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. 2018 Oct 2;35(11):225. doi: 10.1007/s11095-018-2501-7

Table IV.

Frequency of Spontaneous Bowel Movement Responders and Gastrointestinal Disorders

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)