Responder rate of SBM during 12 weeks
Time frame · During 12 weeks
Registry description
SBM: Spontaneous Bowel Movement
Responder rate of Abnormal bowel habits improvement during 12 weeks
Time frame · During 12 weeks
Responder rate of Abdominal pain/discomfort relief during 12 weeks
Time frame · During 12 weeks
Weekly responder rate of Global assessment of relief of IBS symptoms
Time frame · Up to 52 weeks
Registry description
The weekly responder of the evaluation items shall be the subject satisfying the followings at the time of evaluation in each week.Score of Global assessment of relief of IBS symptoms (7 scores: 1-7) is 1 or 2
Weekly responder rate of CSBM
Time frame · Up to 52 weeks
Registry description
Weekly responder of CSBM: The weekly mean value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period
Weekly responder rate of SBM
Time frame · Up to 52 weeks
Registry description
Weekly responder of SBM: The weekly mean value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period
Weekly responder rate of Abnormal bowel habits improvement
Time frame · Up to 52 weeks
Registry description
Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2
Weekly responder rate of Abdominal pain/discomfort relief
Time frame · Up to 52 weeks
Registry description
Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.
Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity.
Time frame · From baseline to every week until 52 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame · Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52
Registry description
IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version
Percentage of subjects with SBM within 24 hours after start of the initial administration
Time frame · Up to 24 hours
Percentage of subjects with CSBM within 24 hours after start of the initial administration
Time frame · Up to 24 hours
Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests
Time frame · Up to 52 weeks