TABLE 3.
Summary of treatment-emergent adverse events (AEs) during the base period
| Placebo (n=41) | MK-5475 32 µg (n=42) | MK-5475 100 µg (n=44) | MK-5475 380 µg (n=41) | |
|---|---|---|---|---|
| One or more AE# | 27 (65.9) | 28 (66.7) | 28 (63.6) | 27 (65.9) |
| Related¶ to treatment | 8 (19.5) | 12 (28.6) | 8 (18.2) | 6 (14.6) |
| Leading to treatment discontinuation | 0 | 1 (2.4) | 0 | 0 |
| Serious AE+ | 5 (12.2) | 4 (9.5) | 3 (6.8) | 4 (9.8) |
| Related¶ to treatment | 0 | 0 | 0 | 0 |
| Leading to treatment discontinuation | 0 | 0 | 0 | 0 |
| Leading to death | 2 (4.9) | 0 | 1 (2.3) | 0 |
| AE of interest | 0 | 0 | 2 (4.5) | 0 |
| Symptomatic hypotension§ | 0 | 0 | 1 (2.3) | 0 |
| Pulmonary haemorrhage | 0 | 0 | 0 | 0 |
| Haemoptysis | 0 | 0 | 1 (2.3) | 0 |
| Drug-induced livery injury | 0 | 0 | 0 | 0 |
| Serious AE of interest | 0 | 0 | 0 | 0 |
Data are presented as n (%). #: AEs included events occurring during the base period and the 14-day post-treatment follow-up if participants did not continue into the extension period; ¶: determined by the investigator to be related to treatment; +: serious AEs included events occurring during the base period and all post-treatment follow-up if participants did not continue into the extension period; §: symptomatic hypotension is defined as a physical finding of systolic blood pressure <90 mmHg or systolic blood pressure decrease of >40 mmHg below the participant's baseline and accompanied by at least one symptom, such as presyncope, dizziness, mental status changes, etc., as reported by the participant or otherwise witnessed.