Table 3.

Estimated TKV (% of baseline) over time, by treatment cohort (matched analysis sets for TKV)

Matched analysis set	Time	Tolvaptan	Standard of care	Ratio, tolvaptan/standard of care (95% CI)	P value
Set A (102 subjects in each treatment group)	Yr 1	96.8	106.7	0.91 (0.89–0.93)	<0.001
	Yr 3	109.7	121.2	0.91 (0.88–0.93)	<0.001
	Yr 5	124.3	137.7	0.90 (0.86–0.95)	<0.001
Set B (182 subjects in each treatment group)	Yr 1	97.3	106.9	0.91 (0.89–0.93)	<0.001
	Yr 3	110.2	121.2	0.91 (0.89–0.93)	<0.001
	Yr 5	124.8	137.4	0.91 (0.88–0.94)	<0.001

TKV, total kidney volume.

Results were estimated from mixed models, which included treatment, time, time-by-treatment interaction, and baseline TKV as fixed effects and subject-specific intercept and slope (for time) as random effects with an unstructured variance-covariance matrix.