Table 2.

Proportions of patients with serum bicarbonate <22 mmol/L in the correction phase ITT populations of ZS-003 (n = 753), HARMONIZE (n = 258) and HARMONIZE-Global (n = 267); and the maintenance phase ITT populations of HARMONIZE (n = 237) and HARMONIZE-Global (n = 248)

ZS-003	Placebo	SZC 1.25 g TID	SZC 2.5 g TID	SZC 5 g TID	SZC 10 g TID
CP baseline
n	157	150	138	153	143
<22 mmol/L, n (%)	44 (28.0)	48 (32.0)	50 (36.2)	52 (34.0)	39 (27.3)
CP 48 h
n	154	147	132	149	139
<22 mmol/L, n (%)	43 (27.9)	45 (30.6)	46 (34.8)	33 (22.1)	23 (16.5)
Odds ratio (95% CI) versus PBO		1.14 (0.69–1.87)	1.38 (0.84–2.28)	0.73 (0.43–1.29)	0.51 (0.29–0.90)
P-valuea		0.615	0.249	0.289	0.025
HARMONIZE	Placebo	SZC 5 g QD	SZC 10 g QD	SZC 15 g QD	SZC 10 g TID
CP baseline
n					251
<22 mmol/L, n (%)					99 (39.4)
CP 48 h
n					250
<22 mmol/L, n (%)					56 (22.4)
MP Day 15
n	79	43	44	52
<22 mmol/L, n (%)	27 (34.2)	11 (25.6)	7 (15.9)	7 (13.5)
Odds ratio (95% CI) versus PBO		0.66 (0.29–1.52)	0.36 (0.14–0.93)	0.30 (0.12–0.75)
P-valuea		0.414	0.036	0.009
MP Day 29
n	72	37	37	42
<22 mmol/L, n (%)	19 (26.4)	10 (27.0)	8 (21.6)	2 (4.8)
Odds ratio (95% CI) versus PBO		1.03 (0.42–2.53)	0.77 (0.30–1.97)	0.14 (0.03–0.63)
P-valuea		1.000	0.646	0.005
HARMONIZE-Global	Placebo	SZC 5 g QD	SZC 10 g QD		SZC 10 g TID
CP baseline
n					265
<22 mmol/L, n (%)					233 (87.9)
CP 48 h
n					255
<22 mmol/L, n (%)					201 (78.8)
MP Day 15
n	48	89	92
<22 mmol/L, n (%)	43 (89.6)	76 (85.4)	64 (69.6)
Odds ratio (95% CI) versus PBO		0.68 (0.23–2.04)	0.27 (0.10–0.74)
P-valuea		0.601	0.011
MP Day 29
n	40	83	87
<22 mmol/L, n (%)	37 (92.5)	71 (85.5)	61 (70.1)
Odds ratio (95% CI) versus PBO		0.48 (0.13–1.81)	0.19 (0.05–0.67)
P-valuea		0.381	0.006

^aP-value derived from Fisher’s exact test.

PBO, placebo.