Table 7—

Event rates in additional subgroups

TrialFormoterolNo Formoterol
PatientsnFollow-up TPYDeathsnDeath rate per TTYPatients with SAEs# n (%)PatientsnFollow-up TPYDeathsnDeath rate per TTYPatients with SAEs# n (%)
No LABA comparator groups
 Asthma-related events2840912.720.16189 (0.67)
 Cardiac-related events2840912.710.0861 (0.21)
 Other deaths2840912.790.71
 Total deaths2840912.7120.94
RELIEF: overall results
 Asthma-related events89244.330.70106 (1.19)89384.320.47120 (1.34)
 Cardiac-related events89244.361.4020 (0.22)89384.371.6330 (0.38)
 Other deaths89244.340.9389384.320.47
 Total deaths89244.3133.0289384.3112.56
RELIEF: BL ICS use
 Asthma-related events58212.820.7281 (1.39)58032.810.3690 (1.55)
 Cardiac-related events58212.851.8013 (0.22)58032.841.4323 (0.40)
 Other deaths58212.831.0858032.810.36
 Total deaths58212.8103.6058032.862.15
RELIEF: no BL ICS use
 Asthma-related events31031.510.6725 (0.81)31351.510.6730 (0.96)
 Cardiac-related events31031.510.677 (0.23)31351.531.997 (0.22)
 Other deaths31031.510.6731351.510.67
 Total deaths31031.532.0331351.553.32
  • TPY: 1,000 person-yrs; TTY: 1,000 treatment-yrs; SAEs: serious adverse events; LABA: long-acting β2-agonist; RELIEF: Real life effectiveness of Oxis Turbuhaler as needed in asthmatic patients during 6-month trial; BL: baseline; ICS: inhaled corticosteroid. #: at least one nonfatal SAE per patient (defined using International Conference on Harmonisation recommendations).