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Increlex
Clinical Pharmacology
Increlex
N
58
58
48
38
23
21
20
16
13
Mean (SD)
2.8 (1.8)
8.0 (2.2)
5.8 (1.5)
5.5 (1.8)
4.7 (1.6)
4.7 (1.6)
4.8 (1.5)
4.6 (1.5)
4.3 (1.1)
Mean (SD) for change from pre-Tx
+5.2 (2.6)
+2.9 (2.4)
+2.3 (2.4)
+1.5 (2.2)
+1.5 (1.8)
+1.5 (1.7)
+1.0 (2.1)
+0.7 (2.5)
P-value for change from pre-Tx [1]
<0.0001
<0.0001
<0.0001
0.0045
0.0015
0.0009
0.0897
0.3059
N
58
58
47
37
22
19
18
15
11
Mean (SD)
-3.3 (1.7)
1.9 (3.0)
-0.2 (1.6)
-0.2 (2.0)
-0.7 (2.1)
-0.6 (2.1)
-0.4 (1.4)
-0.4 (1.9)
-0.4 (1.9)
Mean (SD) for change from pre-Tx
+5.2 (3.1)
+3.1 (2.3)
+2.9 (2.3)
+2.2 (2.2)
+2.5 (2.2)
+2.7 (1.7)
+2.5 (2.1)
+2.7 (2.8)
N
61
61
51
40
24
21
20
16
13
Mean (SD)
-6.7 (1.8)
-5.9 (1.8)
-5.6 (1.8)
-5.4 (1.8)
-5.5 (1.9)
-5.6 (1.8)
-5.4 (1.8)
-5.2 (2.0)
-5.2 (2.0)
Mean (SD) for change from pre-Tx
+0.8 (0.5)
+1.2 (0.8)
+1.4 (1.1)
+1.3 (1.2)
+1.4 (1.3)
+1.4 (1.2)
+1.4 (1.1)
+1.5 (1.1)
Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score
[1] P-values for comparison versus pre-Tx values are computed using paired t-tests.
Forty-nine subjects were included in an analysis of the effects of INCRELEX on bone age advancement. The mean ± SD change in chronological age was 4.9 ± 3.4 years and the mean ± SD change in bone age was 5.3 ± 3.4 years.
Generic Name: Mecasermin [rDNA origin] Injection
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