Trial Outcomes & Findings for Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan (NCT NCT00658879)
NCT ID: NCT00658879
Last Updated: 2023-09-25
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
251 participants
Primary outcome timeframe
5 years
Results posted on
2023-09-25
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
251
|
|
Overall Study
COMPLETED
|
250
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
Baseline characteristics by cohort
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Age, Customized
<15 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
≥15 and <65 years
|
198 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
|
Hepatic Function Disorder
Absent
|
234 Participants
n=5 Participants
|
|
Hepatic Function Disorder
Present
|
16 Participants
n=5 Participants
|
|
Renal Impairment
Absent
|
241 Participants
n=5 Participants
|
|
Renal Impairment
Present
|
9 Participants
n=5 Participants
|
|
Diabetes Mellitus (Concurrent Disease)
Absent
|
139 Participants
n=5 Participants
|
|
Diabetes Mellitus (Concurrent Disease)
Present
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events
Treatment-related Adverse Event
|
89 Participants
|
|
Number of Participants With Treatment-Related Adverse Events
Treatment-related Serious Adverse Event
|
20 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
|
9 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Gender
Female
|
52 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Gender
Male
|
37 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Age
<15 years
|
2 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Age
≥15 and <65 years
|
75 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Age
≥65 years
|
12 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
Without hepatic function disorder
|
85 Participants
|
|
Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
With hepatic function disorder
|
4 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
Without renal impairment
|
88 Participants
|
|
Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
With renal impairment
|
1 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=250 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
Without diabetes mellitus
|
57 Participants
|
|
Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
With diabetes mellitus
|
32 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=225 Participants
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.
|
|---|---|
|
Clinical Effectiveness Rate
|
96.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=225 Participants
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.
|
|---|---|
|
Clinical Effectiveness Rate by Gender
Female
|
96.8 Percentage of Participants
|
|
Clinical Effectiveness Rate by Gender
Male
|
96.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=225 Participants
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.
|
|---|---|
|
Clinical Effectiveness Rate by Age
<15 years
|
50.0 Percentage of Participants
|
|
Clinical Effectiveness Rate by Age
≥15 and <65 years
|
96.1 Percentage of Participants
|
|
Clinical Effectiveness Rate by Age
≥65 years
|
100.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=225 Participants
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.
|
|---|---|
|
Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
Without hepatic function disorder
|
96.7 Percentage of Participants
|
|
Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
With hepatic function disorder
|
92.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Somavert (Pegvisomant)
n=225 Participants
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.
|
|---|---|
|
Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
Without diabetes mellitus
|
96.0 Percentage of Participants
|
|
Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
With diabetes mellitus
|
97.0 Percentage of Participants
|
Adverse Events
Somavert (Pegvisomant)
Serious events: 39 serious events
Other events: 117 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Somavert (Pegvisomant)
n=250 participants at risk
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.
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.40%
1/250
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.
|
|
Infections and infestations
Cholecystitis infective
|
0.40%
1/250
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.
|
|
Infections and infestations
Pyelonephritis
|
0.40%
1/250
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.40%
1/250
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.
|
|
Infections and infestations
Sepsis
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
3.2%
8/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
1.6%
4/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
1.2%
3/250
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.
|
|
Immune system disorders
Contrast media allergy
|
0.40%
1/250
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.
|
|
Immune system disorders
Drug hypersensitivity
|
0.40%
1/250
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.
|
|
Endocrine disorders
Hypopituitarism
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.40%
1/250
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.
|
|
Nervous system disorders
Altered state of consciousness
|
0.40%
1/250
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.
|
|
Nervous system disorders
Epilepsy
|
0.40%
1/250
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.
|
|
Nervous system disorders
Hydrocephalus
|
0.40%
1/250
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.
|
|
Nervous system disorders
Loss of consciousness
|
0.40%
1/250
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.
|
|
Nervous system disorders
Seizure
|
0.40%
1/250
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.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.40%
1/250
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.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.40%
1/250
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.80%
2/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
1/250
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
2/250
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.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.40%
1/250
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.80%
2/250
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.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.40%
1/250
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.
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/250
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.
|
|
Gastrointestinal disorders
Volvulus
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Liver disorder
|
2.0%
5/250
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.40%
1/250
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.
|
|
General disorders
Condition aggravated
|
0.80%
2/250
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.
|
|
General disorders
Disease progression
|
4.4%
11/250
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.
|
|
General disorders
Malaise
|
0.40%
1/250
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.
|
|
Investigations
Platelet count decreased
|
0.40%
1/250
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.
|
|
Investigations
White blood cell count decreased
|
0.40%
1/250
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.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.40%
1/250
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
1/250
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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.40%
1/250
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.
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.40%
1/250
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.
|
Other adverse events
| Measure |
Somavert (Pegvisomant)
n=250 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
1/250
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/250
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.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.40%
1/250
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.
|
|
Eye disorders
Dry eye
|
0.40%
1/250
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.
|
|
Eye disorders
Eyelid ptosis
|
0.40%
1/250
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.
|
|
Eye disorders
Iritis
|
0.40%
1/250
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.80%
2/250
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
2/250
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.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
4/250
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/250
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.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.40%
1/250
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.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
4/250
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
2/250
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.
|
|
General disorders
Chest pain
|
0.40%
1/250
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.
|
|
General disorders
Condition aggravated
|
0.80%
2/250
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.
|
|
General disorders
Disease progression
|
2.0%
5/250
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.
|
|
General disorders
Facial pain
|
0.40%
1/250
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.
|
|
General disorders
Fatigue
|
0.40%
1/250
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.
|
|
General disorders
Induration
|
0.40%
1/250
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.
|
|
General disorders
Injection site erythema
|
0.80%
2/250
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.
|
|
General disorders
Injection site hypertrophy
|
1.2%
3/250
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.
|
|
General disorders
Injection site induration
|
1.6%
4/250
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.
|
|
General disorders
Injection site pain
|
0.40%
1/250
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.
|
|
General disorders
Injection site pruritus
|
1.2%
3/250
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.
|
|
General disorders
Injection site swelling
|
0.80%
2/250
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.
|
|
General disorders
Malaise
|
1.6%
4/250
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.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.80%
2/250
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.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
13.2%
33/250
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.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.40%
1/250
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.
|
|
Hepatobiliary disorders
Liver disorder
|
2.0%
5/250
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.
|
|
Infections and infestations
Bronchitis
|
0.40%
1/250
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.
|
|
Infections and infestations
Cystitis
|
0.40%
1/250
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.
|
|
Infections and infestations
Influenza
|
0.40%
1/250
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.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
3/250
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.
|
|
Infections and infestations
Urinary tract infection
|
0.40%
1/250
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.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
3/250
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.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
3/250
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.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.40%
1/250
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.
|
|
Investigations
Blood bilirubin increased
|
0.40%
1/250
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.
|
|
Investigations
Blood glucose increased
|
2.4%
6/250
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.
|
|
Investigations
Blood growth hormone increased
|
1.6%
4/250
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.
|
|
Investigations
Blood pressure increased
|
0.80%
2/250
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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
6/250
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.
|
|
Investigations
Glycosylated haemoglobin increased
|
1.2%
3/250
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.
|
|
Investigations
Insulin-like growth factor increased
|
0.80%
2/250
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.
|
|
Investigations
Liver function test abnormal
|
0.80%
2/250
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.
|
|
Investigations
Low density lipoprotein increased
|
0.40%
1/250
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.
|
|
Investigations
Weight increased
|
2.0%
5/250
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.8%
7/250
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.2%
3/250
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.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
5/250
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.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.80%
2/250
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.
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.2%
3/250
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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.40%
1/250
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.80%
2/250
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.
|
|
Metabolism and nutrition disorders
Obesity
|
2.8%
7/250
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.80%
2/250
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.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.40%
1/250
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.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.40%
1/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
2.0%
5/250
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
0.80%
2/250
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.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.40%
1/250
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.
|
|
Nervous system disorders
Dizziness
|
1.6%
4/250
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.
|
|
Nervous system disorders
Headache
|
3.6%
9/250
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.
|
|
Nervous system disorders
Memory impairment
|
0.40%
1/250
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.
|
|
Nervous system disorders
Nervous system disorder
|
0.40%
1/250
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.
|
|
Nervous system disorders
Neuralgia
|
0.40%
1/250
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.
|
|
Renal and urinary disorders
Calculus urinary
|
0.40%
1/250
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.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.40%
1/250
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.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.40%
1/250
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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.40%
1/250
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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.40%
1/250
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.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.40%
1/250
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.2%
3/250
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.80%
2/250
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.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.80%
2/250
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.40%
1/250
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
1/250
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.40%
1/250
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.
|
|
Vascular disorders
Hypertension
|
2.4%
6/250
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER