Table 5.
Respiratory-related adverse events reported in ≥5% of patients in either treatment group with a medical history of parenchymal lung disease
| Inhaled treprostinil (N = 420; 568.6 pt-yr) | Control (N = 403; 663.4 pt-yr) | |||
|---|---|---|---|---|
| Patients, no. (%) | Events, no. (per pt-yr) | Patients, no. (%) | Events, no. (per pt-yr) | |
| Any event | 265 (63) | 876 (1.541)a | 252 (63) | 899 (1.355)a |
| Cough | 80 (19) | 96 (0.169)a | 71 (18) | 80 (0.121)a |
| Upper respiratory tract infection | 63 (15) | 85 (0.149) | 77 (19) | 100 (0.151) |
| Epistaxis | 63 (15) | 84 (0.148)a | 50 (12) | 70 (0.106)a |
| Pneumonia | 43 (10) | 47 (0.083) | 40 (10) | 55 (0.083) |
| Bronchitis | 40 (10) | 53 (0.093) | 40 (10) | 52 (0.078) |
| Dyspnea | 37 (9) | 43 (0.076) | 51 (13) | 68 (0.103) |
| Wheezing | 35 (8) | 46 (0.081) | 42 (10) | 58 (0.087) |
| Sinusitis | 28 (7)a | 35 (0.062) | 45 (11)a | 51 (0.077) |
| Nasopharyngitis | 27 (6) | 32 (0.056) | 30 (7) | 41 (0.062) |
| Oropharyngeal pain | 24 (6) | 28 (0.049) | 18 (4) | 20 (0.030) |
| Throat irritation | 21 (5)a | 21 (0.037)a | 6 (1)a | 7 (0.011)a |
| COPD | 20 (5) | 27 (0.047)a | 11 (3) | 14 (0.021)a |
| Nasal congestion | 17 (4) | 20 (0.035) | 26 (6) | 26 (0.039) |
Note
Listed events use preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA), version 13.1. COPD: chronic obstructive pulmonary disease; pt-yr: patient-years of exposure.
a
The 95% confidence interval on the ratio of frequencies or incidence rates excludes 1.00.