Growth Hormone Deficiency
Conditions
Brief summary
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.
Detailed description
Patients within inclusion criteria are asked to participate in the study.
Interventions
OTHERNon Interventional Study
Non Interventional Study
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below; 1. Newly diagnosed with GHD according to the current medical standard. 2. Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®. 3. Transition patients diagnosed with CO-GHD before 2013. * 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
* Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | Up to 5 years (after baseline visit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Related Adverse Events | Baseline up to 5 years | 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. |
| Number of Adverse Events Leading to Withdrawal of Genotropin Treatment | Baseline up to 5 years | 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. |
| Number of Participants Who Discontinued Study Due to Adverse Events | Baseline up to 5 years | 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. |
| Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Weight of participants was measured in kilograms (kg). |
| Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Weight of participants was measured in kg. |
| Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Height of participants was measured in centimeters. |
| Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Height of participants was measured in centimeters. |
| Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 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). |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 5 years | 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. |
| Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP). |
| Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Measurement of BP included supine SBP and DBP. |
| Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Heart rate was measured in supine position. |
| Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 5 | Heart rate was measured in supine position. |
| Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Baseline, Year 1, 2, 3, 4 | Body composition included parameters fat mass and muscle mass. |
| Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 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. |
| Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Baseline, Year 1, 2, 3, 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. |
| Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | Baseline, Follow-up (during 28 days after last dose of Genotropin treatment) | Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported. |
| Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Baseline, Year 1, 2, 3, 4, 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 247 |
| 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. | 42 |
| 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. | 88 |
| Total | 377 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 0 |
| Overall Study | Death | 12 | 1 | 0 |
| Overall Study | Other | 3 | 4 | 3 |
| Overall Study | Physician Decision | 2 | 0 | 0 |
| Overall Study | Switched to other growth hormone brand | 53 | 8 | 23 |
| Overall Study | Withdrawal by Subject | 12 | 4 | 1 |
Baseline characteristics
| Characteristic | KIMS Adult Onset Growth Hormone Deficiency (GHD) | Naive Adult Onset GHD | Childhood Onset Growth Hormone Deficiency (CO-GHD) | Total |
|---|---|---|---|---|
| Age, Customized 0 to less than or equal to (<=) 18 Years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 Years | 100 Participants | 4 Participants | 2 Participants | 106 Participants |
| Age, Customized Greater than (>) 18 to less than (<) 65 Years | 138 Participants | 38 Participants | 83 Participants | 259 Participants |
| Age, Customized Unknown | 9 Participants | 0 Participants | 3 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 120 Participants | 22 Participants | 42 Participants | 184 Participants |
| Sex: Female, Male Male | 127 Participants | 20 Participants | 46 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 246 | 1 / 41 | 0 / 87 |
| other Total, other adverse events | 66 / 246 | 14 / 41 | 15 / 87 |
| serious Total, serious adverse events | 57 / 246 | 5 / 41 | 10 / 87 |
Outcome results
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.
Time frame: Up to 5 years (after baseline visit)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I ULN | 63 Participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I LLN | 11 Participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I Unknown | 13 Participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I ULN within reference range | 159 Participants |
| Naive Adult Onset GHD | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I LLN | 2 Participants |
| Naive Adult Onset GHD | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I Unknown | 6 Participants |
| Naive Adult Onset GHD | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I ULN within reference range | 22 Participants |
| Naive Adult Onset GHD | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I ULN | 8 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I Unknown | 6 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I ULN within reference range | 47 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I ULN | 30 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments | IGF-I LLN | 4 Participants |
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).
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Baseline | 132.3 millimeter of mercury (mmHg) | Standard Deviation 16.47 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 1 | 132.7 millimeter of mercury (mmHg) | Standard Deviation 17.82 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 2 | 133.3 millimeter of mercury (mmHg) | Standard Deviation 16.82 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 3 | 133.4 millimeter of mercury (mmHg) | Standard Deviation 15.68 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 4 | 132.3 millimeter of mercury (mmHg) | Standard Deviation 14.8 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 5 | 137.4 millimeter of mercury (mmHg) | Standard Deviation 17.76 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Baseline | 78.4 millimeter of mercury (mmHg) | Standard Deviation 9.32 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 1 | 77.1 millimeter of mercury (mmHg) | Standard Deviation 9.37 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 2 | 78.2 millimeter of mercury (mmHg) | Standard Deviation 9.1 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 3 | 79.0 millimeter of mercury (mmHg) | Standard Deviation 9.04 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 4 | 77.5 millimeter of mercury (mmHg) | Standard Deviation 9.01 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 5 | 80.6 millimeter of mercury (mmHg) | Standard Deviation 12.82 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 4 | 134.4 millimeter of mercury (mmHg) | Standard Deviation 14.01 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 4 | 80.6 millimeter of mercury (mmHg) | Standard Deviation 11.91 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 1 | 127.4 millimeter of mercury (mmHg) | Standard Deviation 16 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 3 | 77.2 millimeter of mercury (mmHg) | Standard Deviation 10.99 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 2 | 75.8 millimeter of mercury (mmHg) | Standard Deviation 12.32 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 2 | 133.5 millimeter of mercury (mmHg) | Standard Deviation 21.97 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 1 | 73.0 millimeter of mercury (mmHg) | Standard Deviation 11 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Baseline | 75.5 millimeter of mercury (mmHg) | Standard Deviation 10.76 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 3 | 130.4 millimeter of mercury (mmHg) | Standard Deviation 20.13 |
| Naive Adult Onset GHD | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Baseline | 123.6 millimeter of mercury (mmHg) | Standard Deviation 13.47 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 2 | 76.3 millimeter of mercury (mmHg) | Standard Deviation 9.06 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 4 | 76.1 millimeter of mercury (mmHg) | Standard Deviation 8.04 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 3 | 123.4 millimeter of mercury (mmHg) | Standard Deviation 14.26 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 4 | 127.8 millimeter of mercury (mmHg) | Standard Deviation 13.97 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 5 | 121.0 millimeter of mercury (mmHg) | Standard Deviation 1.41 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 3 | 76.0 millimeter of mercury (mmHg) | Standard Deviation 7.84 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Baseline | 74.0 millimeter of mercury (mmHg) | Standard Deviation 8.29 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 5 | 70.5 millimeter of mercury (mmHg) | Standard Deviation 0.71 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine DBP- Year 1 | 74.6 millimeter of mercury (mmHg) | Standard Deviation 9.01 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Baseline | 120.3 millimeter of mercury (mmHg) | Standard Deviation 13.4 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 1 | 122.9 millimeter of mercury (mmHg) | Standard Deviation 11.74 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Supine SBP- Year 2 | 124.1 millimeter of mercury (mmHg) | Standard Deviation 14.37 |
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).
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 27.9 Kilogram per meter squared (kg/m^2) | Standard Deviation 4.2 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 27.4 Kilogram per meter squared (kg/m^2) | Standard Deviation 4.09 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 28.2 Kilogram per meter squared (kg/m^2) | Standard Deviation 5.45 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 28.8 Kilogram per meter squared (kg/m^2) | Standard Deviation 5.55 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 27.8 Kilogram per meter squared (kg/m^2) | Standard Deviation 6.14 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 28.3 Kilogram per meter squared (kg/m^2) | Standard Deviation 4.76 |
| Naive Adult Onset GHD | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 28.5 Kilogram per meter squared (kg/m^2) | Standard Deviation 4.7 |
| Naive Adult Onset GHD | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 33.2 Kilogram per meter squared (kg/m^2) | Standard Deviation 2.92 |
| Naive Adult Onset GHD | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 27.8 Kilogram per meter squared (kg/m^2) | Standard Deviation 5.71 |
| Naive Adult Onset GHD | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 28.9 Kilogram per meter squared (kg/m^2) | Standard Deviation 4.7 |
| Naive Adult Onset GHD | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 28.3 Kilogram per meter squared (kg/m^2) | Standard Deviation 5.56 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 36.6 Kilogram per meter squared (kg/m^2) | Standard Deviation 2.81 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 29.6 Kilogram per meter squared (kg/m^2) | Standard Deviation 8.42 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 28.9 Kilogram per meter squared (kg/m^2) | Standard Deviation 7.26 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 29.8 Kilogram per meter squared (kg/m^2) | Standard Deviation 6.08 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 29.8 Kilogram per meter squared (kg/m^2) | Standard Deviation 6.47 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 28.2 Kilogram per meter squared (kg/m^2) | Standard Deviation 7.24 |
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.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 1 | 1.0 mmHg | Standard Deviation 15.67 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 2 | 0.4 mmHg | Standard Deviation 15.78 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 3 | 1.0 mmHg | Standard Deviation 13.84 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 4 | -1.5 mmHg | Standard Deviation 19.91 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 5 | 5.7 mmHg | Standard Deviation 19.26 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 1 | -1.2 mmHg | Standard Deviation 10.66 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 2 | -0.6 mmHg | Standard Deviation 10.84 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 3 | 0.7 mmHg | Standard Deviation 10.44 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 4 | -1.5 mmHg | Standard Deviation 12.07 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 5 | 3.0 mmHg | Standard Deviation 12.36 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 3 | -0.4 mmHg | Standard Deviation 8.2 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 1 | -4.2 mmHg | Standard Deviation 10.2 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 4 | -2.8 mmHg | Standard Deviation 9.77 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 2 | 0.5 mmHg | Standard Deviation 11.81 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 1 | -0.9 mmHg | Standard Deviation 11.52 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 2 | 6.1 mmHg | Standard Deviation 17.48 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 3 | 1.5 mmHg | Standard Deviation 17.11 |
| Naive Adult Onset GHD | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 4 | 10.5 mmHg | Standard Deviation 10.65 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 2 | 2.3 mmHg | Standard Deviation 12.81 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 4 | 2.0 mmHg | Standard Deviation 9.5 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 1 | 3.4 mmHg | Standard Deviation 13.52 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 4 | 4.3 mmHg | Standard Deviation 16.4 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 3 | 0.8 mmHg | Standard Deviation 8.81 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 5 | -4.0 mmHg | Standard Deviation 8.49 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 5 | 0.5 mmHg | Standard Deviation 0.71 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 2 | 1.8 mmHg | Standard Deviation 8.17 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine DBP- Year 1 | 0.6 mmHg | Standard Deviation 9.83 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 | Change in Supine SBP- Year 3 | 4.3 mmHg | Standard Deviation 12.41 |
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.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | -0.4 kg/m^2 | Standard Deviation 2.62 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 0.7 kg/m^2 | Standard Deviation 3.75 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | 0 kg/m^2 | Standard Deviation 2.67 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | -0.7 kg/m^2 | Standard Deviation 2.85 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | -0.2 kg/m^2 | Standard Deviation 2.25 |
| Naive Adult Onset GHD | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | -0.5 kg/m^2 | Standard Deviation 3.84 |
| Naive Adult Onset GHD | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | -0.4 kg/m^2 | Standard Deviation 4.6 |
| Naive Adult Onset GHD | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | -0.3 kg/m^2 | Standard Deviation 4.13 |
| Naive Adult Onset GHD | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 1.8 kg/m^2 | Standard Deviation 2.43 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 0.3 kg/m^2 | Standard Deviation 2.03 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | -4.3 kg/m^2 | Standard Deviation 6.78 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | -0.1 kg/m^2 | Standard Deviation 2.54 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | -0.9 kg/m^2 | Standard Deviation 7.79 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | -1.1 kg/m^2 | Standard Deviation 6.02 |
Secondary
Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5
Heart rate was measured in supine position.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 1.3 bpm | Standard Deviation 8.97 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 0.1 bpm | Standard Deviation 13.24 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | 1.4 bpm | Standard Deviation 11.62 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 0.7 bpm | Standard Deviation 10.57 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | 3.7 bpm | Standard Deviation 13.49 |
| Naive Adult Onset GHD | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 1.5 bpm | Standard Deviation 13.94 |
| Naive Adult Onset GHD | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | -1.4 bpm | Standard Deviation 12.66 |
| Naive Adult Onset GHD | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 1.8 bpm | Standard Deviation 14.88 |
| Naive Adult Onset GHD | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 1.0 bpm | Standard Deviation 16.31 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 3.4 bpm | Standard Deviation 11.47 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | 0 bpm | — |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 0.7 bpm | Standard Deviation 9.76 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | 4.7 bpm | Standard Deviation 12.06 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 1.6 bpm | Standard Deviation 15.11 |
Secondary
Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5
Height of participants was measured in centimeters.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 0 centimeters (cm) | Standard Deviation 0.56 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 0 centimeters (cm) | Standard Deviation 0.6 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | 0 centimeters (cm) | Standard Deviation 0.31 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 0 centimeters (cm) | Standard Deviation 0.3 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | -0.1 centimeters (cm) | Standard Deviation 0.52 |
| Naive Adult Onset GHD | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 0 centimeters (cm) | Standard Deviation 0 |
| Naive Adult Onset GHD | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | -0.1 centimeters (cm) | Standard Deviation 0.78 |
| Naive Adult Onset GHD | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | -0.1 centimeters (cm) | Standard Deviation 0.79 |
| Naive Adult Onset GHD | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 0 centimeters (cm) | Standard Deviation 0 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 0 centimeters (cm) | Standard Deviation 0.17 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | 0 centimeters (cm) | Standard Deviation 0 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 0 centimeters (cm) | Standard Deviation 0.21 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | 0 centimeters (cm) | Standard Deviation 0.31 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 0 centimeters (cm) | Standard Deviation 0.35 |
Secondary
Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5
Weight of participants was measured in kg.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | -1.6 kg | Standard Deviation 8.44 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | 2.2 kg | Standard Deviation 11.41 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | 0 kg | Standard Deviation 6.55 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | -0.7 kg | Standard Deviation 6.82 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | -2.2 kg | Standard Deviation 8.02 |
| Naive Adult Onset GHD | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | -0.3 kg | Standard Deviation 13.41 |
| Naive Adult Onset GHD | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | -2.0 kg | Standard Deviation 15.37 |
| Naive Adult Onset GHD | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | -1.6 kg | Standard Deviation 12.85 |
| Naive Adult Onset GHD | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | 6.6 kg | Standard Deviation 7.24 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 2 | 1.0 kg | Standard Deviation 5.65 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 5 | -12.9 kg | Standard Deviation 20.22 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 4 | -0.3 kg | Standard Deviation 7.52 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 1 | -2.3 kg | Standard Deviation 21.49 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 | Change at Year 3 | -2.8 kg | Standard Deviation 18.16 |
Secondary
Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5
Heart rate was measured in supine position.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 69.8 beats per minute (bpm) | Standard Deviation 10.41 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 68.3 beats per minute (bpm) | Standard Deviation 9.15 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 70.2 beats per minute (bpm) | Standard Deviation 11.22 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 71.5 beats per minute (bpm) | Standard Deviation 9.9 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 68.5 beats per minute (bpm) | Standard Deviation 10.92 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 69.3 beats per minute (bpm) | Standard Deviation 9.42 |
| Naive Adult Onset GHD | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 69.8 beats per minute (bpm) | Standard Deviation 10.59 |
| Naive Adult Onset GHD | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 64.3 beats per minute (bpm) | Standard Deviation 15.34 |
| Naive Adult Onset GHD | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 68.7 beats per minute (bpm) | Standard Deviation 10.66 |
| Naive Adult Onset GHD | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 70.5 beats per minute (bpm) | Standard Deviation 14.46 |
| Naive Adult Onset GHD | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 70.7 beats per minute (bpm) | Standard Deviation 13.39 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 70.0 beats per minute (bpm) | — |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 69.7 beats per minute (bpm) | Standard Deviation 8.28 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 74.1 beats per minute (bpm) | Standard Deviation 10.79 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 71.3 beats per minute (bpm) | Standard Deviation 11.05 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 69.0 beats per minute (bpm) | Standard Deviation 11.08 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 69.4 beats per minute (bpm) | Standard Deviation 11.68 |
Secondary
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Height of participants was measured in centimeters.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 172.0 centimeters (cm) | Standard Deviation 9.2 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 173.0 centimeters (cm) | Standard Deviation 9.4 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 171.9 centimeters (cm) | Standard Deviation 9.5 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 172.1 centimeters (cm) | Standard Deviation 9.68 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 171.0 centimeters (cm) | Standard Deviation 11.44 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 171.7 centimeters (cm) | Standard Deviation 9.39 |
| Naive Adult Onset GHD | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 172.5 centimeters (cm) | Standard Deviation 10.45 |
| Naive Adult Onset GHD | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 172.5 centimeters (cm) | Standard Deviation 7.95 |
| Naive Adult Onset GHD | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 172.2 centimeters (cm) | Standard Deviation 10.67 |
| Naive Adult Onset GHD | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 172.7 centimeters (cm) | Standard Deviation 9.9 |
| Naive Adult Onset GHD | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 174.0 centimeters (cm) | Standard Deviation 10.01 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 169.1 centimeters (cm) | Standard Deviation 5.8 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 171.7 centimeters (cm) | Standard Deviation 11.81 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 170.6 centimeters (cm) | Standard Deviation 11.88 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 171.4 centimeters (cm) | Standard Deviation 12.13 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 172.8 centimeters (cm) | Standard Deviation 11.54 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 172.0 centimeters (cm) | Standard Deviation 11.6 |
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.
Time frame: Baseline up to 5 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Adverse Events Leading to Withdrawal of Genotropin Treatment | 14 adverse events |
| Naive Adult Onset GHD | Number of Adverse Events Leading to Withdrawal of Genotropin Treatment | 2 adverse events |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Adverse Events Leading to Withdrawal of Genotropin Treatment | 1 adverse events |
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.
Time frame: Baseline up to 5 years
Population: Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants Who Discontinued Study Due to Adverse Events | 5 Participants |
| Naive Adult Onset GHD | Number of Participants Who Discontinued Study Due to Adverse Events | 1 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants Who Discontinued Study Due to Adverse Events | 0 Participants |
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.
Time frame: Baseline up to 5 years
Population: Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 103 Participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 57 Participants |
| Naive Adult Onset GHD | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 17 Participants |
| Naive Adult Onset GHD | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 22 Participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10 Participants |
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.
Time frame: Baseline up to 5 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Number of Treatment Related Adverse Events | 8 adverse events |
| Naive Adult Onset GHD | Number of Treatment Related Adverse Events | 2 adverse events |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Number of Treatment Related Adverse Events | 0 adverse events |
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.
Time frame: Baseline, Year 1, 2, 3, 4
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 1 | 2.03 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 2 | 1.63 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 3 | 1.63 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 4 | 0.41 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 4 | 2.63 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 3 | 2.63 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 1 | 2.63 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 2 | 1.15 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 1 | 1.15 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 | Year 3 | 1.15 percentage of participants |
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.
Time frame: Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)
Population: All participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | Baseline | 83.0 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | During follow-up | 92.3 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | Baseline | 69.0 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | During follow-up | 73.8 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | Baseline | 83.0 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up | During follow-up | 88.6 percentage of participants |
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.
Time frame: Baseline, Year 1, 2, 3, 4
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 3 | 15.85 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 2 | 33.33 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Baseline | 48.78 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 1 | 31.30 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 4 | 2.03 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 2 | 21.05 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Baseline | 47.37 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 1 | 5.26 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 3 | 21.05 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 1 | 31.03 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 4 | 5.75 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 3 | 20.69 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Baseline | 58.62 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 | Year 2 | 34.48 percentage of participants |
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.
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 15.04 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 4.88 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 14.63 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 11.38 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 1.63 percentage of participants |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 32.93 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 7.89 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 5.26 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 42.11 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 13.16 percentage of participants |
| Naive Adult Onset GHD | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 23.68 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 1.15 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 18.39 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 6.9 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 3.45 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 5.75 percentage of participants |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 4.6 percentage of participants |
Secondary
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Weight of participants was measured in kilograms (kg).
Time frame: Baseline, Year 1, 2, 3, 4, 5
Population: FAS was analyzed. Here, Number analyzed = participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 82.8 kg | Standard Deviation 15.66 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 82.4 kg | Standard Deviation 17.83 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 83.9 kg | Standard Deviation 18.09 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 85.4 kg | Standard Deviation 18.91 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 79.5 kg | Standard Deviation 16 |
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 83.8 kg | Standard Deviation 16.76 |
| Naive Adult Onset GHD | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 84.3 kg | Standard Deviation 17.67 |
| Naive Adult Onset GHD | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 97.2 kg | Standard Deviation 9.2 |
| Naive Adult Onset GHD | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 82.4 kg | Standard Deviation 19.68 |
| Naive Adult Onset GHD | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 86.8 kg | Standard Deviation 15.54 |
| Naive Adult Onset GHD | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 86.4 kg | Standard Deviation 15.54 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 5 | 104.4 kg | Standard Deviation 0.85 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Baseline | 86.9 kg | Standard Deviation 26.11 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 1 | 84.3 kg | Standard Deviation 25.11 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 2 | 87.7 kg | Standard Deviation 20.73 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 3 | 89.4 kg | Standard Deviation 24.08 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 | Year 4 | 82.5 kg | Standard Deviation 20.66 |