Overview of adverse events during tolvaptan treatment
| Subjects and Adverse Events | Prior Trial Participation | Total, n=1800, n (%)a | ||
|---|---|---|---|---|
| From Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease Tolvaptan, n=505, n (%) | From Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease Placebo, n=569, n (%) | From Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes 4:4 Tolvaptan, n=717, n (%) | ||
| Subjects with AEs | 473 (94) | 531 (93) | 643 (90) | 1656 (92) |
| AEs | 3567 | 4313 | 3963 | 11,932 |
| Subjects with treatment-emergent AEs | 473 (94) | 531 (93) | 640 (89) | 1653 (92) |
| Treatment-emergent AEs | 2965 | 3678 | 3297 | 10,019 |
| Subjects with serious treatment-emergent AEsb | 87 (17) | 96 (17) | 103 (14) | 289 (16) |
| Subjects with severe treatment-emergent AEsc | 74 (15) | 78 (14) | 83 (12) | 238 (13) |
| Subjects with treatment-emergent AEs both serious and severe | 43 (9) | 40 (7) | 44 (6) | 128 (7) |
| Subjects discontinued trial drug due to AEs | 33 (7) | 65 (11) | 38 (5) | 137 (8) |
| Deathsd | 1 (0.2) | 5 (0.9) | 3 (0.4) | 9 (0.5) |
AE, adverse event.
↵a The table has no column for subjects who entered the extension directly from the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 or NOCTURNE trial due to the small number of subjects (n=9; four from TEMPO 3:4 tolvaptan, two from NOCTURNE tolvaptan, and three from TEMPO 3:4 placebo) from those trials. Data from these subjects are included in the total column.
↵b Serious AEs were defined as those that resulted in any of the following outcomes: death; life-threatening risk in the opinion of the investigator; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; requires inpatient hospitalization or prolongs hospitalization; congenital anomaly/birth defect; or other medically significant events that, on the basis of appropriate medical judgment, may jeopardize the subject and may require medical or surgical intervention.
↵c AEs were graded as severe in cases resulting in an inability to work or perform normal daily activity.
↵d Causes were tuberculosis in a subject from the Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease (REPRISE) tolvaptan trial; aortic dissection/cardiogenic shock, CKD/septic shock, meningeal metastases, acute respiratory distress syndrome, and sudden death in subjects from REPRISE placebo; and cardiac arrest, subarachnoid hemorrhage, and ruptured cerebral aneurysm in subjects from TEMPO 4:4.