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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somavert (Pegvisomant) | Patients taking Somavert (Pegvisomant). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somavert (Pegvisomant) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
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Inclusion Criteria:
Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered Somavert (Pegvisomant).
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The patients whom an investigator involving A6291023 prescribes Somavert (Pegvisomant).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 251 participants were enrolled in this study. Of the 251 participants, 1 participant was excluded from the baseline analysis due to protocol violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| C406545 | pegvisomant |
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|
| 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. |
| 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hepatic Function Disorder | Number | Participants |
|
| Renal Impairment | Number | Participants |
|
| Diabetes Mellitus (Concurrent Disease) | Number | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | 5 years |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | 5 years |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | 5 years |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | 5 years |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | 5 years |
|
|
|
| 39 |
| 250 |
| 117 |
| 250 |
| Cholecystitis infective | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardiac resynchronisation therapy | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Injection site hypertrophy | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood growth hormone increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
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| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
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| Diabetic neuropathy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Nervous system disorder | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Renal tubular acidosis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
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.
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ≥65 years |
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| ≥65 years |
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