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Summary of treatment-emergent adverse events.
| Tolvaptan (n = 11) | ||
|---|---|---|
| Number of events | n (%) | |
| Any TEAEs | 20 | 9 (81.8) |
| Mild | 15 | 7 (63.6) |
| Moderate | 4 | 3 (27.3) |
| Severe | 1 | 1 (9.1) |
| Drug-related TEAEs | 12 | 7 (63.6) |
| Mild | 9 | 5 (45.5) |
| Moderate | 3 | 3 (27.3) |
| Severe | 0 | 0 |
| Any SAEs | 0 | 0 |
| Any TEAEs reported in ≥ 2 patients, termed by PT | ||
| Thirst | 5 | 5 (45.5) |
| Pollakiuria | 4 | 4 (36.4) |
| Dry mouth | 3 | 3 (27.3) |
| Dyspnea | 2 | 2 (18.2) |
Abbreviations: PT, preferred term; SAE, serious adverse event; TEAE, treatment emergent adverse event.
