. 2017 Jul 21;2(6):1132–1140. doi: 10.1016/j.ekir.2017.07.004

Table 2.

Subpopulation characteristics in TEMPO 4:4

Subgroup	n	Age, mean (SD), yr	Male, %	Baseline eGFR, mean (SD), ml/min per 1.73 m²	Baseline htTKV, mean (SD), ml/m	Baseline dasting uOsm, mean (SD), mOsm/kg	Time to first AAE report, median (IQR), d	Time to discontinuation, median (IQR), d
All prior placebo subjects	314	42.5 (7.2)	50	66.6 (25.4) n = 253	1196 (676) n = 289	442 (165) n = 309
Prior placebo without AAE	80	42.1 (8.0)	58	62.4 (24.4) n = 74	1286 (773) n = 72	429 (149) n = 77
Prior placebo with AAE	234	42.6 (6.9)	48	68.4 (25.6) n = 179	1167 (640) n = 217	446 (171) n = 232
Continued (AC)	182	43.3 (6.5)	47	67.5 (23.1)^a n = 135	1153 (615)^c n = 170	440 (169) n = 180	1 (1–2)
Discontinued (AD)	21	41.2 (8.1)	62	72.4 (30.5)^a^,^b n = 18	1145 (604)^c n = 18	445 (152)	1 (1–2)	196^d (49–910)
Polyuria	17	41.2 (7.8)	59	78.8 (27.2) n = 15	981 (474) n = 14	443 (148)
All other AAEs	4	41.0 (10.5)	75	40.4 (29.5) n = 3	1719 (729) n = 4	453 (191)
Discontinued Other AE (NAD)	31	44.3 (4.5)	48	51.9 (29.3)^b n = 25	1499 (910) n = 27	425 (132)	1 (1–2)	658^d (216–1218)

AAE, aquaretic adverse event, AC, aquaretic-continued; AD, aquaretic-discontinued; eGFR, estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; htTKV, height-adjusted total kidney volume; IQR, interquartile range; NAD, non–aquaretic-discontinued; TEMPO, Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes; uOsm, urine osmolality.

Data are presented on subjects who were on placebo in TEMPO 3:4 and switched to tolvaptan in TEMPO 4:4.

Subjects who discontinued for other reasons include the following: other AE (n = 17, 55%), completed (n = 11, 36%), investigator withdrew (n = 1, 3%), subject withdrew consent (n = 2, 6%).

P = 0.003.

P = 0.048.

P = 0.02.