Drug Use Investigation of GENOTROPIN for GHD-ADULTS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 230
- 主要终点
- Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.
研究概览
简要总结
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
详细描述
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".
排除标准
- •Patients not administered Somatropin.
研究组 & 干预措施
Somatropin
Patients administered Somatropin.
干预措施: Somatropin (Drug)
结局指标
主要结局
Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.
时间窗: 6 month
To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events.
时间窗: 6 month
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.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
时间窗: 6 month
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.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
时间窗: 6 month
To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.
时间窗: 6 month
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.
Proportion of Participants Achieving Clinical Efficacy by Gender.
时间窗: 6 month
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.
Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.
时间窗: 6 month
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.
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
时间窗: 6 month
To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.
时间窗: 6 month
To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.
时间窗: 6 month
To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.
Proportion of Participants Achieving Clinical Efficacy.
时间窗: 6 month
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.
次要结局
未报告次要终点