Table 3.
Summary of secondary efficacy endpoints
Statistic | Orvepitant 30 mg n=16 |
Orvepitant 10 mg n=14 |
Placebo n=14 |
Change from baseline, (n) mean (SD) | |||
Patient-recorded NRS score (last three recordings) at week 1 | (16) −1.18 (1.55) | (13) −1.66 (2.48) | (14) −1.16 (1.41) |
Patient-recorded NRS score (last three recordings) at week 2 | (14) −2.33 (2.00) | (13) −2.85 (3.43) | (13) −2.76 (1.96) |
Patient-recorded NRS score (last three recordings) at week 3 | (14) −2.16 (2.56) | (11) −3.14 (2.77) | (14) −3.26 (2.00) |
Patient-recorded NRS score (last three recordings) at week 5 | (13) −3.19 (2.88) | (10) −3.32 (3.19) | (14) −3.90 (2.19) |
Patient-recorded NRS score (last three recordings) at week 6 | (13) −3.24 (2.89) | (10) −3.68 (2.55) | (13) −4.00 (1.78) |
Patient-recorded NRS score (last three recordings) at week 7 | (12) −2.49 (2.91) | (10) −2.85 (2.52) | (12)−4.13 (2.33) |
Patient-recorded NRS score (last three recordings) at week 8 | (11) −2.86 (2.91) | (10) −3.18 (2.68) | (12) −4.32 (2.27) |
Patient-recorded NRS score (all week) at week 1 | (16) −0.96 (1.09) | (13) −1.34 (1.93) | (14) −0.86 (1.00) |
Patient-recorded NRS score (all week) at week 4 | (13) −2.64 (2.61) | (11) −3.05 (3.00) | (14) −3.20 (1.96) |
Patient-recorded NRS score (all week) at week 8 | (11) −2.65 (2.81) | (10) −3.15 (2.66) | (12) −4.29 (2.33) |
Clinic-visit NRS score at week 1 | (14) −1.93 (1.73) | (14) −2.21 (3.19) | (14) −3.00 (2.60) |
Clinic-visit NRS score at week 4 | (13) −3.38 (2.69) | (11) −4.27 (2.94) | (14) −4.14 (2.18) |
Clinic-visit NRS score at week 8 | (13) −3.50 (2.71) | (11) −3.91 (2.66) | (12) −3.92 (2.35) |
Patient-recorded NRS score at day 2 | (16) −0.61 (1.29) | (12) −0.84 (1.24) | (13) −0.33 (0.74) |
Patient-recorded NRS score at day 3 | (14) −0.96 (0.99) | (11) −0.86 (1.64) | (13) −0.41 (0.65) |
Patient-recorded NRS score at day 4 | (14) −0.85 (1.09) | (12) −1.04 (1.88) | (14) −0.81 (1.28) |
Patient-recorded NRS score at day 5 | (13) −1.35 (1.12) | (12) −1.29 (2.23) | (13) −1.18 (1.45) |
Patient-recorded NRS score at day 6 | (14) −1.28 (1.68) | (11) −1.31 (2.20) | (11) −1.30 (1.54) |
Patient-recorded NRS score at day 7 | (14) −1.42 (2.30) | (12) −1.87 (3.63) | (13) −1.33 (1.89) |
Patient-recorded NRS score at day 8 | (14) −1.85 (2.31) | (11) −1.83 (2.42) | (14)−1.88 (2.03) |
Skindex-16 at week 1: symptoms | (14)−12.56 (22.25) | (13) 1.24 (25.05) | (13) −2.88 (18.50) |
Skindex-16 at week 4: symptoms | (13) −8.29 (25.06) | (11) −9.09 (36.94) | (13) −7.69 (29.56) |
Skindex-16 at week 8: symptoms | (12) −8.09 (23.60) | (11) −8.71 (36.19) | (12) −4.02 (33.30) |
Skindex-16 at week 1: emotions | (14) −44.73 (16.35) | (13) −21.52 (27.80) | (13) −21.29 (18.20) |
Skindex-16 at week 4: emotions | (13) −32.60 (24.96) | (11) −31.96 (36.34) | (13) −25.69 (26.54) |
Skindex-16 at week 8: emotions | (12) −35.37 (30.88) | (11) −37.23 (28.13) | (12) −36.86 (26.32) |
Skindex-16 at week 1: functioning | (14) −13.33 (16.69) | (13) −12.05 (29.08) | (13) −1.28 (13.51) |
Skindex-16 at week 4: functioning | (13) 2.05 (26.51) | (11) −11.51 (36.07) | (13) −1.80 (20.40) |
Skindex-16 at week 8: functioning | (12) −0.83 (28.04) | (11) −22.73 (25.64) | (12) −5.00 (16.17) |
LSEQ at week 1: getting to sleep | (13) −12.08 (22.10) | (12) −9.82 (23.50) | (12) −6.45 (16.97) |
LSEQ at week 4: getting to sleep | (12) −12.36 (19.61) | (9) 3.37 (23.64) | (12) −8.47 (18.19) |
LSEQ at week 8: getting to sleep | (11) −4.57 (13.67) | (9) 2.04 (25.47) | (11) −7.06 (23.68) |
LSEQ at week 1: quality of sleep | (13) −6.77 (26.98) | (12) −13.29 (33.39) | (12) −5.67 (15.39) |
LSEQ at week 4: quality of sleep | (12) −6.46 (20.63) | (9) −8.61 (39.09) | (12) −9.13 (17.60) |
LSEQ at week 8: quality of sleep | (11) −6.73 (21.81) | (9) −17.22 (34.00) | (11) −10.14 (26.73) |
LSEQ at week 1: awake following sleep | (13) 5.85 (19.80) | (12) −12.08 (32.39) | (12) −2.04 (15.50) |
LSEQ at week 4: awake following sleep | (12) 8.29 (16.22) | (8) −8.00 (43.83) | (12) −4.13 (19.93) |
LSEQ at week 8: awake following sleep | (11) 7.23 (16.91) | (9) −10.72 (36.14) | (11) −7.55 (30.06) |
LSEQ at week 1: behaviour following wakening | (13) 3.90 (12.44) | (12) −3.89 (32.06) | (12) −3.67 (7.67) |
LSEQ at week 4: behaviour following wakening | (12) 1.03 (15.97) | (9) 5.78 (46.41) | (12) −9.89 (14.53) |
LSEQ at week 8: behaviour following wakening | (11) −0.36 (13.73) | (9) 6.82 (49.17) | (11) −1.82 (19.95) |
Change from baseline, n (%) | |||
VRS score at week 1 | |||
Improved | 8 (57.1) | 9 (64.3) | 9 (64.3) |
No change | 5 (35.7) | 3 (21.4) | 4 (28.6) |
Worsened | 1 (7.1) | 2 (14.3) | 1 (7.1) |
VRS score at week 4 | |||
Improved | 10 (76.9) | 8 (80.0) | 11 (78.6) |
No change | 3 (23.1) | 2 (20.0) | 2 (14.3) |
Worsened | 0 | 0 | 1 (7.1) |
VRS score at week 8 | |||
Improved | 9 (75.0) | 9 (81.8) | 9 (81.8) |
No change | 3 (25.0) | 2 (18.2) | 2 (18.2) |
Worsened | 0 | 0 | 0 |
Change from week 4, (n) mean (SD) | |||
Patient-recorded NRS score (last three recordings) at week 5 | (13) −0.41 (1.409) | (10) −0.47 (1.989) | (14) −0.69 (0.991) |
Patient-recorded NRS score (last three recordings) at week 6 | (13) −0.46 (1.561) | (10) −0.83 (2.196) | (13) −0.69 (0.897) |
Patient-recorded NRS score (last three recordings) at week 7 | (12) 0.17 (1.972) | (10) 0.00 (3.604) | (12) −0.72 (1.127) |
Patient-recorded NRS score (last three recordings) at week 8 | (11) −0.42 (2.071) | (10) −0.33 (3.728) | (12) −0.92 (1.084) |
VRS score at week 8 | (12) −0.08 (1.730) | (11) 0.36 (3.501) | (12) 0.08 (1.165) |
Patients, n (% ) | |||
Prescribed rescue medication | 6 (37.5) | 4 (28.6) | 2 (14.3) |
Used rescue medication | 3 (18.8) | 2 (14.3) | 2 (14.3) |
EGFRI dose reduction | 3 (18.8) | 2 (14.3) | 2 (14.3) |
Withdrawal because of intense uncontrolled pruritus | 0 | 0 | 0 |
EGFRI, epidermal growth factor receptor inhibitor; LSEQ, Leeds Sleep Evaluation Questionnaire; NRS, numerical rating scale; VRS, verbal rating scale.