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. 2020 Feb 6;10(2):e030114. doi: 10.1136/bmjopen-2019-030114

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.