Table 1 Demographics and patient disposition by treatment groups.
Demographic variables | 10 mg Reg 1, N = 3 | 20 mg Reg 1, N = 4 | 40 mg Reg 1, N = 4 | 80 mg Reg 1, N = 4 | 150 mg Reg 1, N = 4 | 300 mg Reg 1, N = 7 | 400 mg Reg 1, N = 5 | 300 mg Reg 3, N = 8 | 500 mg Reg 3, N = 6 | 700 mg Reg 3, N = 6 | All patients, N = 51 |
|---|---|---|---|---|---|---|---|---|---|---|---|
Age (years) | |||||||||||
Mean (SD) | 47 (8.89) | 50 (9.13) | 50.8 (13.65) | 59.3 (5.38) | 44.5 (7.0) | 58.7 (7.67) | 56.8 (12.05) | 50.3 (12.51) | 56.3 (11.55) | 56.7 (8.26) | 53.6 (10.33) |
Age group (years), n (%) | |||||||||||
<65 | 3 (100) | 4 (100) | 3 (75.0) | 3 (75.0) | 4 (100) | 5 (71.4) | 3 (60.0) | 7 (87.5) | 5 (83.3) | 5 (83.3) | 42 (82.4) |
≥65 | 0 | 0 | 1 (25.0) | 1 (25.0) | 0 | 2 (28.6) | 2 (40.0) | 1 (12.5) | 1 (16.7) | 1 (16.7) | 9 (17.6) |
Sex, n (%) | |||||||||||
Male | 1 (33.3) | 3 (75.0) | 3 (75.0) | 2 (50.0) | 1 (25.0) | 2 (28.6) | 2 (40.0) | 3 (37.5) | 2 (33.3) | 3 (50.0) | 22 (43.1) |
Female | 2 (66.7) | 1 (25.0) | 1 (25.0) | 2 (50.0) | 3 (75.0) | 5 (71.4) | 3 (60.0) | 5 (62.5) | 4 (66.7) | 3 (50.0) | 29 (56.9) |
WHO PS, n (%) | |||||||||||
0 | 2 (66.7) | 3 (75.0) | 3 (75.0) | 2 (50.0) | 2 (50.0) | 4 (57.1) | 4 (80.0) | 4 (50.0) | 3 (50.0) | 4 (66.7) | 31 (60.8) |
1 | 0 | 1 (25.0) | 0 | 1 (25.0) | 2 (50.0) | 2 (28.6) | 1 (20.0) | 4 (50.0) | 3 (50.0) | 2 (33.3) | 16 (31.4) |
2 | 1 (33.3) | 0 | 1 (25.0) | 1 (25.0) | 0 | 1 (14.3) | 0 | 0 | 0 | 0 | 4 (7.8) |
Patient disposition, n (%) | |||||||||||
Treatment discontinued | 3 (100) | 4 (100) | 4 (100) | 4 (100) | 4 (100) | 6 (85.7) | 4 (80.0) | 8 (100) | 6 (100) | 6 (100) | 49 (96.1) |
Treatment ongoing | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 1 (20.0) | 0 | 0 | 0 | 2 (3.9) |
Primary reason for treatment end, n (%) | |||||||||||
Adverse event | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 2 (40.0) | 1 (12.5) | 0 | 1 (16.7) | 5 (9.8) |
Consent withdrawn | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.0) |
Death | 1 (33.3) | 0 | 1 (25.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.9) |
Disease progression | 2 (66.7) | 4 (100) | 3 (75.0) | 4 (100) | 4 (100) | 5 (71.4) | 2 (40.0) | 7 (87.5) | 6 (100) | 4 (66.7) | 41 (80.4) |
