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| ID | Type | Description | Link |
|---|---|---|---|
| SWEGHO | Other Identifier | Alias Study Number |
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The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment.
This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.
Patients within inclusion criteria are asked to participate in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Growth Hormone deficient Patients | Patients with GHD on Genotropin® replacement therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Interventional Study | Other | Non Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; >80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age. | Up to 5 years (after baseline visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received Genotropin without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. |
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Inclusion Criteria:
Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;
Prescribed Genotropin at the time of inclusion.
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
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Patients wiht Growth Hormone Deficiency
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vastra Gotalands Regionen | Skövde | Skaraborg | 541 85 | Sweden | ||
| Landstinget Dalarna |
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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 | KIMS Adult Onset Growth Hormone Deficiency (GHD) | Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2015 | Oct 29, 2019 |
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| Baseline up to 5 years |
| Number of Treatment Related Adverse Events | Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. If there was any relationship between AE and Genotropin treatment,that was judged by investigator. | Baseline up to 5 years |
| Number of Adverse Events Leading to Withdrawal of Genotropin Treatment | An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. | Baseline up to 5 years |
| Number of Participants Who Discontinued Study Due to Adverse Events | An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. Participants who discontinued study due to AEs were reported. | Baseline up to 5 years |
| Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Weight of participants was measured in kilograms (kg). | Baseline, Year 1, 2, 3, 4, 5 |
| Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Weight of participants was measured in kg. | Baseline, Year 1, 2, 3, 4, 5 |
| Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Height of participants was measured in centimeters. | Baseline, Year 1, 2, 3, 4, 5 |
| Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Height of participants was measured in centimeters. | Baseline, Year 1, 2, 3, 4, 5 |
| Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2). | Baseline, Year 1, 2, 3, 4, 5 |
| Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in m^2. | Baseline, Year 1, 2, 3, 4, 5 |
| Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP). | Baseline, Year 1, 2, 3, 4, 5 |
| Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Measurement of BP included supine SBP and DBP. | Baseline, Year 1, 2, 3, 4, 5 |
| Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Heart rate was measured in supine position. | Baseline, Year 1, 2, 3, 4, 5 |
| Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Heart rate was measured in supine position. | Baseline, Year 1, 2, 3, 4, 5 |
| Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Body composition included parameters fat mass and muscle mass. | Baseline, Year 1, 2, 3, 4 |
| Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels. MRI investigation uses strong magnetic field and radio waves to create detailed images of the organs and tissues within the body. | Baseline, Year 1, 2, 3, 4, 5 |
| Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Hormones that were evaluated were thyroid stimulating hormone, adrenocorticotropic hormone, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone and prolactin hormone. Abnormalities were judged by the investigator. | Baseline, Year 1, 2, 3, 4 |
| Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported. | Baseline, Follow-up (during 28 days after last dose of Genotropin treatment) |
| Falun |
| 791 82 |
| Sweden |
| Sahlgrenska University hospital | Gothenburg | 413 45 | Sweden |
| Central Hospital/ Department of Medicine | Kristianstad | 291 85 | Sweden |
| Universitetssjukhuset, EM-kliniken | Linköping | 581 85 | Sweden |
| Ljungby Lasarettet | Ljungby | 341 82 | Sweden |
| University Hospital SUS | Malmö | 205 02 | Sweden |
| Landstinget i Stockholms Lan | Stockholm | 118 83 | Sweden |
| Karolinska Universitetssjukhuset, Kliniken for Endokrinologi | Stockholm | 171 76 | Sweden |
| Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen | Uppsala | 751 85 | Sweden |
| Medicinkliniken, Centrallasarettet Vaxjo | Vaxjo | 351 85 | Sweden |
| Landstinget i Jonkopings Lan | Värnamo | 331 85 | Sweden |
| FG001 | Naive Adult Onset GHD | Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| FG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | KIMS Adult Onset Growth Hormone Deficiency (GHD) | Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012. |
| BG001 | Naive Adult Onset GHD | Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| BG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; >80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age. | Full analysis set (FAS) included all correctly enrolled participants who received at least 1 dose of Genotropin. Erroneously enrolled participants were excluded from FAS, as they did not meet the inclusion criteria or met an exclusion criterion, which was discovered after enrolment to the study. | Posted | Count of Participants | Participants | Up to 5 years (after baseline visit) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received Genotropin without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. | Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. | Posted | Count of Participants | Participants | Baseline up to 5 years |
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| Secondary | Number of Treatment Related Adverse Events | Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. If there was any relationship between AE and Genotropin treatment,that was judged by investigator. | Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. | Posted | Number | adverse events | Baseline up to 5 years |
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| Secondary | Number of Adverse Events Leading to Withdrawal of Genotropin Treatment | An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. | Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. | Posted | Number | adverse events | Baseline up to 5 years |
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| Secondary | Number of Participants Who Discontinued Study Due to Adverse Events | An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. Participants who discontinued study due to AEs were reported. | Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. | Posted | Count of Participants | Participants | Baseline up to 5 years |
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| Secondary | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Weight of participants was measured in kilograms (kg). | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | kg | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Weight of participants was measured in kg. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | kg | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Height of participants was measured in centimeters. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Height of participants was measured in centimeters. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2). | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | Kilogram per meter squared (kg/m^2) | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in m^2. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP). | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Measurement of BP included supine SBP and DBP. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Heart rate was measured in supine position. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Heart rate was measured in supine position. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | bpm | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Body composition included parameters fat mass and muscle mass. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | percentage of participants | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels. MRI investigation uses strong magnetic field and radio waves to create detailed images of the organs and tissues within the body. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | percentage of participants | Baseline, Year 1, 2, 3, 4, 5 |
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| Secondary | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Hormones that were evaluated were thyroid stimulating hormone, adrenocorticotropic hormone, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone and prolactin hormone. Abnormalities were judged by the investigator. | FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | percentage of participants | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported. | All participants who were enrolled in the study. | Posted | Number | percentage of participants | Baseline, Follow-up (during 28 days after last dose of Genotropin treatment) |
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Baseline up to 28 days after last dose of Genotropin treatment (maximum up to 5 years)
Same event may appear as an AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Participants treated with at least 1 dose of Genotropin were evaluated for safety.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KIMS Adult Onset Growth Hormone Deficiency (GHD) | Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012. | 12 | 246 | 57 | 246 | 66 | 246 |
| EG001 | Naive Adult Onset GHD | Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. | 1 | 41 | 5 | 41 | 14 | 41 |
| EG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. | 0 | 87 | 10 | 87 | 15 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pituitary tumour recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Guillain-barre syndrome | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cortisol deficiency | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperparat hyroidism | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pituitary apoplexy | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dysplasia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Strangulated incisional hernia | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neurofibromatosis | Congenital, familial and genetic disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Amputation | Surgical and medical procedures | MedDRA 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Upper respiratory track infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Colonoscopy | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood prolactin increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood testosterone increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood homocysteine increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood folate decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperparat hyroidism primary | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastric banding | Surgical and medical procedures | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Non-systematic Assessment |
| |
| Syringe issue | Product Issues | MedDRA 22.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2019 | Oct 29, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
|
|
|
| IGF-I ULN within reference range |
|
| IGF-I Unknown |
|
| OG001 | Naive Adult Onset GHD | Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| Naive Adult Onset GHD |
Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| Naive Adult Onset GHD |
Participants who were newly diagnosed with GHD as per current medical standards, aged >=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) |
Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|
| OG002 | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Participants were diagnosed with CO-GHD before 2013. Participants aged >=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. |
|
|