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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00658879
• Collaborator: (none)
• Enrollment: 251
• Actual Duration (Months): 111.1

Study Details

Study Description

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: Somavert (Pegvisomant)

Detailed Description

All the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Design

• Study Type: Observational
• Actual Enrollment: 251 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Special Investigation Of Somavert -Long Term Use-
• Actual Study Start Date: Aug 7, 2007
• Actual Primary Completion Date: Nov 9, 2016
• Actual Study Completion Date: Nov 9, 2016

Arms and Interventions

Arm	Intervention/Treatment
Somavert (Pegvisomant) Patients taking Somavert (Pegvisomant).	Drug: Somavert (Pegvisomant); Somavert (Pegvisomant) 10, 15 or 20mg powder and solvent for solution for injection. Dosage, Frequency : According to Japanese LPD. Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [5 years]

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician.

2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [5 years]

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician.

3. Number of Participants With Treatment-Related Adverse Events by Gender [5 years]

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

4. Number of Participants With Treatment-Related Adverse Events by Age [5 years]

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

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

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

6. Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment [5 years]

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

7. Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease) [5 years]

   A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

8. Clinical Effectiveness Rate [5 years]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.

9. Clinical Effectiveness Rate by Gender [5 years]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.

10. Clinical Effectiveness Rate by Age [5 years]

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.

11. Clinical Effectiveness Rate in Participants With Hepatic Function Disorder [5 years]

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness.

12. Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease) [5 years]

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Somavert (Pegvisomant).

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00658879
• Other Study ID Numbers: A6291023
• First Posted: Apr 15, 2008
• Last Update Posted: Jan 22, 2019
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Acromegaly

Study Results

Participant Flow

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Period Title: Overall Study
STARTED	251
COMPLETED	250
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Participants	250
Age, Customized (Number) [Number]
<15 years	2 0.8%
≥15 and <65 years	198 79.2%
≥65 years	50 20%
Sex: Female, Male (Count of Participants)
Female	141 56.4%
Male	109 43.6%
Hepatic Function Disorder (Number) [Number]
Absent	234 93.6%
Present	16 6.4%
Renal Impairment (Number) [Number]
Absent	241 96.4%
Present	9 3.6%
Diabetes Mellitus (Concurrent Disease) (Number) [Number]
Absent	139 55.6%
Present	111 44.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
Treatment-related Adverse Event	89 35.6%
Treatment-related Serious Adverse Event	20 8%

2. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
Count of Participants [Participants]	9 3.6%

3. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Gender
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
Female	52 20.8%
Male	37 14.8%

4. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Age
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
<15 years	2 0.8%
≥15 and <65 years	75 30%
≥65 years	12 4.8%

5. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
Without hepatic function disorder	85 34%
With hepatic function disorder	4 1.6%

6. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
Without renal impairment	88 35.2%
With renal impairment	1 0.4%

7. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	250
Without diabetes mellitus	57 22.8%
With diabetes mellitus	32 12.8%

8. Primary Outcome

Title	Clinical Effectiveness Rate
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	225
Number [Percentage of Participants]	96.4 38.6%

9. Primary Outcome

Title	Clinical Effectiveness Rate by Gender
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	225
Female	96.8 38.7%
Male	96.0 38.4%

10. Primary Outcome

Title	Clinical Effectiveness Rate by Age
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	225
<15 years	50.0 20%
≥15 and <65 years	96.1 38.4%
≥65 years	100.0 40%

11. Primary Outcome

Title	Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	225
Without hepatic function disorder	96.7 38.7%
With hepatic function disorder	92.3 36.9%

12. Primary Outcome

Title	Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Measure Participants	225
Without diabetes mellitus	96.0 38.4%
With diabetes mellitus	97.0 38.8%

Adverse Events

Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Arm/Group Title	Somavert (Pegvisomant)
Arm/Group Description	Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
All Cause Mortality
	Somavert (Pegvisomant)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Somavert (Pegvisomant)
	Affected / at Risk (%)	# Events
Total	39/250 (15.6%)
Cardiac disorders
Aortic valve incompetence	1/250 (0.4%)
Cardiac failure chronic	1/250 (0.4%)
Cardiac failure congestive	2/250 (0.8%)
Endocrine disorders
Hypopituitarism	1/250 (0.4%)
Gastrointestinal disorders
Abdominal pain	2/250 (0.8%)
Diverticulum intestinal haemorrhagic	1/250 (0.4%)
Intestinal obstruction	2/250 (0.8%)
Large intestine polyp	1/250 (0.4%)
Nausea	1/250 (0.4%)
Volvulus	1/250 (0.4%)
General disorders
Condition aggravated	2/250 (0.8%)
Disease progression	11/250 (4.4%)
Malaise	1/250 (0.4%)
Hepatobiliary disorders
Drug-induced liver injury	1/250 (0.4%)
Hepatic function abnormal	1/250 (0.4%)
Liver disorder	5/250 (2%)
Immune system disorders
Contrast media allergy	1/250 (0.4%)
Drug hypersensitivity	1/250 (0.4%)
Infections and infestations
Appendicitis	1/250 (0.4%)
Cholecystitis infective	1/250 (0.4%)
Pyelonephritis	1/250 (0.4%)
Pyelonephritis acute	1/250 (0.4%)
Sepsis	1/250 (0.4%)
Injury, poisoning and procedural complications
Compression fracture	1/250 (0.4%)
Fall	1/250 (0.4%)
Subdural haematoma	1/250 (0.4%)
Investigations
Platelet count decreased	1/250 (0.4%)
White blood cell count decreased	1/250 (0.4%)
Metabolism and nutrition disorders
Diabetes mellitus	1/250 (0.4%)
Hypercholesterolaemia	1/250 (0.4%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/250 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm	1/250 (0.4%)
Colon cancer	1/250 (0.4%)
Hepatic cancer metastatic	1/250 (0.4%)
Lung neoplasm malignant	1/250 (0.4%)
Metastases to lung	1/250 (0.4%)
Neoplasm progression	1/250 (0.4%)
Neoplasm skin	1/250 (0.4%)
Pancreatic carcinoma	1/250 (0.4%)
Pituitary tumour	8/250 (3.2%)
Pituitary tumour benign	4/250 (1.6%)
Pituitary tumour recurrent	3/250 (1.2%)
Nervous system disorders
Altered state of consciousness	1/250 (0.4%)
Epilepsy	1/250 (0.4%)
Hydrocephalus	1/250 (0.4%)
Loss of consciousness	1/250 (0.4%)
Seizure	1/250 (0.4%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	1/250 (0.4%)
Respiratory failure	1/250 (0.4%)
Surgical and medical procedures
Cardiac resynchronisation therapy	1/250 (0.4%)
Other (Not Including Serious) Adverse Events
	Somavert (Pegvisomant)
	Affected / at Risk (%)	# Events
Total	195/250 (78%)
Gastrointestinal disorders
Nausea	5/250 (2%)
Abdominal pain	4/250 (1.6%)
Constipation	4/250 (1.6%)
Diarrhoea	3/250 (1.2%)
General disorders
Disease progression	15/250 (6%)
Condition aggravated	4/250 (1.6%)
Injection site induration	4/250 (1.6%)
Malaise	4/250 (1.6%)
Injection site hypertrophy	3/250 (1.2%)
Injection site pruritus	3/250 (1.2%)
Hepatobiliary disorders
Hepatic function abnormal	34/250 (13.6%)
Liver disorder	10/250 (4%)
Infections and infestations
Nasopharyngitis	3/250 (1.2%)
Investigations
Blood glucose increased	6/250 (2.4%)
Gamma-glutamyltransferase increased	6/250 (2.4%)
Weight increased	5/250 (2%)
Blood growth hormone increased	4/250 (1.6%)
Alanine aminotransferase increased	3/250 (1.2%)
Aspartate aminotransferase increased	3/250 (1.2%)
Glycosylated haemoglobin increased	3/250 (1.2%)
Metabolism and nutrition disorders
Diabetes mellitus	8/250 (3.2%)
Hyperglycaemia	5/250 (2%)
Obesity	7/250 (2.8%)
Dyslipidaemia	3/250 (1.2%)
Hyperuricaemia	3/250 (1.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour	12/250 (4.8%)
Pituitary tumour recurrent	5/250 (2%)
Pituitary tumour benign	4/250 (1.6%)
Nervous system disorders
Headache	9/250 (3.6%)
Dizziness	4/250 (1.6%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	3/250 (1.2%)
Vascular disorders
Hypertension	6/250 (2.4%)

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.