Table 2 Tolvaptan exposure and follow-up
Cohort 1 ≥ 2 on treatment, ≥ 2 post-treatment assessments | Cohort 2 ≥ 1 on treatment, ≥ 1 post-treatment assessments | ||||
|---|---|---|---|---|---|
Characteristic | Statistic or Category | eGFR Analysis (n = 20) | TKV Analysis (n = 11) | eGFR Analysis (n = 82) | TKV Analysis (n = 88) |
Prior exposure to tolvaptan | Yes | 0 | 0 | 4 (5%) | 16 (18%) |
No | 20 (100%) | 11 (100%) | 78 (95%) | 72 (82%) | |
Treatment duration, years | Mean (SD) | 2.2 (1.1) | 3.1 (0.3) | 2.8 (0.7) | 3.1 (0.7) |
Min, Max | 0.6, 3.9 | 2.8, 3.9 | 0.6, 4.4 | 1.0, 4.5 | |
Duration of post-tolvaptan follow-up, years | Mean (SD) | 3.6 (1.1) | 2.1 (0.5) | 1.5 (1.3) | 1.2 (0.8) |
Min, Max | 1.9, 5.1 | 1.3, 2.9 | 0.5, 5.1 | 0.5, 4.6 | |
Average daily tolvaptan dose, mg/daya | Mean (SD) | 81.6 (28.2) | 83.7 (25.6) | 97.4 (25.1) | 93.0 (26.1) |
Median | 73.7 | 80.6 | 112.6 | 101.1 | |
Q1, Q3 | 55.9, 118.4 | 60.3, 119.1 | 80.6, 119.1 | 62.2, 118.0 | |
Min, Max | 42.1, 119.3 | 54.7, 119.3 | 42.1, 119.6 | 42.1, 119.6 | |
Completion/termination status | Completed | 7 (35%) | 8 (73%) | 69 (84%) | 78 (89%) |
Discontinued treatment early | 13 (65%) | 3 (27%) | 13 (16%) | 10 (11%) | |
Reason for discontinuationb | Adverse events | 8 (62%) | 1 (33%) | 8 (62%) | 6 (60%) |
Subject met withdrawal criteria | 1 (8%) | 0 | 1 (8%) | 0 | |
Subject withdrew consent | 4 (31%) | 2 (67%) | 4 (31%) | 4 (40%) | |
Number of on-treatment eGFR assessments | Mean (SD) | 8 (3.5) | 10 (2.6) | ||
Median | 9 | 10 | |||
Q1, Q3 | 5, 10 | 9, 10 | |||
Min, Max | 2, 15 | 2, 16 | |||
Number of post-treatment eGFR assessments | Mean (SD) | 6 (2.2) | 4 (1.6) | ||
Median | 6 | 4 | |||
Q1, Q3 | 5, 7 | 4, 4 | |||
Min, Max | 2, 13 | 1, 13 | |||
Number of on-treatment TKV assessments | Mean (SD) | 3 (0.3) | 3 (1.6) | ||
Median | 3 | 3 | |||
Q1, Q3 | 3, 3 | 3, 3 | |||
Min, Max | 3, 4 | 1, 7 | |||
Number of post-treatment TKV assessments | Mean (SD) | 2 (0.4) | 1 (0.6) | ||
Median | 2 | 1 | |||
Q1, Q3 | 2, 2 | 1, 2 | |||
Min, Max | 2, 3 | 1, 3 | |||