Drug Use Investigation of Somatropin for GHD-ADULTS.

Study Overview
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Brief Summary
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Post marketing drug use investigation of Genotropin for GHD-ADULTS.

Detailed Description
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All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.

Official Title
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Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

Conditions
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Dwarfism, Growth Hormone Deficiency

Intervention / Treatment
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* Drug: Somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who were administered Somatropin to treat Adult growth hormone deficiency (limited to severe type). Exclusion Criteria: Patients not administered Somatropin.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Somatropin<br>Patients administered Somatropin. | Drug: Somatropin<br>* Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg. Dosage, Frequency: According to Japanese LPD, The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day. Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 6 month | 
| 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. | 6 month | 
| Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age. | To determine whether age is a significant risk factor in the frequency of treatment related adverse events. | 6 month | 
| 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. | 6 month | 
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency. | To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events. | 6 month | 
| 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. | 6 month | 
| Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin. | To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events. | 6 month | 
| Proportion of Participants Achieving Clinical Efficacy. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month | 
| Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month | 
| Proportion of Participants Achieving Clinical Efficacy by Gender. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month | 
| Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month |