Table 4.
Adverse events reported in Parts 1–3 of the study.
| AE (n (%)) |
Iloprost dose and nebulizer |
||
|---|---|---|---|
| Part 1 | 1.25 µg BREELIB (n = 11) | 2.5 µg BREELIB (n = 27) | Overall (n = 27) |
| Any AE | 3 (27) | 6 (22) | 9 (33) |
| Hypotension* | 2 (18) | 3 (11) | 5 (19) |
| Headache | 1 (9) | 1 (4) | 2 (7) |
| Angina pectoris | 0 | 1 (4) | 1 (4) |
| Cough | 0 | 1 (4) | 1 (4) |
| Dizziness | 0 | 1 (4) | 1 (4) |
| Hematoma | 0 | 1 (4) | 1 (4) |
| Nasopharyngitis | 0 | 1 (4) | 1 (4) |
| Part 2 |
5 µg I-Neb (n = 26) |
5 µg BREELIB (n = 27) |
Overall (n = 27) |
| Decrease in SBP ≥ 20% within 30 min of inhalation | 1 (4) | 4 (15) | 5 (19) |
| Increase in HR ≥ 25% within 30 min of inhalation | 0 (0) | 0 (0) | 0 (0) |
| Any AE | 3 (12)† | 4 (15)† | 6 (22)† |
| Hypotension* | 1 (4) | 4 (15) | 5 (19) |
| Cough | 1 (4) | 0 | 1 (4) |
| Dizziness | 0 | 1 (4) | 1 (4) |
| Feeling abnormal | 0 | 1 (4) | 1 (4) |
| Head discomfort | 0 | 1 (4) | 1 (4) |
| Hypertensive crisis | 1 (4) | 0 | 1 (4) |
| Part 3 |
5 µg I-Neb (n = 26) |
5 µg BREELIB (n = 27) |
Overall (n = 27) |
| Any AE | 7 (27)† | 14 (52)† | 14 (52)† |
| AEs occurring in > 4% of patients | |||
| Headache | 2 (8) | 4 (15) | 5 (19) |
| Cough | 0 | 3 (11) | 3 (11) |
| Atrioventricular block first degree | 0 | 2 (7) | 2 (7) |
| Hot flush | 0 | 2 (7) | 2 (7) |
| Palpitations | 0 | 2 (7) | 2 (7) |
| Respiratory tract infection | 1 (4) | 1 (4) | 2 (7) |
| Any serious AE | 2 (8)† | 2 (7)† | 4 (15)† |
| Pneumonia | 0 | 1 (4) | 1 (4) |
| Gastrointestinal hemorrhage | 0 | 1 (4) | 1 (4) |
| Syncope | 0 | 1 (4) | 1 (4) |
| Hyperglycemia | 1 (4) | 0 | 1 (4) |
| Hypokalemia | 1 (4) | 0 | 1 (4) |
| Diabetes mellitus | 1 (4) | 0 | 1 (4) |
| Colonoscopy | 1 (4) | 0 | 1 (4) |
*
Hypotension was pre-defined as SBP ≤ 90 mmHg, irrespective of hypotensive symptoms.
†
Patients can have experienced more than one AE.
AE, adverse event; HR, heart rate; SBP, systolic blood pressure.