Table 1.
Demographic and baseline characteristics
| Characteristic | Orvepitant 30 mg n=16 |
Orvepitant 10 mg n=14 |
Placebo n=14 |
Total n=44 |
| Age (years), median (range) | 69.0 (43–83) | 73.5 (49–81) | 67.0 (35–76) | 68.0 (35–83) |
| Age groups, n (%) | ||||
| <65 years | 4 (25.0) | 4 (28.6) | 4 (28.6) | 12 (27.3) |
| ≥65 years | 12 (75.0) | 10 (71.4) | 10 (71.4) | 32 (72.7) |
| Gender, n (%) | ||||
| Female | 5 (31.3) | 5 (35.7) | 8 (57.1) | 18 (40.9) |
| Male | 11 (68.8) | 9 (64.3) | 6 (42.9) | 26 (59.1) |
| Race, n (%) | ||||
| Caucasian | 16 (100.0) | 14 (100.0) | 14 (100.0) | 44 (100.0) |
| Time since cancer diagnosis (months), median (range) | 17.5 (1–131) | 29.7 (12–129) | 20.8 (5–60) | 23.0 (1–131) |
| Patient-reported NRS score | ||||
| Mean (SD) | 6.68 (1.278) | 6.95 (1.413) | 5.88 (0.930) | NC |
| Median (range) | 6.86 (4.8–9.3) | 7.00 (5.0–10.0) | 5.57 (5.0–7.4) | NC |
| Pruritus | ||||
| CTCAE grade, n (%) | ||||
| Grade 1 | 2 (12.5) | 0 | 0 | 2 (4.5) |
| Grade 2 | 8 (50.0) | 9 (64.3) | 11 (78.6) | 28 (63.6) |
| Grade 3 | 5 (31.3) | 5 (35.7) | 3 (21.4) | 13 (29.5) |
| Unknown | 1 (6.3) | 0 | 0 | 1 (2.3) |
| Location, n (%) | ||||
| Head | 8 (50.0) | 6 (42.9) | 12 (85.7) | 26 (59.1) |
| Trunk | 7 (43.8) | 3 (21.4) | 1 (7.1) | 11 (25.0) |
| Arms | 0 | 3 (21.4) | 0 | 3 (6.8) |
| Legs | 0 | 2 (14.3) | 1 (7.1) | 3 (6.8) |
| Unknown | 1 (6.3) | 0 | 0 | 1 (2.3) |
| Acneiform rash | ||||
| CTCAE grade, n (%) | ||||
| Grade 1 | 2 (12.5) | 3 (21.4) | 2 (14.3) | 7 (15.9) |
| Grade 2 | 7 (43.8) | 7 (50.0) | 10 (71.4) | 24 (54.5) |
| Grade 3 | 6 (37.5) | 3 (21.4) | 1 (7.1) | 10 (22.7) |
| Unknown | 1 (6.3) | 1 (7.1) | 1 (7.1) | 3 (6.8) |
| Location, n (%) | ||||
| Head | 7 (43.8) | 5 (35.7) | 11 (78.6) | 23 (52.3) |
| Trunk | 7 (43.8) | 5 (35.7) | 0 | 12 (27.3) |
| Arms | 1 (6.3) | 3 (21.4) | 1 (7.1) | 5 (11.4) |
| Legs | 0 | 0 | 1 (7.1) | 1 (2.3) |
| Unknown | 1 (6.3) | 1 (7.1) | 1 (7.1) | 3 (6.8) |
| Maculopapular rash | ||||
| CTCAE grade, n (%) | ||||
| Grade 1 | 3 (18.8) | 5 (35.7) | 5 (35.7) | 13 (29.5) |
| Grade 2 | 8 (50.0) | 5 (35.7) | 8 (57.1) | 21 (47.7) |
| Grade 3 | 4 (25.0) | 3 (21.4) | 0 | 7 (15.9) |
| Unknown | 1 (6.3) | 1 (7.1) | 1 (7.1) | 3 (6.8) |
| Location, n (%) | ||||
| Head | 7 (43.8) | 5 (35.7) | 12 (85.7) | 24 (54.5) |
| Trunk | 7 (43.8) | 4 (28.6) | 0 | 11 (25.0) |
| Arms | 1 (6.3) | 4 (28.6) | 0 | 5 (11.4) |
| Legs | 0 | 0 | 1 (7.1) | 1 (2.3) |
| Unknown | 1 (6.3) | 1 (7.1) | 1 (7.1) | 3 (6.8) |
CTCAE, Common Terminology Criteria for Adverse Events; NC, not calculated; NRS, numerical rating scale.