Table 5. Baseline characteristics of patients according to the effectiveness analysis set.
GI, gastrointestinal; OIC, opioid-induced constipation; SD, standard deviation.
| Baseline characteristic | Age, years | Weight, kg | Sex, male/female | Hospitalised | OIC present | Severity of constipation | Performance status | Liver failure | Renal failure | Non-cancer complications | History of GI disease | |||
| Mild | Moderate | Severe | 0-2 | 3-4 | ||||||||||
| Subgroup | Mean (SD) | Mean (SD) | n/n (%/%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) |
| Total population | 68.9 (12.9) | 53.5 (11.0) | 543/410 (57.0/43.0) | 656 (68.8) | 953 (100.0) | 211 (22.1) | 485 (50.9) | 257 (27.0) | 645 (67.7) | 307 (32.2) | 91 (9.5) | 56 (5.9) | 622 (65.3) | 182 (19.1) |
| Age (years) | ||||||||||||||
| <75 | 61.6 (10.6) | 54.9 (11.2) | 332/259 (56.2/43.8) | 406 (68.7) | 591 (100.0) | 141 (23.9) | 284 (48.1) | 166 (28.1) | 414 (70.1) | 177 (29.9) | 56 (9.5) | 32 (5.4) | 371 (62.8) | 99 (16.8) |
| ≥75 | 80.9 (4.5) | 51.1 (10.3) | 211/151 (58.3/41.7) | 250 (69.1) | 362 (100.0) | 70 (19.3) | 201 (55.5) | 91 (25.1) | 231 (63.8) | 130 (35.9) | 35 (9.7) | 24 (6.6) | 251 (69.3) | 83 (22.9) |
| Performance status | ||||||||||||||
| 0-2 | 67.9 (13.0) | 53.9 (11.1) | 375/270 (58.1/41.9) | 406 (62.9) | 645 (100.0) | 173 (26.8) | 322 (49.9) | 150 (23.3) | 645 (100.0) | 0 (0) | 58 (9.0) | 37 (5.7) | 401 (62.2) | 129 (20.0) |
| 3-4 | 70.9 (12.4) | 52.6 (10.9) | 167/140 (54.4/45.6) | 250 (81.4) | 307 (100.0) | 38 (12.4) | 162 (52.8) | 107 (34.9) | 0 (0) | 307 (100.0) | 33 (10.7) | 19 (6.2) | 221 (72.0) | 53 (17.3) |
| Severity of constipation before naldemedine dosing | ||||||||||||||
| Mild | 68.0 (13.0) | 54.3 (12.0) | 125/86 (59.2/40.8) | 143 (67.8) | 211 (100.0) | 211 (100.0) | 0 (0.0) | 0 (0.0) | 173 (82.0) | 38 (18.0) | 25 (11.8) | 7 (3.3) | 134 (63.5) | 36 (17.1) |
| Moderate | 69.5 (12.8) | 53.2 (10.2) | 268/217 (55.3/44.7) | 346 (71.3) | 485 (100.0) | 0 (0.0) | 485 (100.0) | 0 (0.0) | 322 (66.4) | 162 (33.4) | 47 (9.7) | 32 (6.6) | 328 (67.6) | 104 (21.4) |
| Severe | 68.5 (12.8) | 53.5 (11.6) | 150/107 (58.4/41.6) | 167 (65.0) | 257 (100.0) | 0 (0.0) | 0 (0.0) | 257 (100.0) | 150 (58.4) | 107 (41.6) | 19 (7.4) | 17 (6.6) | 160 (62.3) | 42 (16.3) |
| Brain metastasis | ||||||||||||||
| No | 69.3 (12.7) | 53.6 (11.1) | 506/383 (56.9/43.1) | 605 (68.1) | 889 (100.0) | 201 (22.6) | 449 (50.5) | 239 (26.9) | 611 (68.7) | 277 (31.2) | 88 (9.9) | 53 (6.0) | 578 (65.0) | 173 (19.5) |
| Yes | 63.0 (13.8) | 52.2 (9.6) | 37/27 (57.8/42.2) | 51 (79.7) | 64 (100.0) | 10 (15.6) | 36 (56.3) | 18 (28.1) | 34 (53.1) | 30 (46.9) | 3 (4.7) | 3 (4.7) | 44 (68.8) | 9 (14.1) |
| Anticancer drug treatment | ||||||||||||||
| No | 70.4 (12.4) | 52.3 (10.7) | 329/268 (55.1/44.9) | 406 (68.0) | 597 (100.0) | 122 (20.4) | 315 (52.8) | 160 (26.8) | 381 (63.8) | 215 (36.0) | 59 (9.9) | 34 (5.7) | 378 (63.3) | 112 (18.8) |
| Yes | 66.5 (13.3) | 55.4 (11.3) | 214/142 (60.1/39.9) | 250 (70.2) | 356 (100.0) | 89 (25.0) | 170 (47.8) | 97 (27.2) | 264 (74.2) | 92 (25.8) | 32 (9.0) | 22 (6.2) | 244 (68.5) | 70 (19.7) |
| Opioid analgesics used at naldemedine initiation | ||||||||||||||
| Fentanyl only | 67.3 (17.3) | 49.6 (9.4) | 36/28 (56.3/43.8) | 48 (75.0) | 64 (100.0) | 17 (26.6) | 27 (42.2) | 20 (31.3) | 39 (60.9) | 25 (39.1) | 7 (10.9) | 3 (4.7) | 41 (64.1) | 10 (15.6) |
| Only strong opioids other than fentanyl | 68.8 (12.4) | 53.7 (11.0) | 398/287 (58.1/41.9) | 480 (70.1) | 685 (100.0) | 151 (22.0) | 359 (52.4) | 175 (25.5) | 474 (69.2) | 210 (30.7) | 66 (9.6) | 35 (5.1) | 434 (63.4) | 122 (17.8) |
| Weak opioids only | 71.3 (13.1) | 55.5 (9.7) | 45/32 (58.4/41.6) | 50 (64.9) | 77 (100.0) | 18 (23.4) | 36 (46.8) | 23 (29.9) | 59 (76.6) | 18 (23.4) | 5 (6.5) | 5 (6.5) | 49 (63.6) | 22 (28.6) |
| Others | 68.9 (12.5) | 52.8 (12.6) | 64/63 (50.4/49.6) | 78 (61.4) | 127 (100.0) | 25 (19.7) | 63 (49.6) | 39 (30.7) | 73 (57.5) | 54 (42.5) | 13 (10.2) | 13 (10.2) | 98 (77.2) | 28 (22.0) |
| Previously used laxatives | ||||||||||||||
| Osmotic/saline laxatives only | 69.0 (12.9) | 53.7 (11.2) | 202/172 (54.0/46.0) | 245 (65.5) | 374 (100.0) | 88 (23.5) | 213 (57.0) | 73 (19.5) | 259 (69.3) | 115 (30.7) | 25 (6.7) | 18 (4.8) | 234 (62.6) | 62 (16.6) |
| Stimulant laxatives only | 69.8 (12.2) | 52.0 (10.5) | 53/51 (51.0/49.0) | 71 (68.3) | 104 (100.0) | 18 (17.3) | 65 (62.5) | 21 (20.2) | 69 (66.3) | 35 (33.7) | 9 (8.7) | 5 (4.8) | 72 (69.2) | 20 (19.2) |
| Others | 68.4 (12.8) | 53.6 (11.0) | 153/116 (56.9/43.1) | 202 (75.1) | 269 (100.0) | 46 (17.1) | 153 (56.9) | 70 (26.0) | 165 (61.3) | 104 (38.7) | 34 (12.6) | 18 (6.7) | 199 (74.0) | 67 (24.9) |
| Nothing | 69.0 (13.2) | 54.0 (11.1) | 135/71 (65.5/34.5) | 138 (67.0) | 206 (100.0) | 59 (28.6) | 54 (26.2) | 93 (45.1) | 152 (73.8) | 53 (25.7) | 23 (11.2) | 15 (7.3) | 117 (56.8) | 33 (16.0) |
| Concomitant laxatives | ||||||||||||||
| Osmotic/saline laxatives only | 69.4 (12.9) | 53.7 (11.3) | 196/168 (53.8/46.2) | 244 (67.0) | 364 (100.0) | 94 (25.8) | 196 (53.8) | 74 (20.3) | 255 (70.1) | 109 (29.9) | 21 (5.8) | 13 (3.6) | 216 (59.3) | 54 (14.8) |
| Stimulant laxatives only | 69.3 (12.7) | 52.2 (10.5) | 53/37 (58.9/41.1) | 65 (72.2) | 90 (100.0) | 18 (20.0) | 52 (57.8) | 20 (22.2) | 54 (60.0) | 36 (40.0) | 9 (10.0) | 5 (5.6) | 57 (63.3) | 14 (15.6) |
| Others | 68.2 (12.3) | 53.7 (10.8) | 209/148 (58.5/41.5) | 260 (72.8) | 357 (100.0) | 59 (16.5) | 197 (55.2) | 101 (28.3) | 236 (66.1) | 120 (33.6) | 45 (12.6) | 27 (7.6) | 269 (75.4) | 82 (23.0) |
| Nothing | 69.0 (14.1) | 53.5 (11.5) | 85/57 (59.9/40.1) | 87 (61.3) | 142 (100.0) | 40 (28.2) | 40 (28.2) | 62 (43.7) | 100 (70.4) | 42 (29.6) | 16 (11.3) | 11 (7.7) | 80 (56.3) | 32 (22.5) |