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This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.
Non probability samples
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Interventional Observation | Other | Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events (SAE) and Adverse Events (AE) | Long term safety of Somavert in treatment of patients with acromegaly | Baseline up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Insulin-like Growth Factor I (IGF-I) | Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay). | Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Somavert® (active ingredient: Pegvisomant 10/15/20 mg). Dose and schedule were at discretion of each treating physician. Safety evaluations based on all 311 patients who received at least one dose of Somavert® (safety set). Results from 270 patients in the intent-to-treat (ITT) population were analyzed to evaluate the efficacy of Somavert® therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Somavert® | Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Somavert® | Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline Insulin-like Growth Factor I (IGF-I) | Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | micrograms per liter (ug/l) | Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months |
|
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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® | Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic enzyme increased | Investigations | MedDRA (v9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@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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Serum
| IGF-I Values Within Normal Range | Number of participants who have IGF-I values within normal range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| IGF-I Values Above Normal Range | Number of participants who have IGF-I values above normal range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Change From Baseline Hemoglobin A 1c (HbA 1c) | Change: HbA 1c at observation minus HbA 1c at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| HbA 1c Values Within Normal Range | Number of participants who have HbA 1c values within normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| HbA 1c Values Below Normal Range | Number of participants who have HbA 1c values below normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6) |
| HbA 1c Values Above Normal Range | Number of participants with HbA 1c values above normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Change From Baseline Glucose (Fasting) | Change: glucose at observation minus glucose at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3) |
| Glucose Values Within Normal Range (Fasting) | Number of participants who have glucose values within normal range (fasting). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose Values Below Normal Range (Fasting) | Number of participants with glucose values below normal range (fasting). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose Values Above Normal Range (Fasting) | Number of participants with glucose values above normal range (fasting). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Number of participants with glucose values (2h oGTT) within normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Number of participants with glucose values (2h oGTT) above normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| IGF-I Absolute Values | IGF-I absolute values (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Absolute Glucose Values (Fasting) | Absolute Glucose values (fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Absolute Glucose Values (2h oGTT) | Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Absolute Hemoglobin A 1c (HbA 1c) Values | Absolute value Hemoglobin A 1c (HbA 1c) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Change: HbA 1c at observation minus HbA 1c at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| HbA 1c Values Within Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Within Normal Range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| HbA 1c Values Below Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Below Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| HbA 1c Values Above Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose Change From Baseline in Diabetic Patients (Fasting) | Change: glucose at observation minus glucose at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Absolute Glucose Values in Diabetic Patients (Fasting) | Absolute Glucose Values in Patients with Diabetes (fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
| Mean Change From Baseline for Body Weight | Change: body weight at observation minus body weight at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) |
| Change From Baseline for Diastolic Blood Pressure (BP) | Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) |
| Change From Baseline for Systolic Blood Pressure (BP) | Change: systolic blood pressure at observation minus systolic blood pressure at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) |
| Change From Baseline in Ring Size | Change from baseline: ring size at observation minus ring size at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
| Other |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | IGF-I Values Within Normal Range | Number of participants who have IGF-I values within normal range (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participant | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | IGF-I Values Above Normal Range | Number of participants who have IGF-I values above normal range (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participant | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Change From Baseline Hemoglobin A 1c (HbA 1c) | Change: HbA 1c at observation minus HbA 1c at baseline. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | percent (%) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | HbA 1c Values Within Normal Range | Number of participants who have HbA 1c values within normal range. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participant | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | HbA 1c Values Below Normal Range | Number of participants who have HbA 1c values below normal range. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6) |
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| Secondary | HbA 1c Values Above Normal Range | Number of participants with HbA 1c values above normal range. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Change From Baseline Glucose (Fasting) | Change: glucose at observation minus glucose at baseline. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dl) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dl) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3) |
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| Secondary | Glucose Values Within Normal Range (Fasting) | Number of participants who have glucose values within normal range (fasting). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Glucose Values Below Normal Range (Fasting) | Number of participants with glucose values below normal range (fasting). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Glucose Values Above Normal Range (Fasting) | Number of participants with glucose values above normal range (fasting). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Number of participants with glucose values (2h oGTT) within normal range. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Number of participants with glucose values (2h oGTT) above normal range. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | IGF-I Absolute Values | IGF-I absolute values (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | micrograms per liter (ug/l) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Absolute Glucose Values (Fasting) | Absolute Glucose values (fasting) | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dl) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Absolute Glucose Values (2h oGTT) | Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dl) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Absolute Hemoglobin A 1c (HbA 1c) Values | Absolute value Hemoglobin A 1c (HbA 1c) | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | percent (%) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | 95% Confidence Interval | micrograms per liter (ug/l) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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| Secondary | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | micrograms per liter (ug/l) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
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|
|
| Secondary | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay). | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | percent (%) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Change: HbA 1c at observation minus HbA 1c at baseline. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | 95% Confidence Interval | percent (%) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | HbA 1c Values Within Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Within Normal Range. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | HbA 1c Values Below Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Below Normal Range | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participant | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | HbA 1c Values Above Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Above Normal Range | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participant | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Glucose Change From Baseline in Diabetic Patients (Fasting) | Change: glucose at observation minus glucose at baseline | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | 95% Confidence Interval | milligram per deciliter (mg/dl) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Absolute Glucose Values in Diabetic Patients (Fasting) | Absolute Glucose Values in Patients with Diabetes (fasting) | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dl) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Number | participants | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible). | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients. | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) |
|
|
|
| Secondary | Mean Change From Baseline for Body Weight | Change: body weight at observation minus body weight at baseline | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) |
|
|
|
| Secondary | Change From Baseline for Diastolic Blood Pressure (BP) | Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | millimeters per mercury (mmHg) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) |
|
|
|
| Secondary | Change From Baseline for Systolic Blood Pressure (BP) | Change: systolic blood pressure at observation minus systolic blood pressure at baseline | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | millimeters Mercury (mmHg) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) |
|
|
|
| Secondary | Change From Baseline in Ring Size | Change from baseline: ring size at observation minus ring size at baseline | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). | Posted | Mean | Standard Deviation | millimeters | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Secondary | Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. | The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set). | Posted | Number | milligram (mg) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| Primary | Serious Adverse Events (SAE) and Adverse Events (AE) | Long term safety of Somavert in treatment of patients with acromegaly | Safety Population; all patients who received at least one dose of Somavert® during the observation period. | Posted | Number | participants | Baseline up to 5 years |
|
|
|
| Secondary | Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. | Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129). | Posted | Number | milligram (mg) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) |
|
|
|
| 116 |
| 197 |
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Extragonadal primary malignant teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Metastases to abdominal wall | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Recurrent cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Respiratory tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Ureteral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Pituitary tumour removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | Non-systematic Assessment |
|
| Gallbladder operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Laparoscopic surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Pituitary gland radiotherapy | Surgical and medical procedures | Non-systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | Non-systematic Assessment |
|
| Radiotherapy to brain | Surgical and medical procedures | Non-systematic Assessment |
|
| Umbilical hernia repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
| Transaminases increased | Investigations | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
|
| Colonoscopy | Investigations | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Whiplash injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrospinal fistula | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrospinal fluid rhinorrhoea | Nervous system disorders | Non-systematic Assessment |
|
| Chiasma syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Hyposmia | Nervous system disorders | Non-systematic Assessment |
|
| Reversible ischaemic neurological deficit | Nervous system disorders | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Aortic valve sclerosis | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac death | General disorders | Non-systematic Assessment |
|
| Application site necrosis | General disorders | Non-systematic Assessment |
|
| Condition aggravated | General disorders | Non-systematic Assessment |
|
| Disease progression | General disorders | Non-systematic Assessment |
|
| No adverse event | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | Non-systematic Assessment |
|
| Peripheral circulatory failure | Vascular disorders | Non-systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | Non-systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | Non-systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Adenomatous polyposis coli | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Blindness transient | Eye disorders | Non-systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | Non-systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Transaminases increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
|
| Weight increased | Investigations | Non-systematic Assessment |
|
| Analgesic drug level increased | Investigations | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | Non-systematic Assessment |
|
| Colonoscopy | Investigations | Non-systematic Assessment |
|
| Waist circumference increased | Investigations | Non-systematic Assessment |
|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Benign colonic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Extragonadal primary malignant teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Metastases to abdominal wall | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Recurrent cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Respiratory tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Ureteral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Pituitary tumour removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | Non-systematic Assessment |
|
| Radiotherapy to brain | Surgical and medical procedures | Non-systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | Non-systematic Assessment |
|
| Gallbladder operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastrectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Hypophysectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Laparoscopic surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Pituitary gland radiotherapy | Surgical and medical procedures | Non-systematic Assessment |
|
| Polypectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Therapy regimen changed | Surgical and medical procedures | Non-systematic Assessment |
|
| Umbilical hernia repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Fat tissue increased | General disorders | Non-systematic Assessment |
|
| Injection site erythema | General disorders | Non-systematic Assessment |
|
| Disease progression | General disorders | Non-systematic Assessment |
|
| Cardiac death | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Injection site hypertrophy | General disorders | Non-systematic Assessment |
|
| Injection site reaction | General disorders | Non-systematic Assessment |
|
| Injection site swelling | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | Non-systematic Assessment |
|
| Application site necrosis | General disorders | Non-systematic Assessment |
|
| Condition aggravated | General disorders | Non-systematic Assessment |
|
| Drug ineffective | General disorders | Non-systematic Assessment |
|
| Facial pain | General disorders | Non-systematic Assessment |
|
| Feeling cold | General disorders | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Injection site induration | General disorders | Non-systematic Assessment |
|
| Injection site oedema | General disorders | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | Non-systematic Assessment |
|
| No adverse event | General disorders | Non-systematic Assessment |
|
| Ulcer | General disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Hyposmia | Nervous system disorders | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrospinal fistula | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrospinal fluid rhinorrhoea | Nervous system disorders | Non-systematic Assessment |
|
| Chiasma syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| IIIrd nerve paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Reversible ischaemic neurological deficit | Nervous system disorders | Non-systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
|
| Visual field defect | Nervous system disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric cyst | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | Non-systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | Non-systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | Non-systematic Assessment |
|
| Gonadotrophin deficiency | Endocrine disorders | Non-systematic Assessment |
|
| Hypogonadism | Endocrine disorders | Non-systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | Non-systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | Non-systematic Assessment |
|
| Hyperparathyroidism primary | Endocrine disorders | Non-systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Pituitary haemorrhage | Endocrine disorders | Non-systematic Assessment |
|
| Secondary hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | Non-systematic Assessment |
|
| Macroangiopathy | Vascular disorders | Non-systematic Assessment |
|
| Peripheral circulatory failure | Vascular disorders | Non-systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nodal osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Lactose intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Infection | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Dermatophytosis | Infections and infestations | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Aortic valve sclerosis | Cardiac disorders | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Radiation associated pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Whiplash injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lipohypertrophy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hyperhidrosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bronchial irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Loss of libido | Psychiatric disorders | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Prostatism | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Non-systematic Assessment |
|
| Blindness transient | Eye disorders | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | Non-systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | Non-systematic Assessment |
|
| Adenomatous polyposis coli | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal arteriosclerosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal atrophy | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | Non-systematic Assessment |
|
| House dust allergy | Immune system disorders | Non-systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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 |
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=147) |
|
| Follow-up 4 (n=79) |
|
| Follow-up 5 (n=21) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=147) |
|
| Follow-up 4 (n=79) |
|
| Follow-up 5 (n=21) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=41) |
|
| Follow-up 5 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=82) |
|
| Follow-up 4 (n=43) |
|
| Follow-up 5 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=82) |
|
| Follow-up 4 (n=43) |
|
| Follow-up 5 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=82) |
|
| Follow-up 4 (n=43) |
|
| Follow-up 5 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=33) |
|
| Follow-up 5 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=78) |
|
| Follow-up 4 (n=35) |
|
| Follow-up 5 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=78) |
|
| Follow-up 4 (n=35) |
|
| Follow-up 5 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=78) |
|
| Follow-up 4 (n=35) |
|
| Follow-up 5 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=3) |
|
| Follow-up 4 (n=0) |
|
| Follow-up 5 (n=0) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=3) |
|
| Follow-up 4 (n=0) |
|
| Follow-up 5 (n=0) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=131) |
|
| Follow-up 4 (n=71) |
|
| Follow-up 5 (n=18) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=70) |
|
| Follow-up 4 (n=33) |
|
| Follow-up 5 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=2) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=80) |
|
| Follow-up 4 (n=41) |
|
| Follow-up 5 (n=10) |
|
|
| Follow-up 4 (n=24) |
|
| Follow-up 5 (n=4) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=44) |
|
| Follow-up 4 (n=24) |
|
| Follow-up 5 (n=4) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=49) |
|
| Follow-up 4 (n=26) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=49) |
|
| Follow-up 4 (n=26) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=36) |
|
| Follow-up 4 (n=21) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=21) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=38) |
|
| Follow-up 4 (n=22) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=38) |
|
| Follow-up 4 (n=22) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=38) |
|
| Follow-up 4 (n=22) |
|
| Follow-up 5 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=13) |
|
| Follow-up 5 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=21) |
|
| Follow-up 4 (n=13) |
|
| Follow-up 5 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=25) |
|
| Follow-up 4 (n=14) |
|
| Follow-up 5 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 3 (n=25) |
|
| Follow-up 4 (n=14) |
|
| Follow-up 5 (n=3) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=14) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=61) |
|
| Follow-up 5 (n=13) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=64) |
|
| Follow-up 5 (n=15) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=65) |
|
| Follow-up 5 (n=15) |
|
| Title | Measurements |
|---|---|
|
| Follow-up 4 (n=16) |
|
| Follow-up 5 (n=2) |
|