Table 5.

Composite secondary endpoint: time to clinical progression by recommendation in Irazabal et al.,¹⁶ and treatment group

Recommendation to exclude/include	Patients to exclude 1Aa/1B/2A/2Bb		Patients to include 1C/1D/1E
Treatment (no. of subjects)	PLC 48	TLV 103	PLC 433	TLV 851
ADPKD-related composite (no. of total events)	45	106	620	936
Events/100 person-yr	33.52	40.93	51.93	44.36
HR (95% CI)	1.20 (0.85, 1.71)		0.84 (0.75, 0.94)
P value	0.3028		0.0032
Treatment (no. of subjects)	PLC 47	TLV 97	PLC 427	TLV 813
Worsening kidney function (no. of total events)	1	2	63	41
Events/100 person-yr	0.75	0.77	5.3	1.95
HR (95% CI)	1.06 (0.10, 11.27)		0.37 (0.25, 0.55)
P value	0.9623		<0.0001
Treatment (no. of subjects)	PLC 48	TLV 103	PLC 433	TLV 851
Clinically significant kidney pain (no. of total events)	8	11	89	102
Events/100 person-yr	5.96	4.25	7.46	4.83
HR (95% CI)	0.71 (0.27, 1.83)		0.64 (0.46, 0.90)
P value	0.4745		0.0109
Treatment (no. of subjects)	PLC 48	TLV 103	PLC 433	TLV 851
Worsening hypertension (no. of total events)	30	72	396	658
Events/100 person-yr	22.35	27.80	33.17	31.19
HR (95% CI)	1.22 (0.78, 1.93)		0.92 (0.79, 1.08)
P value	0.3899		0.3077
Treatment (no. of subjects)	PLC 48	TLV 103	PLC 433	TLV 851
Worsening albuminuria (no. of total events)	7	23	96	170
Events/100 person-yr	5.21	8.88	8.04	8.06
HR (95% CI)	1.69 (0.79, 3.61)		0.99 (0.79, 1.23)
P value	0.1793		0.8965

ADPKD, autosomal dominant polycystic kidney disease; CI, confidence interval; HR, hazard ratio; PLC, placebo treatment group; TLV, tolvaptan treatment group. Significant results are highlighted in bold.

^aBecause of the entry criteria, none of the patients enrolled into TEMPO 3:4 were class 1A.

^bOnly 1 patient classified as 2B in this study.