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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first Genotropin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Patients administered Somatropin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | Genotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route." |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. | Up to 3 years |
| Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age. | To determine whether age is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. | To determine whether gender is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity. | To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin for Small-for-gestational Age | Participants taking somatropin for small-for-gestational age according to Japanese package insert. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin for Small-for-gestational Age | Participants taking somatropin for small-for-gestational age according to Japanese package insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Up to 3 years |
|
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The frequency of treatment related adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somatropin for Small-for-gestational Age | Participants taking somatropin for small-for-gestational age according to Japanese package insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA-J 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA-J 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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|
|
| Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. | To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications | To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder. | To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment. | To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s). | To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events. | Up to 3 years |
| Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age. | Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary. | Up to 3 years |
| Change in Height SD Score for Calendar Age. | The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25. | Up to 3 years |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | events | Up to 3 years |
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age. | To determine whether age is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. | To determine whether gender is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity. | To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. | To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications | To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder. | To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | Participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment. | To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | Participants | Up to 3 years |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s). | To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | Participants | Up to 3 years |
|
|
|
|
| Primary | Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age. | Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary. | The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed. | Posted | Mean | Standard Deviation | standard deviation (SD) score | Up to 3 years |
|
|
|
|
| Primary | Change in Height SD Score for Calendar Age. | The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25. | The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed. | Posted | Mean | Standard Deviation | standard deviation (SD) score | Up to 3 years |
|
|
|
|
| 8 |
| 890 |
| 36 |
| 890 |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Precocious puberty | Endocrine disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hyperinsulinaemia | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Pigmentation lip | Gastrointestinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Malocclusion | Gastrointestinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Insulin-like growth factor | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Thyroxine free decreased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
"The risk factor tested was "Severity". The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity.
| Cochran-Armitage Exact |
| =0.207 |
| 2-Sided |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline. |
| t-test, 1 sided |
A one-sided paired t-test was performed to test the null hypothesis. |
| <0.001 |
| 1-Sided |
| No |
| Superiority or Other |
| The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline. | t-test, 1 sided | A one-sided paired t-test was performed to test the null hypothesis. | <0.001 | 1-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline. |
| t-test, 1 sided |
A one-sided paired t-test was performed to test the null hypothesis. |
| <0.001 |
| 1-Sided |
| No |
| Superiority or Other |
| The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | 1-Sided | No | Superiority or Other |