|
Psychiatric disorders
Restlessness
|
0.32%
1/311
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.96%
3/311
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.32%
1/311
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.32%
1/311
|
|
Reproductive system and breast disorders
Prostatism
|
0.32%
1/311
|
|
Eye disorders
Visual acuity reduced
|
0.64%
2/311
|
|
Eye disorders
Blindness transient
|
0.32%
1/311
|
|
Eye disorders
Cataract
|
0.32%
1/311
|
|
Eye disorders
Glaucoma
|
0.32%
1/311
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.32%
1/311
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.96%
3/311
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.32%
1/311
|
|
Renal and urinary disorders
Hydronephrosis
|
0.32%
1/311
|
|
Renal and urinary disorders
Renal arteriosclerosis
|
0.32%
1/311
|
|
Renal and urinary disorders
Renal atrophy
|
0.32%
1/311
|
|
Renal and urinary disorders
Renal cyst
|
0.32%
1/311
|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
2/311
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.32%
1/311
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.32%
1/311
|
|
Immune system disorders
House dust allergy
|
0.32%
1/311
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.32%
1/311
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.32%
1/311
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER