Table 1 Study STP-2279-002: Patient Data (Six Patients) | |||||||||||
Patient ID | Gender/Age/Race b | Start of Adagen Lead In Phase a | Adagen PK Week | Revcovi Tm Treatment Weeks 1 Through 21 d | |||||||
Weekly Dose (U/kg)b | Trough ADA Activity (mmol/hr/L) | Weekly Dose (U/kg)b | Trough ADA Activity (mmol/hr/L) |
Erythrocyte dAXP (mmol/L) |
Total Lymphocytes (x10 9 /L) | Weekly Dose (mg/kg) b | No. of Trough ADA Activity Values >15 mmol/hr/L |
No. of Erythrocyte dAXP Values < 0.02 mmol/L |
Total Lymphocytes (x10 9 /L) | ||
004-001 | Male/19/Other | 28.2 | 20.9 | 28.2 | 14.5 | < 0.02 | 0.57 | 0.188 | 13/14 | 13/14 | 0.73 |
005-001 | Male/21/Other | 29.6 | < lloq | 34.5c | 17.6 | < 0.02 | 0.52 | 0.224 | 12/13 | 13/13 | 0.99 |
005-002 | Male/37/Black or African American | 7.7 | < lloq | 30c | 22.4 | < 0.02 | 1.71 | 0.2 | 13/13 | 12/13 | 1.76 |
006-002 g | Female/30/White | 31.3 | <lloq g | 31.3 | 9.02 | < 0.02 | 0.59 | 0.209 | 10/12 | 11/11 | 0.49 |
011-001 | Female/16/White | 42.9 | 11.74 | 42.9 | 16.10 | < 0.02 | 1.17 | 0.285 | 12/13 | 12/12 | 1.39 |
012-001e | Male/18/White | 21.6 | 11.55 | 25.9c | 15.44 | < 0.02 | 0.20 | 0.17 | 8/9 | 8/8 | 0.26f |