Table 6.

AEs observed in the study parts

Subject group and dose (mg)No. of subjectsNo. (%) of subjects with AETotal no. of AEsNo. of AEs per subjectNo. of AEs by typea
GINSRTIOther
Part A, single dose
    2531 (33)30.331101
    5060 (0)000000
    10062 (33)30.50102
    20065 (83)71.171402
    40061 (33)20.331100
    80065 (83)111.832108
    Placebo, single dose103 (33)50.50302
Part B, 7 days q.d.
    15064 (67)132.171318
    30060 (0)000000
    60063 (50)50.833101
    80065 (83)101.671117
    Placebo, multiple dose85 (63)121.51326
Part C
    Fasting subjects1411 (79)161.148215
    Fed subjects64 (67)101.675203
    Total group, 7 days q.d., 600 mg2015 (75)261.3013418
        Nonflatulence AE subjects11 (55)201.07418
  • a GI, gastrointestinal; NS, nervous system; RTI, respiratory tract infections; Other, cardiovascular, musculoskeletal, eye, skin, local reaction at puncture site, and/or general.