Table IV.
Spontaneous bowel movement responder in the PK/efficacy populationa | |||||
Study No. | Dose (mg) | Non_Responder | Responder | ||
1107 V9221 (Phase 2b) | 0 | 37 (60.7) | 24 (39.3) | ||
0.1 | 4 (44.4) | 5 (55.6) | |||
0.2 | 3 (33.3) | 6 (66.7) | |||
0.4 | 4 (40.0) | 6 (60.0) | |||
1314 V9231 and 1315 V9232 (Phase 3) | 0 | 361 (65.9) | 187 (34.1) | ||
0.2 | 208 (46.7) | 237 (53.3) | |||
Gastrointestinal disorders in the PK/safety populationb | |||||
Study No. | Dose (mg) | Not_Reported | Mild | Moderate | Severe |
1107 V9221 (Phase 2b) | 0 | 53 (86.9) | 6 (9.8) | 2 (3.3) | 0 (0.0) |
0.1 | 7 (77.8) | 1 (11.1) | 1 (11.1) | 0 (0.0) | |
0.2 | 5 (55.6) | 1 (11.1) | 3 (33.3) | 0 (0.0) | |
0.4 | 7 (70.0) | 2 (20.0) | 1 (10.0) | 0 (0.0) | |
1314 V9231 and 1315 V9232 (Phase 3) | 0 | 473 (86.3) | 47 (8.6) | 21 (3.8) | 7 (1.3) |
0.2 | 351 (78.9) | 52 (11.7) | 34 (7.6) | 8 (1.8) |
aCount (Percent)
bCount (Row percent)