Table 2.
Investigator-assessed treatment-emergent adverse events
| Parameter | Valuea |
|---|---|
| Treated patients | 111 |
| Total exposure (patient-days) | 77,369 |
| Exposure per patient (days) | |
| mean | 701 |
| median | 639 |
| Total AEs (all causes; n [%]) | 105 (94.6) |
| Total AEs leading to discontinuation or death (all causes; n [%]) | 30 (27.0) |
| AEs leading to discontinuation | 19 (17.1) |
| AEs leading to death before withdrawal | 11 (9.9) |
| Drug-related AEs (n [%]) | 52 (46.8) |
| most common drug-related AEsb | |
| pollakiuria | 11 (9.9) |
| thirst | 10 (9.0) |
| fatigue | 6 (5.4) |
| dry mouth | 4 (3.6) |
| polydipsia | 4 (3.6) |
| polyuria | 4 (3.6) |
| hypotension | 4 (3.6) |
| hypernatremia | 4 (3.6) |
| dizziness | 4 (3.6) |
| headache | 4 (3.6) |
| peripheral edema | 4 (3.6) |
| acute renal failure | 4 (3.6) |
| Drug-related AEs leading to discontinuation | 6 (5.4) |
| ventricular tachycardia | 1 (0.9) |
| irritability | 1 (0.9) |
| blood sodium increase | 1 (0.9) |
| anorexia | 1 (0.9) |
| blood creatinine increase | 1 (0.9) |
| pruritus | 1 (0.9) |
AEs that started during the tolvaptan treatment phase or were continuous from baseline and were serious; drug-related; or resulted in death, discontinuation, interruption, or reduction in tolvaptan dosage.
aPatients counted once per AE for the most severe of multiple occurrences.
bReported in >3% of patients.