Table 3. Improvement rate in frequency of bowel movement by subgroups.
Note: Improvement rate was calculated as the proportion of patients with improvement in frequency of bowel movement divided by total patients (improved, unchanged, or worsened).
| Category | 2 weeks | 4 weeks | 8 weeks | 12 weeks | |
| Improvement rate % (n/N) | Improvement rate % (n/N) | Improvement rate % (n/N) | Improvement rate % (n/N) | ||
| Total population | 75.0 (642/856) | 77.2 (461/597) | 76.2 (323/424) | 83.2 (228/274) | |
| Age (years) | <75 | 74.4 (395/531) | 78.3 (296/378) | 77.8 (210/270) | 82.5 (156/189) |
| ≥75 | 76.0 (247/325) | 75.3 (165/219) | 73.4 (113/154) | 84.7 (72/85) | |
| P-value | 0.5971 | 0.4052 | 0.3062 | 0.6572 | |
| Performance status | 0-2 | 74.8 (436/583) | 77.6 (330/425) | 77.6 (260/335) | 82.5 (188/228) |
| 3-4 | 75.4 (205/272) | 76.0 (130/171) | 70.5 (62/88) | 86.7 (39/45) | |
| P-value | 0.8548 | 0.6692 | 0.1611 | 0.4904 | |
| Severity of constipation before naldemedine dosing | Mild | 68.8 (132/192) | 71.6 (96/134) | 69.6 (80/115) | 78.5 (62/79) |
| Moderate | 77.3 (337/436) | 78.4 (239/305) | 81.1 (159/196) | 86.4 (102/118) | |
| Severe | 75.9 (173/228) | 79.7 (126/158) | 74.3 (84/113) | 83.1 (64/77) | |
| P-value | 0.0701 | 0.2050 | 0.0601 | 0.3419 | |
| Brain metastasis | No | 74.9 (599/800) | 77.6 (437/563) | 75.8 (304/401) | 83.1 (217/261) |
| Yes | 76.8 (43/56) | 70.6 (24/34) | 82.6 (19/23) | 84.6 (11/13) | |
| P-value | 0.7496 | 0.3425 | 0.4567 | 0.8897 | |
| Anticancer drug treatment | No | 76.0 (402/529) | 77.6 (266/343) | 77.1 (165/214) | 83.9 (115/137) |
| Yes | 73.4 (240/327) | 76.8 (195/254) | 75.2 (158/210) | 82.5 (113/137) | |
| P-value | 0.3937 | 0.8224 | 0.6522 | 0.7465 | |
| Opioid analgesics used when naldemedine was started | Fentanyl only | 63.6 (35/55) | 72.5 (29/40) | 82.1 (23/28) | 88.2 (15/17) |
| Only strong opioids other than fentanyl | 76.6 (480/627) | 77.6 (340/438) | 75.7 (237/313) | 82.7 (158/191) | |
| Weak opioids only | 69.5 (41/59) | 73.7 (28/38) | 71.4 (25/35) | 77.8 (21/27) | |
| Others | 74.8 (86/115) | 79.0 (64/81) | 79.2 (38/48) | 87.2 (34/39) | |
| P-value | 0.1354 | 0.8096 | 0.7394 | 0.7173 | |
| Previously used laxatives | Osmotic/saline laxatives only | 79.8 (269/337) | 80.9 (195/241) | 78.9 (138/175) | 83.2 (94/113) |
| Stimulant laxatives only | 72.0 (67/93) | 69.4 (43/62) | 71.4 (30/42) | 81.3 (26/32) | |
| Others | 75.9 (186/245) | 79.4 (139/175) | 80.5 (99/123) | 89.7 (70/78) | |
| Nothing | 66.3 (120/181) | 70.6 (84/119) | 66.7 (56/84) | 74.5 (38/51) | |
| P-value | 0.0073 | 0.0573 | 0.0835 | 0.1554 | |
| Concomitant laxatives | Osmotic/saline laxatives only | 78.1 (257/329) | 76.8 (182/237) | 76.6 (131/171) | 81.7 (89/109) |
| Stimulant laxatives only | 72.0 (59/82) | 68.5 (37/54) | 68.8 (22/32) | 81.0 (17/21) | |
| Others | 74.4 (244/328) | 79.2 (187/236) | 79.5 (140/176) | 86.2 (100/116) | |
| Nothing | 70.1 (82/117) | 78.6 (55/70) | 66.7 (30/45) | 78.6 (22/28) | |
| P-value | 0.2979 | 0.3967 | 0.2276 | 0.6954 | |