Table 1.
Phase 2b patient demographics at baseline (full analysis set)
|
Study part 1 |
Study part 2 |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| RTB101 5 mg (n=61) | RTB101 10 mg once daily (n=58) | Placebo (n=60) | Overall (n=179) | RTB101 10 mg once daily (n=118) | RTB101 10 mg twice daily (n=120) | RTB101 plus everolimus (n=115) | Placebo (n=120) | Overall (n=473) | |
| Age at randomisation, years | |||||||||
| Mean (SD) | 74·0 (8·2) | 76·5 (7·9) | 74·4 (7·3) | 74·9 (7·9) | 73·1 (6·9) | 73·0 (6·9) | 73·9 (7·0) | 73·2 (7·2) | 73·3 (7·0) |
| Median (IQR) | 71·0 (68·0–79·0) | 76·0 (69·0–82·0) | 72·0 (69·0–79·0) | 72·0 (69·0–80·0) | 71·0 (68·0–77·0) | 71·0 (67·5–78·0) | 73·0 (68·0–78·0) | 71·0 (68·0–77·0) | 71·0 (68·0–78·0) |
| Sex | |||||||||
| Male | 33 (54%) | 31 (53)% | 36 (60%) | 100 (56%) | 52 (44%) | 61 (501%) | 57 (50%) | 53 (44%) | 223 (47%) |
| Female | 28 (46%) | 27 (47%) | 24 (40%) | 79 (44%) | 66 (56%) | 59 (49%) | 58 (50%) | 67 (56%) | 250 (53%) |
| Race | |||||||||
| White | 56 (92%) | 54 (93%) | 57 (95%) | 167 (93%) | 114 (97%) | 110 (91%) | 106 (92%) | 109 (91%) | 439 (93%) |
| Black or African American | 0 | 0 | 0 | 0 | 4 (3%) | 9 (8%) | 5 (4%) | 10 (8%) | 28 (6%) |
| Native Hawaiian or other Pacific Islander | 2 (3%) | 2 (3%) | 2 (3%) | 6 (3%) | 0 | 0 | 0 | 0 | 0 |
| Other | 1 (2%) | 0 | 1 (1·7%) | 2 (1%) | 0 | 0 | 2 (1·7%) | 1 (<1%) | 3 (<1%) |
| Asian | 2 (3%) | 2 (3%) | 0 | 4 (2%) | 0 | 0 | 1 (<1%) | 0 | 1 (<1%) |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 1 (<1%) | 1 (<1%) | 0 | 2 (<1%) |
| Ethnicity | |||||||||
| Not-Hispanic or Latino | 61 (100%) | 58 (100%) | 60 (100%) | 179 (100%) | 108 (92%) | 114 (95%) | 101 (88%) | 108 (90%) | 431 (91%) |
| Hispanic or Latino | 0 | 0 | 0 | 0 | 10 (9%) | 6 (5%) | 14 (12%) | 12 (10%) | 42 (9%) |
| BMI at baseline (kg/m2) | |||||||||
| Mean (SD) | 28·4 (5·1) | 30·0 (5·8) | 28·6 (5·5) | 29·0 (5·5) | 30·9 (6·9) | 31·2 (6·1) | 30·1 (6·8) | 30·5 (6·0) | 30·7 (6·5) |
Data are n (%), unless otherwise specified.