1. Adverse Events - Demographics
No. Of Events
Male (%)
Female (%)
Age (yr)*
Age Range (yr)
GH Therapy (yr)†
Adverse Events
All AEs
2.632 58
41.7
12.6
2.8
All SAEs
863 60 40
12.3
3.1
Death
156 66 34
12.4
3.5
Leukemia 20 65 35
12.9
2.6
EC milignancy 35 43 57
12.7
2.9
Brain tumor
143 61 39
12.7
3.2
ICH 49 49 51
11.7
see text
Diabetes‡ 68 58 42
13.6
3.2
SCFE 45 63 37
14.7
2.2
Scoliosis
136 45 55
14.3
3.1
Pancreatitis 5 40 60
14.0
8-17
2.7
*Age at time reported to Genentech Drug Safety Department (GDS). †Duration of growth hormone (GH) therapy up to time event reported to GDS. ‡ All patients with diabetes mellitus and glucose intolerance.
Abbildung mod. nach Maneatis T et al., 2000

2. Expected rates (per 100,000 population)
Number of observed and expected cases of leukemia
Age (yr)
Years at risk in NCGS
Expected rates (per 100,000 population)
Observed cases (no.)
Expected cases (no.)
0-4
8,012
6.8
0.54
5-9
33,635
3.3 2
1.11
10-14
65,733
2.4
1.58
15-19
65,831
2.4 2
1.58
20-24
29,101
2.4
0.70
Total 4*
5.51*
* Standard morbidity ratio = 0.73 (Cl: )
Abbildung mod. nach Maneatis T et al., 2000

3. Number of observed and expected cases of extracranial malignancy
Age
(yr)
Years at risk
in NCGS
Expected rates
(per 100,000 population)
Observed cases
(no.)
Expected cases
(no.)
0-4
8,012
16.6 1
1.33
5-9
33,635
7.1 5
2.38
10-14
65,733
9.4 4
6.18
15-19
65,831
18.9 4
12.44
20-24
29,101
32.3
9.37
Total
14*
31.70*
* Standard morbidity ratio = 0.44 (Cl ).
Abbildung mod. nach Maneatis T et al., 2000