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ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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Table 3<br />

Number (and percentage) of patients with drug-related adverse<br />

events (incidence ≥ 1% 1 ) (Safety Population)<br />

Adverse events<br />

Salmeterol<br />

xinafoate/fluticasone<br />

propionate MDI<br />

combination product<br />

Fluticasone<br />

propionate<br />

alone<br />

Salmeterol<br />

xinafoate alone<br />

Placebo<br />

Number of patients 622 614 274 176<br />

Any event 67 (11 %) 71 (11 %) 29 (11%) 9 (5%)<br />

Hoarseness/dysphonia 13 (2 %) 7 (1 %) 3 (2 %) 0 (0 %)<br />

Throat irritation 13 (2 %) 14 (2 %) 10 (4 %) 3 (2 %)<br />

Candidiasis of mouth and<br />

throat<br />

8 (1 %) 8 (1 %) 0 (0 %) 1 (

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