Table 3.
Respiratory-related adverse effects grouped by category of interest
| Inhaled treprostinil (N = 666; 957.9 pt-yr) | Control (N = 667; 1093.7 pt-yr) | |||
|---|---|---|---|---|
| Event | Patients, no. (%)a | Events, no. (per pt-yr) | Patients, no. (%)a | Events, no. (per pt-yr) |
| Any event | 343 (52) | 867 (0.905)b | 338 (51) | 894 (0.817) |
| Evidence of bleeding from the upper or lower respiratory tract | 105 (16) | 148 (0.154)b | 93 (14) | 131 (0.120)b |
| Irritation or pain affecting the nose, mouth, larynx, or pharynx | 111 (17)b | 164 (0.171)b | 68 (10)b | 88 (0.080)b |
| Upper or lower respiratory tract infection | 246 (37) | 448 (0.468) | 270 (40) | 534 (0.488) |
| Wheezing, bronchospasm, or exacerbation of preexisting asthma or COPD | 79 (12) | 107 (0.112) | 89 (13) | 141 (0.129) |
Note
COPD: chronic obstructive pulmonary disease; pt-yr: patient-years of exposure.
a
Only unique patients were included in this analysis.
b
The 95% confidence interval on the ratio of frequencies or incidence rates excludes 1.00.