Acromegaly
Conditions
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.
Interventions
DRUGSomavert (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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Somavert (Pegvisomant) 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. | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Somavert (Pegvisomant) |
|---|---|
| Age, Customized ≥15 and <65 years | 198 Participants |
| Age, Customized <15 years | 2 Participants |
| Age, Customized ≥65 years | 50 Participants |
| Diabetes Mellitus (Concurrent Disease) Absent | 139 Participants |
| Diabetes Mellitus (Concurrent Disease) Present | 111 Participants |
| Hepatic Function Disorder Absent | 234 Participants |
| Hepatic Function Disorder Present | 16 Participants |
| Renal Impairment Absent | 241 Participants |
| Renal Impairment Present | 9 Participants |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 117 / 250 |
| serious Total, serious adverse events | 39 / 250 |
Outcome results
Primary
Clinical Effectiveness Rate
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Somavert (Pegvisomant) | Clinical Effectiveness Rate | 96.4 Percentage of Participants |
Primary
Clinical Effectiveness Rate by Age
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert (Pegvisomant) | Clinical Effectiveness Rate by Age | <15 years | 50.0 Percentage of Participants |
| Somavert (Pegvisomant) | Clinical Effectiveness Rate by Age | ≥15 and <65 years | 96.1 Percentage of Participants |
| Somavert (Pegvisomant) | Clinical Effectiveness Rate by Age | ≥65 years | 100.0 Percentage of Participants |
Primary
Clinical Effectiveness Rate by Gender
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert (Pegvisomant) | Clinical Effectiveness Rate by Gender | Female | 96.8 Percentage of Participants |
| Somavert (Pegvisomant) | Clinical Effectiveness Rate by Gender | Male | 96.0 Percentage of Participants |
Primary
Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert (Pegvisomant) | Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease) | Without diabetes mellitus | 96.0 Percentage of Participants |
| Somavert (Pegvisomant) | Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease) | With diabetes mellitus | 97.0 Percentage of Participants |
Primary
Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert (Pegvisomant) | Clinical Effectiveness Rate in Participants With Hepatic Function Disorder | With hepatic function disorder | 92.3 Percentage of Participants |
| Somavert (Pegvisomant) | Clinical Effectiveness Rate in Participants With Hepatic Function Disorder | Without hepatic function disorder | 96.7 Percentage of Participants |
Primary
Number of Participants With Treatment-Related Adverse Events
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events | Treatment-related Adverse Event | 89 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events | Treatment-related Serious Adverse Event | 20 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events by Age
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events by Age | ≥15 and <65 years | 75 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events by Age | ≥65 years | 12 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events by Age | <15 years | 2 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events by Gender
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events by Gender | Female | 52 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events by Gender | Male | 37 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease) | Without diabetes mellitus | 57 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease) | With diabetes mellitus | 32 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder | Without hepatic function disorder | 85 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder | With hepatic function disorder | 4 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment | Without renal impairment | 88 Participants |
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment | With renal impairment | 1 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Somavert (Pegvisomant) | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 9 Participants |