Table 7.
Parameter n (%) | Asthma stratum | COPD stratum | ||
---|---|---|---|---|
Placebo N = 176 |
Regadenoson N = 356 |
Placebo N = 151 |
Regadenoson N = 316 |
|
Within 2 hours of study drug administration | ||||
Subjects who experienced a respiratory symptomatic adverse event of interesta | 3 (1.7) | 42 (11.8) | 5 (3.3) | 58 (18.4) |
Subjects who used a short-acting bronchodilatorb | 3 (1.7) | 3 (0.8) | 5 (3.3) | 12 (3.8) |
Subjects using a short-acting bronchodilator at time of selected adverse eventc | 1 (0.6) | 1 (0.3) | 2 (1.3) | 2 (0.6) |
Within 24 hours of study drug administration | ||||
Subjects who experienced a respiratory symptomatic adverse event of interesta | 4 (2.3) | 46 (12.9) | 6 (4.0) | 60 (19.0) |
Subjects who used a short-acting bronchodilatorb | 94 (53.4) | 168 (47.2) | 65 (43.0) | 141 (44.6) |
Subjects using a short-acting bronchodilator at time of selected adverse eventc | 2 (1.1) | 5 (1.4) | 2 (1.3) | 5 (1.6) |
COPD, chronic obstructive pulmonary disease.
aDyspnea, wheezing, obstructive airways disorder, exertional dyspnea, and tachypnea (MedDRA version 11.1 preferred terms).
bShort-acting bronchodilators defined as medications coded to drugs for obstructive airway diseases.
cUse of a short-acting bronchodilator between the start and stop time of the specified respiratory adverse event of interest for each subject.