Adverse Events - Demographics

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Presentation transcript:

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 1.0-41.1 2.8 All SAEs 863 60 40 12.3 1.0-41.1 3.1 Death 156 66 34 12.4 1.4-21.2 3.5 Leukemia 20 65 35 12.9 3.5-18.7 2.6 EC milignancy 35 43 57 12.7 3.2-19.5 2.9 Brain tumor 143 61 39 12.7 3.8-22.7 3.2 ICH 49 49 51 11.7 2.1-18.1 see text Diabetes‡ 68 58 42 13.6 1.3-24.4 3.2 SCFE 45 63 37 14.7 3.3-28.8 2.2 Scoliosis 136 45 55 14.3 2.5-41.1 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

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: 0.20-1.86) Abbildung mod. nach Maneatis T et al., 2000

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. 0.24-0.74). Abbildung mod. nach Maneatis T et al., 2000