AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 482
- 主要终点
- Number of Participants With Adverse Drug Reaction (ADR)
研究概览
简要总结
The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
详细描述
All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient who was administered Somatropin (Genotropin).
排除标准
- 未提供
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 Adverse Drug Reaction (ADR)
时间窗: Approximately 11.58 years
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
时间窗: Baseline, Year 1
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
时间窗: Baseline, Year 4
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
时间窗: Baseline, Year 6
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
时间窗: Baseline, Year 2
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
时间窗: Baseline, Year 3
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
时间窗: Baseline, Year 5
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
时间窗: Baseline, Year 7
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
时间窗: Baseline, Year 10
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
时间窗: Baseline, Year 1
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
时间窗: Baseline, Year 2
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
时间窗: Baseline, Year 3
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
时间窗: Baseline, Year 7
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
时间窗: Baseline, Year 9
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
时间窗: Baseline, Year 10
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
时间窗: Baseline, Year 4
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
时间窗: Baseline, Year 5
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
时间窗: Baseline, Year 6
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
次要结局
- Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height(Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years)
- Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline(Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years)