## Protocol Section
### Identification Module
**NCT ID:** NCT00658879

**Brief Title:** Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan

**Official Title:** SPECIAL INVESTIGATION OF SOMAVERT -LONG TERM USE-

#### Organization Study ID Info
**ID:** A6291023
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2016-11-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-25

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-11-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-01-22

**Type:** ACTUAL

**Results First Submit Date:** 2017-09-26

**Results First Submit QC Date:** 2018-08-09

#### Start Date
**Date:** 2007-08-07

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2008-04-15
**Type:** ESTIMATED
**Study First Submit Date:** 2008-04-09
**Study First Submit QC Date:** 2008-04-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

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

### Conditions Module

**Conditions:**

- Acromegaly

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 251

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients taking Somavert (Pegvisomant).

**Intervention Names:**

- Drug: Somavert (Pegvisomant)

**Label:** Somavert (Pegvisomant)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Somavert (Pegvisomant)

**Description:** 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.

**Name:** Somavert (Pegvisomant)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events

**Time Frame:** 5 years

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

**Time Frame:** 5 years

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events by Gender

**Time Frame:** 5 years

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events by Age

**Time Frame:** 5 years

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder

**Time Frame:** 5 years

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment

**Time Frame:** 5 years

**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.

**Measure:** Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)

**Time Frame:** 5 years

**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.

**Measure:** Clinical Effectiveness Rate

**Time Frame:** 5 years

**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.

**Measure:** Clinical Effectiveness Rate by Gender

**Time Frame:** 5 years

**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.

**Measure:** Clinical Effectiveness Rate by Age

**Time Frame:** 5 years

**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.

**Measure:** Clinical Effectiveness Rate in Participants With Hepatic Function Disorder

**Time Frame:** 5 years

**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.

**Measure:** Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Somavert (Pegvisomant).

**Minimum Age:** 0 Days

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** The patients whom an investigator involving A6291023 prescribes Somavert (Pegvisomant).

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6291023&StudyName=Long%20Term%20Use%20of%20Pegvisomant%20For%20A%20Regulatory%20Post%20Marketing%20Commitment%20Plan%20

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001849

- Term: Bone Diseases, Endocrine

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000006964

- Term: Hyperpituitarism

- ID: D000010900

- Term: Pituitary Diseases

- ID: D000007027

- Term: Hypothalamic Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3531

- Name: Acromegaly

- Relevance: HIGH

- As Found: Acromegaly

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5128

- Name: Bone Diseases, Endocrine

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13791

- Name: Pituitary Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10077

- Name: Hypothalamic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T139

- Name: Acromegaly

- Relevance: HIGH

- As Found: Acromegaly

### Condition Browse Module - Meshes

- ID: D000000172

- Term: Acromegaly

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**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.

#### Event Groups

**Group ID:** EG000

**Title:** Somavert (Pegvisomant)

**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.

**ID:** EG000

**Other Num Affected:** 117

**Other Num at Risk:** 250

**Serious Number Affected:** 39

**Serious Number At Risk:** 250

**Title:** Somavert (Pegvisomant)

**Frequency Threshold:** 0

#### Other Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Atrial fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Deafness unilateral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Dry eye

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Eyelid ptosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Iritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Abdominal distension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Large intestine polyp

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Condition aggravated

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Disease progression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Facial pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Induration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Injection site erythema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Injection site hypertrophy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Injection site induration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Injection site pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Injection site pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Injection site swelling

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Malaise

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Alcoholic liver disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Cholangitis acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Cholelithiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hepatic function abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hepatic steatosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hyperbilirubinaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Liver disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Bronchitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Cystitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Nasopharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Alanine aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Blood bilirubin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Blood glucose increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Blood growth hormone increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Blood pressure increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Glycosylated haemoglobin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Insulin-like growth factor increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Liver function test abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Low density lipoprotein increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Weight increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Decreased appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Diabetes mellitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Diabetes mellitus inadequate control

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Dyslipidaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Glucose tolerance impaired

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hyperglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hyperlipidaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hyperphosphatasaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hyperuricaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hypocalcaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hypoglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Obesity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Joint lock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Rheumatoid arthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Pituitary tumour

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

**Term:** Pituitary tumour recurrent

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

**Term:** Diabetic neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Memory impairment

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Nervous system disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Neuralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Calculus urinary

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Renal tubular acidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Ureteric stenosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Benign prostatic hyperplasia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Dysmenorrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Endometriosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Asthma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hyperventilation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Productive cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Rhinalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Rhinitis allergic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Sleep apnoea syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Upper respiratory tract inflammation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Alopecia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Dermal cyst

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Urticaria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 19.0

#### Serious Events

**Term:** Appendicitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Cholecystitis infective

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Pyelonephritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Pyelonephritis acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Brain neoplasm

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Colon cancer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Hepatic cancer metastatic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Lung neoplasm malignant

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Metastases to lung

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Neoplasm progression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Neoplasm skin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Pancreatic carcinoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Pituitary tumour

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 250

**Term:** Pituitary tumour benign

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 250

**Term:** Pituitary tumour recurrent

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 250

**Term:** Contrast media allergy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Drug hypersensitivity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Hypopituitarism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Diabetes mellitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Hypercholesterolaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Altered state of consciousness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Epilepsy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Hydrocephalus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Loss of consciousness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Seizure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Aortic valve incompetence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Cardiac failure chronic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Cardiac failure congestive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 250

**Term:** Pneumonia aspiration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 250

**Term:** Diverticulum intestinal haemorrhagic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Intestinal obstruction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 250

**Term:** Large intestine polyp

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Volvulus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Drug-induced liver injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Hepatic function abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Liver disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 250

**Term:** Osteoarthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Condition aggravated

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 250

**Term:** Disease progression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 250

**Term:** Malaise

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Platelet count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** White blood cell count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Compression fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Subdural haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

**Term:** Cardiac resynchronisation therapy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 250

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 250

**Units:** Participants

### Group

**ID:** BG000

**Title:** Somavert (Pegvisomant)

**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

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** <15 years

#### Measurement

**Group ID:** BG000

**Value:** 198

**Class Title:** ≥15 and <65 years

#### Measurement

**Group ID:** BG000

**Value:** 50

**Class Title:** ≥65 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 141

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 109

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 234

**Class Title:** Absent

#### Measurement

**Group ID:** BG000

**Value:** 16

**Class Title:** Present

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 241

**Class Title:** Absent

#### Measurement

**Group ID:** BG000

**Value:** 9

**Class Title:** Present

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 139

**Class Title:** Absent

#### Measurement

**Group ID:** BG000

**Value:** 111

**Class Title:** Present

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Hepatic Function Disorder
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Renal Impairment
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Diabetes Mellitus (Concurrent Disease)
**Unit of Measure:** Participants
**Population Description:** A total of 251 participants were enrolled in this study. Of the 251 participants, 1 participant was excluded from the baseline analysis due to protocol violation.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrials.gov_Inquiries@pfizer.com
**Organization:** Pfizer, Inc.
**Phone:** 1-800-718-1021
**Title:** Pfizer ClinicalTrials.gov Call Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 52
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 141
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 109
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 2
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 198
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 50
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 234
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 16
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 241
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 9
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 139
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 111
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.4
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 126
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 99
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 2
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 180
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 43
**Units:** Participants
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 212
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 92.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
**Units:** Participants
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 126
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 99
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 2
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 3
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events by Gender
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 4
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events by Age
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 5
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 6
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 7
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 8
**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.
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Clinical Effectiveness Rate
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 9
**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.
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Clinical Effectiveness Rate by Gender
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 10
**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.
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Clinical Effectiveness Rate by Age
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 11
**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.
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
#### Outcome Measure 12
**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.
**Parameter Type:** NUMBER
**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.
**Reporting Status:** POSTED
**Time Frame:** 5 years
**Title:** Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### 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.
**ID:** OG000
**Title:** Somavert (Pegvisomant)
### Participant Flow Module
#### 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.
**ID:** FG000
**Title:** Somavert (Pegvisomant)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 251
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 250
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Has Results:** True