Table 4.
Respiratory-related adverse events reported in ≥5% of patients in either treatment group by baseline NYHA functional classification
| Inhaled treprostinil | Control | |||
|---|---|---|---|---|
| Event, NYHA FC | Patients, no. (%) | Events, no. (per pt-yr) | Patients, no. (%) | Events, no. (per pt-yr) |
| Any event | ||||
| 1 or 2 | 182 (63) | 573 (1.223) | 237 (59) | 768 (1.100) |
| 3 or 4 | 217 (59) | 699 (1.454) | 150 (57) | 526 (1.368) |
| Cough | ||||
| 1 or 2 | 52 (18) | 60 (0.128) | 65 (16) | 71 (0.102) |
| 3 or 4 | 69 (19) | 94 (0.196)a | 40 (15) | 47 (0.122)a |
| Upper respiratory tract infection | ||||
| 1 or 2 | 46 (16) | 63 (0.134) | 76 (19) | 106 (0.152) |
| 3 or 4 | 52 (14) | 65 (0.135) | 39 (15) | 52 (0.135) |
| Epistaxis | ||||
| 1 or 2 | 40 (14) | 55 (0.117) | 41 (10) | 59 (0.084) |
| 3 or 4 | 48 (13) | 61 (0.127) | 39 (15) | 50 (0.130) |
| Nasopharyngitis | ||||
| 1 or 2 | 23 (8) | 32 (0.068) | 37 (9) | 50 (0.072) |
| 3 or 4 | 21 (6) | 23 (0.048) | 11 (4) | 13 (0.034) |
| Pneumonia | ||||
| 1 or 2 | 23 (8) | 25 (0.053) | 30 (8) | 36 (0.052) |
| 3 or 4 | 32 (9) | 37 (0.077) | 24 (9) | 34 (0.088) |
| Wheezing | ||||
| 1 or 2 | 22 (8) | 28 (0.060) | 38 (10) | 52 (0.074) |
| 3 or 4 | 28 (8) | 34 (0.071) | 23 (9) | 29 (0.075) |
| Bronchitis | ||||
| 1 or 2 | 22 (8) | 30 (0.064) | 32 (8) | 43 (0.062) |
| 3 or 4 | 34 (9) | 44 (0.092) | 24 (9) | 30 (0.078) |
| Sinusitis | ||||
| 1 or 2 | 21 (7) | 28 (0.060) | 40 (10) | 49 (0.070) |
| 3 or 4 | 18 (5) | 22 (0.046) | 23 (9) | 24 (0.062) |
| Oropharyngeal pain | ||||
| 1 or 2 | 18 (6) | 20 (0.043) | 19 (5) | 21 (0.030) |
| 3 or 4 | 19 (5) | 23 (0.048) | 11 (4) | 11 (0.029) |
| Dyspnea | ||||
| 1 or 2 | 16 (5) | 17 (0.036)a | 37 (9) | 45 (0.064)a |
| 3 or 4 | 38 (10) | 45 (0.094) | 29 (11) | 40 (0.104) |
| Throat irritation | ||||
| 1 or 2 | 16 (5)a | 17 (0.036)a | 6 (2)a | 6 (0.009)a |
| 3 or 4 | 23 (6)a | 26 (0.054)a | 6 (2)a | 7 (0.018)a |
| Nasal congestion | ||||
| 1 or 2 | 11 (4) | 15 (0.032) | 19 (5) | 19 (0.027) |
| 3 or 4 | 15 (4) | 16 (0.033) | 18 (7) | 18 (0.047) |
Note
Listed events use preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA), version 13.1. NYHA FC: New York Heart Association functional class; pt-yr: patient-years of exposure.
a
The 95% confidence interval on the ratio of frequencies or incidence rates excludes 1.00.