Backup Slides

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Backup Slides
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Rate of Exacerbations Requiring Antibiotics

• Placebo SAL FP Advair 500/50
• N 1524 1521 1534 1533
• All Exacerbations requiring
• Antibiotics
• Mean number per year 0.83 0.69 0.77 0.72
• Treatment vs placebo
• Ratio 0.832 0.925 0.863
• p-value lt0.001 0.076 lt0.001
• Exacerbations requiring
• Antibiotics alone
• Mean 0.32 0.31 0.39 0.37
• Treatment vs placebo
• Ratio 0.946 1.203 1.152
• p-value 0.354 0.002 0.015

NOTE Negative Binomial Analysis
Data on file, GlaxoSmithKline (SCO30003)
Table X7.2.014
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Comparison of Moderate/Severe Exacerbations and
Pneumonia
Placebo SAL FP Advair 500/50 N (ITT)
1524 1521 1534 1533 Moderate/Severe
Exacerbations Patients with events () 1057
(69) 1065 (70) 1055 (69) 1039 (68) Events / 1000
treatment years 1072 931 973 877
Placebo SAL FP Advair 500/50 N (Safety)
1544 1542 1552 1546 Pneumonia terms Patients
with AEs () 139 (9) 162 (11) 224 (14) 248
(16) Events / 1000 treatment years 52 52 84 88
Note Adverse events occurring on treatment
Data on file. GlaxoSmithKline (SCO30003).
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Time to First ICS LABA, LABA or ICS
Note analysis includes medications of interest
of at least 28 days duration Note Vertical bars
represent standard errors
Data on file, GlaxoSmithKline (SCO30003)