Table 3.
Adverse and treatment-emergent adverse events in TEMPO 4:4a
| Variable | Early-treatmentb(n = 557) | Delayed-treatmentb(n = 314) |
|---|---|---|
| TEAEs (%) | 92.6 | 96.5 |
| Serious TEAEs (%) | 16.0 | 17.5 |
| Subjects discontinued due to AEs (%) | 5.4 | 15.0 |
| TEAEs occurring in >10% of subjects in either rollover group, n (%) | ||
| Hypertension | 160 (28.7) | 83 (26.4) |
| Renal pain | 98 (17.6) | 60 (19.1) |
| Nasopharyngitis | 62 (11.1) | 38 (12.1) |
| Thirst | 260 (46.7) | 158 (50.3) |
| Polyuria | 229 (41.1) | 173 (55.1) |
| Polydipsia | 61 (11.0) | 51 (16.2) |
| Nocturia | 142 (25.5) | 107 (34.1) |
| Fatigue | 38 (6.8) | 44 (14.0) |
| Dry mouth | 45 (8.1) | 44 (14.0) |
| Dizziness | 18 (3.2) | 32 (10.2) |
| Headache | 58 (10.4) | 47 (15.0) |
| Deaths, n (%)c | 4 | 0 |
| ALT or AST >3× ULN, n (%) | 14 (2.5) | 12 (3.8) |
a
TEAEs and deaths reported within 24 months of first IMP of the open-label extension trial including those that discontinued drug.
b
The early-treatment group received tolvaptan in TEMPO 3:4 and delayed-treatment group received placebo.
c
Four deaths occurred within the first 24 months of the open-label extension trial; all deaths occurred after discontinuation of tolvaptan. Causes of death were cardiac arrest, gunshot wound, intracranial aneurysm and subarachnoid hemorrhage.