Table 4—

Details of all asthma-related deaths

Case no.Randomised treatmentStudy ref.Duration#daysDaily randomised treatment doseAge/sex/ raceDuration of randomised treatment daysTime in study until onset/death daysBaseline drug other than randomised treatment+Patient considered ICS-exposedCause of death
1FormSD-037-0345/ 181/308013659 μg Form + 160 μg Bud35/F/X241§237/247NPNPYesStatus asthmaticus; septic shock
2FormSD-039-0673/ 448/14883659/160 μg Form/Bud + Terb p.r.n.65/F/O299300/300NPNPYesAsthma
3FormSD-039-0735/ 110/761809/320 μg Form/Bud + Form/Bud p.r.n.55/M/C159ƒ166/198NPNPYesRespiratory failure
4FormSD-037-0699/ 26069/261384180Form p.r.n.56/F/C2##2/2SalmFlutYesAsthma
5FormSD-037-0699/ 45304/451773180Form p.r.n.43/F/O6969/69NRBDPYesAsthma
6FormSD-037-0699/ 45218/451990180Form p.r.n.44/M/O1515/15NRNRNoAsthma
7Non-LABASD-037-0699/ 45224/452193180Salb p.r.n.45/F/O9292/92NRNRNoAsthma
8Non-LABASD-037-0699/ 71029/710030180Salb p.r.n.18/M/C9191/91NRBDPYesAsthma
9FormSD-037-0003/ 34/34039018 μg Form13/M/C2627/28NPBDPYesRespiratory failure
10FormAD-039-0001/ 9199/9199011809/160 μg Form/Bud67/F/C2828/31NPNPYesAsthma
  • ICS: inhaled corticosteroids; LABA: long-acting β2-agonist; Form: formoterol; Bud: budesonide; F: female; X: other (i.e. other than Caucasian, Oriental or Black); Terb: terbutaline; O: Oriental; M: male; C: Caucasian; Salm: salmeterol; Flut: fluticasone; BDP: beclomethasone dipropionate; Salb: salbutamol; NR: none reported; NP: none permitted; p.r.n.: as needed. #: from clinical study protocol; : first day of randomised treatment to day of onset of event leading to death/day of death; +: taken in addition to study drug as maintenance therapy; §: patient developed pneumonia and septic shock during a hospital admission for asthma, the probable immediate cause of death was septic shock; ƒ: patient hospitalised for asthma, discontinued trial on day 159, remained at hospital and developed respiratory insufficiency that progressed into respiratory failure with fatal outcome; ##: patient randomised on day of severe asthma attack and took one dose of formoterol in the evening, death was pronounced the following evening.