Table 3.
Pulmonary, cardiovascular, allergic reaction and all-cause mortality secondary endpoints.
| Exubera N = 987 |
Usual Care N = 989 | |
|---|---|---|
| Pulmonary SAE Composite | ||
| Number of events adjudicated | 16 | 10 |
| Classification (%; CIa) | ||
| Met endpoint definitionb | 7 (0.7; 0.3–1.5) | 3 (0.3; 0.1–0.9) |
| Did not meet endpoint definition | 5 (0.5; 0.2–1.2) | 5 (0.5; 0.2–1.2) |
| Insufficient data | 4 (0.4; 0.1–1.0) | 2 (0.2; 0.0–0.7) |
| Cardiovascular SAE Composite | ||
| Number of events adjudicated | 46 | 40 |
| Classification (%; CIa) | ||
| Met endpoint definitionc | 12 (1.2; 0.6–2.1) | 11 (1.1; 0.6–2.0) |
| Did not meet endpoint definition | 25 (2.5; 1.6–3.7) | 22 (2.2; 1.4–3.3) |
| Insufficient data | 9 (0.9; 0.4–1.7) | 7 (0.7; 0.3–1.5) |
| Allergic Response SAE Composite | ||
| Number of events adjudicated | 6 | 1 |
| Classification (%; CIa) | ||
| Met endpoint definitiond | 2 (0.2; 0.0–0.7) | 0 (0.0; 0.0–0.4) |
| Did not meet endpoint definition | 1 (0.1; 0.0–0.6) | 1 (0.1; 0.0–0.6) |
| Insufficient data | 3 (0.3; 0.1–0.9) | 0 (0.0; 0.0–0.4) |
| All-Cause Mortality | ||
| Confirmed deathse | 12 (1.2; 0.6–2.1) | 9 (0.9; 0.4–1.7) |
COPD = chronic obstructive pulmonary disease, MI = myocardial infarction, N = number of subjects in the treatment group, SAE = serious adverse event.
95% confidence intervals on percentage based on Clopper-Pearson method.
Met endpoint definition = events classified as definite/possible pneumonia, definite/possible COPD, definite/possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis.
Met endpoint definition = events classified as definite/possible stroke, definite/possible MI, other (non-MI, non-stroke) cardiovascular/cerebrovascular death.
Met endpoint definition = events classified as anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction NOS.
Confirmed death by medical records or death certificate.