Table 3.
Subjects with a >15% decrease in FEV1 from baseline to each post-baseline assessment
| Visit | Placebo n/N (%) |
Regadenoson n/N (%) |
Difference (regadenoson − placebo) [95% CI]a | P valueb |
|---|---|---|---|---|
| Asthma stratum | ||||
| Minute 5 | 1/161 (0.6) | 5/322 (1.6) | 0.9% [−0.9%, 2.8%] | .3941 |
| Minute 15 | 4/175 (2.3) | 2/355 (0.6) | −1.8% [−4.1%, 0.6%] | .0685 |
| Hour 1 | 1/86 (1.2) | 0/175 (0.0) | −1.1% [−3.2%, 1.0%] | .2032 |
| Hour 2c | 5/174 (2.9) | 4/351 (1.1) | −1.8% [−4.5%, 1.0%] | .1451 |
| Hour 8d | 2/23 (8.7) | 2/40 (5.0) | −3.9% [−17.5%, 9.7%] | .4151 |
| Follow-upe | 2/83 (2.4) | 3/173 (1.7) | −0.7% [−4.4%, 3.0%] | .7573 |
| At any visitf | 12/176 (6.8) | 13/356 (3.7) | −3.2% [−7.5%, 1.0%] | .1004 |
| COPD stratum | ||||
| Minute 5 | 4/132 (3.0) | 10/272 (3.7) | 0.7% [−3.0%, 4.4%] | .7315 |
| Minute 15 | 5/150 (3.3) | 9/314 (2.9) | −0.4% [−3.9%, 3.1%] | .8134 |
| Hour 1 | 1/13 (7.7) | 2/30 (6.7) | −8.7% [−25.8%, 8.4%] | .1138 |
| Hour 2c | 8/147 (5.4) | 13/313 (4.2) | −1.2% [−5.4%, 3.1%] | .5790 |
| Hour 8d | 4/14 (28.6) | 5/39 (12.8) | −20.7% [−48.4%, 7.1%] | .0971 |
| Follow-upe | 2/27 (7.4) | 4/58 (6.9) | −2.0% [−15.4%, 11.3%] | .7237 |
| At any visitf | 13/151 (8.6) | 31/316 (9.8) | 1.2% [−4.3%, 6.7%] | .6675 |
CI, confidence interval; COPD, chronic obstructive pulmonary disease; FEV 1 , forced expiratory volume in 1 second.
aTreatment effect and 95% confidence intervals were calculated using weighted averages where the weights adjusted for the number of subjects in each investigative site. These weights reflect their relative contribution to the Mantel-Haenszel statistic.
bCochran-Mantel-Haenszel test stratified by investigative site. Sites with <15 subjects were pooled.
cPrimary safety outcome.
dOnly includes subjects with FEV1 Hour 2 results not within 15% of baseline results or who were symptomatic at Hour 2.
eFollow-up: 24 hours post-drug administration; includes subjects with FEV1 Hour 2 results not within 15% of baseline results or who were symptomatic at Hour 2 and all subjects randomized under protocol amendment 3.
fFEV1 post-baseline assessments were performed at the Minute 5, Minute 15, Hour 1, Hour 2, Hour 8, and follow-up visit.