Table 4.

Summary of adverse events (AEs)^*

AEs	AZD1981, n (%)						Placebo (n=163)
	10 mg BID (n=163)	40 mg BID (n=163)	100 mg BID (n=164)	400 mg BID (n=164)	80 mg QD (n=164)	200 mg QD (n=159)
Any AE#	56 (34.4)	49 (30.1)	46 (28)	46 (28)	40 (24.4)	46 (28.9)	49 (30.1)
Serious AE	0	0	3 (1.8)	0	1 (0.6)	1 (0.6)	1 (0.6)
Drug AE§	2 (1.2)	4 (2.5)	5 (3)	3 (1.8)	4 (2.4)	2 (1.3)	4 (2.5)
Ten most common AEs
Nasopharyngitis	10 (6.1)	5 (3.1)	7 (4.3)	4 (2.4)	9 (5.5)	10 (6.3)	6 (3.7)
Headache	2 (1.2)	3 (1.8)	7 (4.3)	2 (1.2)	4 (2.4)	7 (4.4)	2 (1.2)
Bronchitis	5 (3.1)	5 (3.1)	2 (1.2)	1 (0.6)	1 (0.6)	4 (2.5)	5 (3.1)
Pharyngitis	3 (1.8)	3 (1.8)	4 (2.4)	2 (1.2)	4 (2.4)	2 (1.3)	1 (0.6)
Asthma	4 (2.5)	2 (1.2)	4 (2.4)	2 (1.2)	3 (1.8)	0	3 (1.8)
Influenza	5 (3.1)	3 (1.8)	0	1 (0.6)	2 (1.2)	0	4 (2.5)
Sinusitis	3 (1.8)	0	2 (1.2)	1 (0.6)	2 (1.2)	2 (1.3)	1 (0.6)
Nausea	1 (0.6)	2 (1.2)	0	3 (1.8)	1 (0.6)	2 (1.3)	0
Respiratory tract infection	5 (3.1)	1 (0.6)	1 (0.6)	1 (0.6)	0	1 (0.6)	2 (1.2)
Upper respiratory tract infection	1 (0.6)	2 (1.2)	0	2 (1.2)	2 (1.2)	2 (1.3)	2 (1.2)

Notes:

^*Based on safety-analysis set, which excluded the four patients who did not receive treatment, but included Good Clinical Practice violations;

^#patients who had at least one AE.

^§Leading to study-drug discontinuation.

Abbreviations: BID, twice daily; QD, once daily.