Table 2. Safety Dataa.
| Adverse event | No. (%) | |
|---|---|---|
| Balovaptan, 10 mg (n = 86) | Placebo (n = 81) | |
| Participants with ≥1 adverse event | 66 (76.7) | 61 (75.3) |
| Total No. of events | 339 | 188 |
| Participants with serious adverse events | 1 (1.2) | 4 (4.9) |
| Type of event | ||
| Suicidal ideation | 1 (1.2) | 0 (0.0) |
| Intentional self-injury | 0 (0.0) | 1 (1.2) |
| Aggression | 0 (0.0) | 1 (1.2) |
| Depression | 0 (0.0) | 1 (1.2) |
| Viral gastroenteritis | 0 (0.0) | 1 (1.2) |
| Deaths | 0 (0.0) | 0 (0.0) |
| Participants withdrawn from treatment owing to adverse events | 3 (3.5) | 4 (4.9) |
| Anxiety | 2 (2.3) | 0 (0.0) |
| Irritability | 1 (1.2) | 1 (1.2) |
| Troponin T increase | 0 (0.0) | 1 (1.2) |
| Weight increase | 0 (0.0) | 1 (1.2) |
| Headache | 0 (0.0) | 1 (1.2) |
| Most common adverse events (>5% in either group) | ||
| Nasopharyngitis | 21 (24.4) | 10 (12.3) |
| Influenza | 7 (8.1) | 5 (6.2) |
| Upper respiratory tract infection | 8 (9.3) | 4 (4.9) |
| Gastroenteritis | 5 (5.8) | 1 (1.2) |
| Headache | 14 (16.3) | 13 (16.0) |
| Diarrhea | 11 (12.8) | 4 (4.9) |
| Vomiting | 7 (8.1) | 6 (7.4) |
| Nausea | 5 (5.8) | 6 (7.4) |
| Abdominal discomfort | 6 (7.0) | 4 (4.9) |
| Abdominal pain upper | 6 (7.0) | 4 (4.9) |
| Oropharyngeal pain | 9 (10.5) | 6 (7.4) |
| Nasal congestion | 7 (8.1) | 4 (4.9) |
| Cough | 5 (5.8) | 5 (6.2) |
| Pyrexia | 6 (7.0) | 3 (3.7) |
| Irritability | 8 (9.3) | 4 (4.9) |
| Anxiety | 6 (7.0) | 1 (1.2) |
| Aggression | 5 (5.8) | 1 (1.2) |
| Decreased appetite | 5 (5.8) | 0 (0.0) |
a
No serious adverse events were considered related to the study treatment by the investigator, and all had resolved during the treatment period.