Patient Satisfaction/QOL Evaluation

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Efficacy “Japanese Long-term Administration Study”7,29

Patient satisfaction with bowel movements

The percentages of patient satisfaction with bowel movements for Score 1 (satisfied), 2 (somewhat satisfied), 3 (somewhat dissatisfied), and 4 (dissatisfied) were 1.8%, 5.6%, 33.3%, and 59.3%, respectively, at Week 2 of the observation period, 16.5%, 41.7%, 29.3%, and 12.5%, respectively, at Week 2 of the treatment period, and 41.9%, 45.3%, 11.6%, and 1.2% at Week 52.


Satisfaction with bowel movement
<Reference information> Satisfaction with bowel movement

QOL evaluation by JPAC-QOL score

The 4 subscales of JPAC-QOL (physical discomfort score, psychosocial discomfort score, worries/concerns score, and satisfaction score) and total score were examined. The subscale score and total score significantly decreased from the score at enrollment at all evaluation time points of Weeks 4, 12, 24, 36, and 52 of the treatment period (p < 0.0001 for all; one-sample t-test vs. the score at enrollment).

QOL as evaluated using the JPAC-QOL score
<Reference information> QOL as evaluated using the JPAC-QOL score
7)EA Pharma Co., Ltd.: In-house data (investigation of safety and efficacy of long-term administration in patients with chronic constipation) <Data submitted for review for approval>
29)Nakajima A, et al.:Lancet Gastroenterol Hepatol 2018;3(8):537-547
(The authors include those who have received an advisory fee from EA Pharma Co., Ltd.
This study was supported by EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd.)

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