Table 2—

Pneumonia in the safety population

PlaceboSAL 50 μgFP 500 μgSFC 50 μg/500 μg
Patients1544154215521546
Total treatment exposure yrs3278353135553700
AEs
 Patients139162224248
 Events170182300324
 Event rate per 1000 treatment-yrs52528488
SAEs
 Patients8699150157
 Events97105184204
 Event rate per 1000 treatment-yrs30305255
Fatal SAEs
 Patients10111512
Event rate per 1000 treatment-yrs3.13.14.23.2
Death on treatment#7 (0.5)9 (0.6)13 (0.8)8 (0.5)
  • Data are presented as n or n (%). SAL: salmeterol; FP: fluticasone propionate; SFC: SAL plus FP combination; AE: adverse event; SAE: serious adverse event. #: independent clinical end-points committee adjudicated primary cause of death up to 3 yrs.