Table V.

Parameter Estimates of PK/Efficacy Analysis and PK/Safety Analysis

(a) PK/efficacy analysis for spontaneous bowel movement (SBM) responder
Study No.	Parameter	Estimate		95% confidence interval
				Lower	Upper
1107 V9221 (Phase 2b)	a	−0.314		−0.797	0.159
	b	0.0191		−0.00801	0.0497
1314 V9231 and 1315 V9232 (Phase 3)	a	−0.537		−0.700	−0.375
	b	0.0194		0.0114	0.0274
(b) PK/safety analysis for gastrointestinal disorders
Study No.	Severity of Gastrointestinal Disorders	Parameter	Estimate	95% Confidence Interval
				Lower	Upper
1107 V9221 (Phase 2b)	Mild, Moderate, Severe	a	−1.76	−2.46	−1.16
		b	0.0310	0.00138	0.0617
	Moderate, Severe	a	−2.75	−3.84	−1.90
		b	0.0254	−0.0170	0.0615
1314 V9231 and 1315 V9232 (Phase 3)	Mild, Moderate, Severe	a	−1.72	−1.95	−1.51
		b	0.0106	0.000712	0.0202
	Moderate, Severe	a	−2.75	−3.09	−2.44
		b	0.0125	−0.00169	0.0259
	Severe	a	−4.39	−5.15	−3.77
		b	0.015	−0.0152	0.0409

^aProbability (SBM Responder) = 1 / [1 + exp. (− a - b × AUC_ss)]

^bProbability (Gastrointestinal Disorders) = 1 / [1 + exp. (− a - b × AUC_ss)]