Demographic and baseline characteristics of the RESET full analysis population
Characteristics . | RESET rivipansel (n = 173) . | RESET placebo (n = 172) . | OLE rivipansel (n = 38) . |
---|---|---|---|
Age, mean (SD), y | 22.0 (10.6) | 21.3 (10.2) | 17.3 (6.6) |
Aged 6-11 y (RESET: 26 rivipansel, 26 placebo; OLE: 6) | 9.5 (1.8) | 9.3 (1.7) | 7.5 (1.4) |
Aged 12-17 y (RESET: 45 rivipansel, 44 placebo; OLE: 15) | 14.9 (1.8) | 14.7 (1.8) | 14.9 (2.0) |
Aged ≥18 y (RESET: 102 rivipansel, 102 placebo; OLE: 17) | 28.3 (9.3) | 27.3 (9.1) | 22.9 (4.5) |
Male sex, no. of patients (%) | 89 (51.4) | 73 (42.4) | 23 (60.5) |
Race,no. of patients (%) | |||
White | 0 (0.0) | 6 (3.5) | 0 (0.0) |
Black | 167 (96.5) | 159 (92.4) | 36 (94.7) |
Other | 6 (3.5) | 7 (4.1) | 2 (5.3) |
Genotype,no. of patients (%) | |||
Category 1: HbSS, HbSβ0-thalassemia, and HbSD | 132 (76.3) | 129 (75.0) | 33 (86.8) |
Category 2: HbSC, HbS β+-thalassemia, and HbS-variant other than HbSD | 41 (23.7) | 43 (25.0) | 5 (13.2) |
Hydroxyurea use — no. of patients (%) | 117 (67.6) | 111 (64.5) | 30 (78.9) |
Aged 6-11 y | 16 (13.7) | 17 (15.3) | 5 (83.3) |
Aged 12-17 y | 36 (30.8) | 31 (27.9) | 12 (80.0) |
Aged ≥18 y | 65 (55.6) | 63 (56.8) | 13 (76.5) |
Daily use of analgesic medications at home,no. of patients (%) | 40 (23.1) | 44 (25.6)∗ | 6 (15.8)† |
Aged 6-11 y | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Aged 12-17 y | 2 (5.0) | 1 (2.3)∗ | 0 (0.0)† |
Aged ≥18 y | 38 (95.0) | 43 (97.7) | 6 (100) |
Characteristics . | RESET rivipansel (n = 173) . | RESET placebo (n = 172) . | OLE rivipansel (n = 38) . |
---|---|---|---|
Age, mean (SD), y | 22.0 (10.6) | 21.3 (10.2) | 17.3 (6.6) |
Aged 6-11 y (RESET: 26 rivipansel, 26 placebo; OLE: 6) | 9.5 (1.8) | 9.3 (1.7) | 7.5 (1.4) |
Aged 12-17 y (RESET: 45 rivipansel, 44 placebo; OLE: 15) | 14.9 (1.8) | 14.7 (1.8) | 14.9 (2.0) |
Aged ≥18 y (RESET: 102 rivipansel, 102 placebo; OLE: 17) | 28.3 (9.3) | 27.3 (9.1) | 22.9 (4.5) |
Male sex, no. of patients (%) | 89 (51.4) | 73 (42.4) | 23 (60.5) |
Race,no. of patients (%) | |||
White | 0 (0.0) | 6 (3.5) | 0 (0.0) |
Black | 167 (96.5) | 159 (92.4) | 36 (94.7) |
Other | 6 (3.5) | 7 (4.1) | 2 (5.3) |
Genotype,no. of patients (%) | |||
Category 1: HbSS, HbSβ0-thalassemia, and HbSD | 132 (76.3) | 129 (75.0) | 33 (86.8) |
Category 2: HbSC, HbS β+-thalassemia, and HbS-variant other than HbSD | 41 (23.7) | 43 (25.0) | 5 (13.2) |
Hydroxyurea use — no. of patients (%) | 117 (67.6) | 111 (64.5) | 30 (78.9) |
Aged 6-11 y | 16 (13.7) | 17 (15.3) | 5 (83.3) |
Aged 12-17 y | 36 (30.8) | 31 (27.9) | 12 (80.0) |
Aged ≥18 y | 65 (55.6) | 63 (56.8) | 13 (76.5) |
Daily use of analgesic medications at home,no. of patients (%) | 40 (23.1) | 44 (25.6)∗ | 6 (15.8)† |
Aged 6-11 y | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Aged 12-17 y | 2 (5.0) | 1 (2.3)∗ | 0 (0.0)† |
Aged ≥18 y | 38 (95.0) | 43 (97.7) | 6 (100) |