Table 1.
Subpopulation characteristics in TEMPO 3:4
| Subgroup | n | Age, mean (SD), yr | Male, % | Baseline eGFR, mean (SD), ml/min per 1.73 m2 | Baseline htTKV, mean (SD), ml/m | Baseline fasting uOsm. mean (SD), mOsm/kg | Time to first AAE report, median (IQR), day | Time to discontinuation, median (IQR), day |
|---|---|---|---|---|---|---|---|---|
| All tolvaptan-treated subjects | 961 | 38.6 (7.1) | 52 | 81.3 (21.0) n = 958 |
979 (515) | 500 (173) n = 700 |
||
| Tolvaptan subjects without AAE | 211 | 38.4 (6.7) | 46 | 80.6 (20.6) | 1033 (563) | 511.7 (170) n = 147 |
||
| Tolvaptan subjects with AAE | 750 | 38.6 (7.2) | 53 | 81.6 (21.1) n = 747 |
963 (500) | 496 (173) n = 553 |
||
| Continued (AC) | 573 | 38.9 (7.1)a | 53 | 80.9 (20.9)f n = 675 |
957 (478) | 492 (176)k n = 504 |
2 (1–8) | |
| Discontinued AAE (AD) | 72 | 36.2 (7.8)a,b | 57c,d | 88.2 (22.2)e,f,g n = 72 |
915 (521)i,j | 544 (134)k n = 49 |
2 (1–6) | 96 (15–209)l,m |
| Polyuria | 40 | 36.4 (8.6) | 50 | 95.6 (18.6)h | 843 (385) | 555 (126) n = 27 |
||
| All other AAEs | 32 | 36.0 (7.0) | 66 | 79.0 (23.0)h | 1005 (648) | 531 (146) n = 22 |
||
| Discontinued other (NAD) | 105 | 38.3 (7.5) | 41d | 78.7 (21.6)g | 1032 (595)i | 490 (158) n = 76 |
1 (1–6) | 372 (121–631)m |
| All other AEs | 57 | 40.0 (7.1)b | 35c | 73.6 (19.2)e | 1046 (518)j | 486 (164) n = 42 |
1 (1–4) | 288 (121–577)l |
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 allocated to tolvaptan treatment.
Subjects who discontinued for reasons other than AAEs include other AE (n = 57, 54%), lost to follow-up (n = 11, 11%), subject met withdrawal criteria (n = 3, 3%), investigator withdrew subject (n = 2, 2%), subject withdrew consent (n = 32, 31%).
P = 0.006.
P = 0.007.
P = 0.02.
P < 0.05.
P = 0.006.
P = 0.0001.
P = 0.005.
P = 0.001.
P = 0.04.
P = 0.03.
P < 0.05.
P < 0.0001.
P < 0.0001.