Trial Outcomes & Findings for A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients (NCT NCT01947894)
NCT ID: NCT01947894
Last Updated: 2019-11-20
Results Overview
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.
COMPLETED
377 participants
Up to 5 years (after baseline visit)
2019-11-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
247
|
42
|
88
|
|
Overall Study
Treated
|
246
|
41
|
87
|
|
Overall Study
COMPLETED
|
160
|
24
|
61
|
|
Overall Study
NOT COMPLETED
|
87
|
18
|
27
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Other
|
3
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
4
|
1
|
|
Overall Study
Death
|
12
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
1
|
0
|
|
Overall Study
Switched to other growth hormone brand
|
53
|
8
|
23
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=247 Participants
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.
|
Naive Adult Onset GHD
n=42 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=88 Participants
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.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
0 to less than or equal to (<=) 18 Years
|
0 Participants
n=247 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=377 Participants
|
|
Age, Customized
Greater than (>) 18 to less than (<) 65 Years
|
138 Participants
n=247 Participants
|
38 Participants
n=42 Participants
|
83 Participants
n=88 Participants
|
259 Participants
n=377 Participants
|
|
Age, Customized
>=65 Years
|
100 Participants
n=247 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=88 Participants
|
106 Participants
n=377 Participants
|
|
Age, Customized
Unknown
|
9 Participants
n=247 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=88 Participants
|
12 Participants
n=377 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=247 Participants
|
22 Participants
n=42 Participants
|
42 Participants
n=88 Participants
|
184 Participants
n=377 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=247 Participants
|
20 Participants
n=42 Participants
|
46 Participants
n=88 Participants
|
193 Participants
n=377 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
IGF-I LLN
|
11 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
IGF-I ULN
|
63 Participants
|
8 Participants
|
30 Participants
|
|
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
IGF-I ULN within reference range
|
159 Participants
|
22 Participants
|
47 Participants
|
|
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
IGF-I Unknown
|
13 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=41 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
103 Participants
|
17 Participants
|
22 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
57 Participants
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=103 Participants
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.
|
Naive Adult Onset GHD
n=17 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=22 Participants
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.
|
|---|---|---|---|
|
Number of Treatment Related Adverse Events
|
8 adverse events
|
2 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=103 Participants
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.
|
Naive Adult Onset GHD
n=117 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=22 Participants
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.
|
|---|---|---|---|
|
Number of Adverse Events Leading to Withdrawal of Genotropin Treatment
|
14 adverse events
|
2 adverse events
|
1 adverse events
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=41 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Due to Adverse Events
|
5 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Weight of participants was measured in kilograms (kg).
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Baseline
|
83.8 kg
Standard Deviation 16.76
|
82.4 kg
Standard Deviation 19.68
|
86.9 kg
Standard Deviation 26.11
|
|
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 1
|
83.9 kg
Standard Deviation 18.09
|
86.4 kg
Standard Deviation 15.54
|
84.3 kg
Standard Deviation 25.11
|
|
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 2
|
82.8 kg
Standard Deviation 15.66
|
86.8 kg
Standard Deviation 15.54
|
87.7 kg
Standard Deviation 20.73
|
|
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 3
|
85.4 kg
Standard Deviation 18.91
|
84.3 kg
Standard Deviation 17.67
|
89.4 kg
Standard Deviation 24.08
|
|
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 4
|
82.4 kg
Standard Deviation 17.83
|
97.2 kg
Standard Deviation 9.20
|
82.5 kg
Standard Deviation 20.66
|
|
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 5
|
79.5 kg
Standard Deviation 16.00
|
—
|
104.4 kg
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Weight of participants was measured in kg.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
-2.0 kg
Standard Deviation 15.37
|
-2.3 kg
Standard Deviation 21.49
|
|
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
|
-1.6 kg
Standard Deviation 12.85
|
1.0 kg
Standard Deviation 5.65
|
|
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
|
-0.3 kg
Standard Deviation 13.41
|
-2.8 kg
Standard Deviation 18.16
|
|
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
|
6.6 kg
Standard Deviation 7.24
|
-0.3 kg
Standard Deviation 7.52
|
|
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
|
—
|
-12.9 kg
Standard Deviation 20.22
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Height of participants was measured in centimeters.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Baseline
|
171.7 centimeters (cm)
Standard Deviation 9.39
|
172.2 centimeters (cm)
Standard Deviation 10.67
|
171.7 centimeters (cm)
Standard Deviation 11.81
|
|
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 1
|
171.9 centimeters (cm)
Standard Deviation 9.50
|
174.0 centimeters (cm)
Standard Deviation 10.01
|
170.6 centimeters (cm)
Standard Deviation 11.88
|
|
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 2
|
172.0 centimeters (cm)
Standard Deviation 9.20
|
172.7 centimeters (cm)
Standard Deviation 9.90
|
171.4 centimeters (cm)
Standard Deviation 12.13
|
|
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 3
|
172.1 centimeters (cm)
Standard Deviation 9.68
|
172.5 centimeters (cm)
Standard Deviation 10.45
|
172.8 centimeters (cm)
Standard Deviation 11.54
|
|
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 4
|
173.0 centimeters (cm)
Standard Deviation 9.40
|
172.5 centimeters (cm)
Standard Deviation 7.95
|
172.0 centimeters (cm)
Standard Deviation 11.60
|
|
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 5
|
171.0 centimeters (cm)
Standard Deviation 11.44
|
—
|
169.1 centimeters (cm)
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Height of participants was measured in centimeters.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
-0.1 centimeters (cm)
Standard Deviation 0.78
|
0 centimeters (cm)
Standard Deviation 0.31
|
|
Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5
Change at Year 2
|
0 centimeters (cm)
Standard Deviation 0.30
|
-0.1 centimeters (cm)
Standard Deviation 0.79
|
0 centimeters (cm)
Standard Deviation 0.17
|
|
Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5
Change at Year 3
|
0 centimeters (cm)
Standard Deviation 0.60
|
0 centimeters (cm)
Standard Deviation 0
|
0 centimeters (cm)
Standard Deviation 0.35
|
|
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
|
0 centimeters (cm)
Standard Deviation 0
|
0 centimeters (cm)
Standard Deviation 0.21
|
|
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
|
—
|
0 centimeters (cm)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
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).
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
27.8 Kilogram per meter squared (kg/m^2)
Standard Deviation 5.71
|
29.6 Kilogram per meter squared (kg/m^2)
Standard Deviation 8.42
|
|
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
|
28.3 Kilogram per meter squared (kg/m^2)
Standard Deviation 5.56
|
28.9 Kilogram per meter squared (kg/m^2)
Standard Deviation 7.26
|
|
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 4.20
|
28.9 Kilogram per meter squared (kg/m^2)
Standard Deviation 4.70
|
29.8 Kilogram per meter squared (kg/m^2)
Standard Deviation 6.08
|
|
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
|
28.5 Kilogram per meter squared (kg/m^2)
Standard Deviation 4.70
|
29.8 Kilogram per meter squared (kg/m^2)
Standard Deviation 6.47
|
|
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
|
33.2 Kilogram per meter squared (kg/m^2)
Standard Deviation 2.92
|
28.2 Kilogram per meter squared (kg/m^2)
Standard Deviation 7.24
|
|
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
|
—
|
36.6 Kilogram per meter squared (kg/m^2)
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
-0.4 kg/m^2
Standard Deviation 4.60
|
-0.9 kg/m^2
Standard Deviation 7.79
|
|
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
|
-0.5 kg/m^2
Standard Deviation 3.84
|
0.3 kg/m^2
Standard Deviation 2.03
|
|
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
|
-0.3 kg/m^2
Standard Deviation 4.13
|
-1.1 kg/m^2
Standard Deviation 6.02
|
|
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
|
1.8 kg/m^2
Standard Deviation 2.43
|
-0.1 kg/m^2
Standard Deviation 2.54
|
|
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
|
—
|
-4.3 kg/m^2
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
123.6 millimeter of mercury (mmHg)
Standard Deviation 13.47
|
120.3 millimeter of mercury (mmHg)
Standard Deviation 13.40
|
|
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
|
127.4 millimeter of mercury (mmHg)
Standard Deviation 16.00
|
122.9 millimeter of mercury (mmHg)
Standard Deviation 11.74
|
|
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
|
133.5 millimeter of mercury (mmHg)
Standard Deviation 21.97
|
124.1 millimeter of mercury (mmHg)
Standard Deviation 14.37
|
|
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
|
130.4 millimeter of mercury (mmHg)
Standard Deviation 20.13
|
123.4 millimeter of mercury (mmHg)
Standard Deviation 14.26
|
|
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 14.80
|
134.4 millimeter of mercury (mmHg)
Standard Deviation 14.01
|
127.8 millimeter of mercury (mmHg)
Standard Deviation 13.97
|
|
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
|
—
|
121.0 millimeter of mercury (mmHg)
Standard Deviation 1.41
|
|
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
|
75.5 millimeter of mercury (mmHg)
Standard Deviation 10.76
|
74.0 millimeter of mercury (mmHg)
Standard Deviation 8.29
|
|
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
|
73.0 millimeter of mercury (mmHg)
Standard Deviation 11.00
|
74.6 millimeter of mercury (mmHg)
Standard Deviation 9.01
|
|
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 9.10
|
75.8 millimeter of mercury (mmHg)
Standard Deviation 12.32
|
76.3 millimeter of mercury (mmHg)
Standard Deviation 9.06
|
|
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
|
77.2 millimeter of mercury (mmHg)
Standard Deviation 10.99
|
76.0 millimeter of mercury (mmHg)
Standard Deviation 7.84
|
|
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
|
80.6 millimeter of mercury (mmHg)
Standard Deviation 11.91
|
76.1 millimeter of mercury (mmHg)
Standard Deviation 8.04
|
|
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
|
—
|
70.5 millimeter of mercury (mmHg)
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Measurement of BP included supine SBP and DBP.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
-0.9 mmHg
Standard Deviation 11.52
|
3.4 mmHg
Standard Deviation 13.52
|
|
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
|
6.1 mmHg
Standard Deviation 17.48
|
2.3 mmHg
Standard Deviation 12.81
|
|
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
|
1.5 mmHg
Standard Deviation 17.11
|
4.3 mmHg
Standard Deviation 12.41
|
|
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
|
10.5 mmHg
Standard Deviation 10.65
|
4.3 mmHg
Standard Deviation 16.40
|
|
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
|
—
|
-4.0 mmHg
Standard Deviation 8.49
|
|
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
|
-4.2 mmHg
Standard Deviation 10.2
|
0.6 mmHg
Standard Deviation 9.83
|
|
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
|
0.5 mmHg
Standard Deviation 11.81
|
1.8 mmHg
Standard Deviation 8.17
|
|
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
|
-0.4 mmHg
Standard Deviation 8.2
|
0.8 mmHg
Standard Deviation 8.81
|
|
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
|
-2.8 mmHg
Standard Deviation 9.77
|
2.0 mmHg
Standard Deviation 9.50
|
|
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
|
—
|
0.5 mmHg
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Heart rate was measured in supine position.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5
Baseline
|
69.3 beats per minute (bpm)
Standard Deviation 9.42
|
68.7 beats per minute (bpm)
Standard Deviation 10.66
|
69.7 beats per minute (bpm)
Standard Deviation 8.28
|
|
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
|
70.7 beats per minute (bpm)
Standard Deviation 13.39
|
74.1 beats per minute (bpm)
Standard Deviation 10.79
|
|
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
|
70.5 beats per minute (bpm)
Standard Deviation 14.46
|
71.3 beats per minute (bpm)
Standard Deviation 11.05
|
|
Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5
Year 3
|
71.5 beats per minute (bpm)
Standard Deviation 9.90
|
69.8 beats per minute (bpm)
Standard Deviation 10.59
|
69.0 beats per minute (bpm)
Standard Deviation 11.08
|
|
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
|
64.3 beats per minute (bpm)
Standard Deviation 15.34
|
69.4 beats per minute (bpm)
Standard Deviation 11.68
|
|
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
|
—
|
70.0 beats per minute (bpm)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was analyzed.
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Heart rate was measured in supine position.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
-1.4 bpm
Standard Deviation 12.66
|
4.7 bpm
Standard Deviation 12.06
|
|
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
|
1.8 bpm
Standard Deviation 14.88
|
3.4 bpm
Standard Deviation 11.47
|
|
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
|
1.5 bpm
Standard Deviation 13.94
|
1.6 bpm
Standard Deviation 15.11
|
|
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
|
1.0 bpm
Standard Deviation 16.31
|
0.7 bpm
Standard Deviation 9.76
|
|
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
|
—
|
0 bpm
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was analyzed.
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
Body composition included parameters fat mass and muscle mass.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Baseline
|
48.78 percentage of participants
|
47.37 percentage of participants
|
58.62 percentage of participants
|
|
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Year 1
|
31.30 percentage of participants
|
5.26 percentage of participants
|
31.03 percentage of participants
|
|
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Year 2
|
33.33 percentage of participants
|
21.05 percentage of participants
|
34.48 percentage of participants
|
|
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Year 3
|
15.85 percentage of participants
|
21.05 percentage of participants
|
20.69 percentage of participants
|
|
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Year 4
|
2.03 percentage of participants
|
—
|
5.75 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4, 5Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
42.11 percentage of participants
|
18.39 percentage of participants
|
|
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
|
23.68 percentage of participants
|
6.9 percentage of participants
|
|
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
|
13.16 percentage of participants
|
3.45 percentage of participants
|
|
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
|
7.89 percentage of participants
|
5.75 percentage of participants
|
|
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
|
5.26 percentage of participants
|
4.6 percentage of participants
|
|
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
|
—
|
1.15 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3, 4Population: FAS was analyzed. Here, "Number analyzed" = participants who were evaluable at specified time points for each arm, respectively.
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.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 Participants
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.
|
Naive Adult Onset GHD
n=38 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 Participants
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.
|
|---|---|---|---|
|
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
|
2.63 percentage of participants
|
1.15 percentage of participants
|
|
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
|
—
|
1.15 percentage of participants
|
|
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
|
2.63 percentage of participants
|
1.15 percentage of participants
|
|
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
|
2.63 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)Population: All participants who were enrolled in the study.
Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported.
Outcome measures
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=247 Participants
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.
|
Naive Adult Onset GHD
n=42 Participants
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=88 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up
Baseline
|
83.0 percentage of participants
|
69.0 percentage of participants
|
83.0 percentage of participants
|
|
Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up
During follow-up
|
92.3 percentage of participants
|
73.8 percentage of participants
|
88.6 percentage of participants
|
Adverse Events
KIMS Adult Onset Growth Hormone Deficiency (GHD)
Naive Adult Onset GHD
Childhood Onset Growth Hormone Deficiency (CO-GHD)
Serious adverse events
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 participants at risk
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.
|
Naive Adult Onset GHD
n=41 participants at risk
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 participants at risk
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.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
3/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
3/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
3/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Angina pectoris
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Palpitations
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Angina unstable
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Pneumonia
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Influenza
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Sepsis
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Abscess
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Meningitis
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Periodontitis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Erysipelas
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Respiratory tract infection
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Syncope
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Headache
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Endocrine disorders
Cortisol deficiency
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Endocrine disorders
Hyperparat hyroidism
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Endocrine disorders
Pituitary apoplexy
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
General disorders
Chest pain
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
General disorders
Dysplasia
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
General disorders
Pyrexia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Strangulated incisional hernia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Melaena
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Psychiatric disorders
Depression
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Psychiatric disorders
Major depression
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Macular degeneration
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Retinal detachment
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
1.1%
1/87 • 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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Aortic dissection
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Congenital, familial and genetic disorders
Neurofibromatosis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Surgical and medical procedures
Amputation
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
Other adverse events
| Measure |
KIMS Adult Onset Growth Hormone Deficiency (GHD)
n=246 participants at risk
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.
|
Naive Adult Onset GHD
n=41 participants at risk
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.
|
Childhood Onset Growth Hormone Deficiency (CO-GHD)
n=87 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.41%
1/246 • 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.
|
7.3%
3/41 • 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.
|
1.1%
1/87 • 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.
|
|
Nervous system disorders
Dizziness
|
1.2%
3/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Visual field defect
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Syncope
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Nervous system disorders
Sciatica
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Nervous system disorders
Dementia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Hypoaesthesia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Tremor
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Nervous system disorders
Memory impairment
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Influenza
|
0.81%
2/246 • 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.
|
2.4%
1/41 • 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.
|
2.3%
2/87 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
1.1%
1/87 • 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.
|
|
Infections and infestations
Pharyngitis
|
0.81%
2/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Infections and infestations
Sinusitis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Infections and infestations
Gastroenteritis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Infections and infestations
Upper respiratory track infection
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Tonsillitis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Tooth infection
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Pulpitis dental
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Infections and infestations
Malaria
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
2.3%
2/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
General disorders
Fatigue
|
2.8%
7/246 • 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.
|
4.9%
2/41 • 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.
|
2.3%
2/87 • 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.
|
|
General disorders
Pyrexia
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
General disorders
Chest pain
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
General disorders
Peripheral swelling
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Prostatic specific antigen increased
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Haemoglobin decreased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Weight increased
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Weight decreased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Colonoscopy
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Hepatic enzyme increased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Blood prolactin increased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Blood testosterone increased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Blood homocysteine increased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Investigations
Blood folate decreased
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Gastrointestinal disorders
Haematemesis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Injury, poisoning and procedural complications
Wound
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Hypertension
|
1.2%
3/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Venous thrombosis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Thrombophlebitis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Psychiatric disorders
Depression
|
0.41%
1/246 • 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.
|
4.9%
2/41 • 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.
|
1.1%
1/87 • 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.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Psychiatric disorders
Insomnia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.2%
3/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Endocrine disorders
Hyperparat hyroidism primary
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Eye disorders
Cataract
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Vitreous detachment
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Dry eye
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Diabetic retinopathy
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Visual impairment
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Eye disorders
Macular oedema
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.41%
1/246 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/87 • 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.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/246 • 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.
|
2.4%
1/41 • 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.
|
1.1%
1/87 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.81%
2/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Surgical and medical procedures
Gastric banding
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
1.1%
1/87 • 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.
|
|
Product Issues
Syringe issue
|
0.41%
1/246 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/87 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER