Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

Pfizer482 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

482

Conditions

Small for Gestational Age (SGA)

Interventions

SomatropinDRUG

0.23 mg to 0.48 mg/kg/week

Eligibility

Sex: ALLMin age: 2 YearsMax age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A patient who was administered Somatropin (Genotropin). Exclusion Criteria: * N/A.

Outcomes

Primary Outcomes

Number of Participants With Adverse Drug Reaction (ADR)

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.

Time frame: Approximately 11.58 years

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At 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.

Time frame: Baseline, Year 1

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2

Time frame: Baseline, Year 2

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3

Data from ClinicalTrials.gov

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Time frame: Baseline, Year 3

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4

Time frame: Baseline, Year 4

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5

Time frame: Baseline, Year 5

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6

Time frame: Baseline, Year 6

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7

Time frame: Baseline, Year 7

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10

Time frame: Baseline, Year 10

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1

Time frame: Baseline, Year 1

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2

Time frame: Baseline, Year 2

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3

Time frame: Baseline, Year 3

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4

Time frame: Baseline, Year 4

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5

Time frame: Baseline, Year 5

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6

Time frame: Baseline, Year 6

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7

Time frame: Baseline, Year 7

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9

Time frame: Baseline, Year 9

Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10

Time frame: Baseline, Year 10

Secondary Outcomes

Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height

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. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.

Time frame: 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

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. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.

Time frame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years