Table 1.
Subject demographic and baseline characteristics [FAS; mean (SD), unless otherwise specified]
| Parameter | COMPOSE-4 |
COMPOSE-5 |
|
|---|---|---|---|
| Naldemedine | Placebo | Naldemedine | |
| n = 97 | n = 96 | n = 131 | |
| Age, years | 63.8 (9.4) | 64.6 (11.8) | 63.5 (10.4) |
| Sex, n (%) | |||
| Male | 59 (60.8) | 60 (62.5) | 74 (56.5) |
| Female | 38 (39.2) | 36 (37.5) | 57 (43.5) |
| ECOG PS, n (%) | |||
| 0 | 28 (28.9) | 33 (34.0) | 43 (32.8) |
| 1 | 55 (58.8) | 49 (51.0) | 71 (54.2) |
| 2 | 14 (14.4) | 14 (14.6) | 17 (13.0) |
| Primary tumor, n (%) | |||
| Lung | 42 (43.3) | 45 (46.9) | 51 (38.9) |
| Breast | 22 (22.7) | 17 (17.7) | 29 (22.1) |
| Large intestine | 3 (3.1) | 3 (3.1) | 5 (3.8) |
| Other | 30 (30.9) | 31 (32.3) | 46 (35.1) |
| Daily dose of opioids,a mg | 57.3 (46.4) | 69.5 (99.5) | 64.0 (80.8) |
| Prior use, n (%) | |||
| Anticancer drugs | 72 (74.2) | 62 (64.6) | 93 (71.0) |
| Routine laxativesb | 72 (74.2) | 74 (77.1) | 98 (74.8) |
| Rescue laxativesc | 93 (95.9) | 89 (92.7) | 126 (96.2) |
| SBM frequency/week | 1.01 (0.76) | 1.10 (0.85) | 0.98 (0.80) |
| CSBM frequency/week | 0.52 (0.64) | 0.48 (0.67) | – |
| PAC-SYM scores | |||
| Overall | 1.06 (0.60) | 1.15 (0.62) | 1.13 (0.58) |
| Abdominal symptoms | 0.99 (0.67) | 1.07 (0.66) | 1.03 (0.64) |
| Rectal symptoms | 0.64 (0.73) | 0.64 (0.68) | 0.66 (0.68) |
| Stool symptoms | 1.38 (0.81) | 1.52 (0.89) | 1.48 (0.84) |
| PAC-QOL scores | |||
| Overall | 1.22 (0.51) | 1.31 (0.60) | 1.27 (0.54) |
| Physical discomfort | 1.08 (0.67) | 1.15 (0.69) | 1.13 (0.66) |
| Psychological discomfort | 0.55 (0.51) | 0.71 (0.63) | 0.66 (0.54) |
| Worries and concerns | 1.12 (0.68) | 1.20 (0.77) | 1.16 (0.73) |
| Dissatisfaction | 2.60 (0.73) | 2.63 (0.73) | 2.62 (0.72) |
a
Oral morphine-equivalents.
b
Subjects were routinely using laxatives at the start of the screening period.
c
Subjects who received rescue laxatives when needed.
CSBM, complete spontaneous bowel movement; ECOG PS, Eastern Cooperative Oncology Group performance status; FAS, full analysis set; PAC-QOL, Patient Assessment of Constipation-Quality of Life; PAC-SYM, Patient Assessment of Constipation-Symptoms; SBM, spontaneous bowel movement; SD, standard deviation.