Long Term Use of Somatropin in Patients Small for Gestational Age

Status

Completed

Phase

Phase not stated

Enrollment

920 participants (actual)

Sponsor

Pfizer · Industry

Design

Not stated

Countries

Not stated

Start

Feb 2009

Primary completion

Dec 2012

Completion

Dec 2012

First posted

19 Nov 2008 (estimated)

Last update posted

6 Feb 2014 (estimated)

Conditions

Small for Gestational Age

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.

• Other

  Somatropin

  Patients administered Somatropin.

1. Number of Participants With Treatment Related Adverse Events.

   Time frame · Up to 3 years

   Registry description

   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.

2. Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

   Time frame · Up to 3 years

   Registry description

   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.

3. Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.

   Time frame · Up to 3 years

   Registry description

   To determine whether age is a significant risk factor in the frequency of treatment related adverse events.

4. Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

   Time frame · Up to 3 years

   Registry description

   To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.

5. Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.

   Time frame · Up to 3 years

   Registry description

   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.

6. Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.

   Time frame · Up to 3 years

   Registry description

   To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.

7. Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications

   Time frame · Up to 3 years

   Registry description

   To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.

8. Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.

   Time frame · Up to 3 years

   Registry description

   To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.

9. Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.

   Time frame · Up to 3 years

   Registry description

   To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.

10. Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).

    Time frame · Up to 3 years

    Registry description

    To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.

11. Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.

    Time frame · Up to 3 years

    Registry description

    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.

12. Change in Height SD Score for Calendar Age.

    Time frame · Up to 3 years

    Registry description

    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.

No study cites this trial.