Case no. | Randomised treatment | Study ref. | Duration#days | Daily randomised treatment dose | Age/sex/ race | Duration of randomised treatment days | Time in study until onset/death¶ days | Baseline drug other than randomised treatment+ | Patient considered ICS-exposed | Cause of death | |
LABA | ICS | ||||||||||
1 | Form | SD-037-0345/ 181/30801 | 365 | 9 μg Form + 160 μg Bud | 35/F/X | 241§ | 237/247 | NP | NP | Yes | Status asthmaticus; septic shock |
2 | Form | SD-039-0673/ 448/1488 | 365 | 9/160 μg Form/Bud + Terb p.r.n. | 65/F/O | 299 | 300/300 | NP | NP | Yes | Asthma |
3 | Form | SD-039-0735/ 110/76 | 180 | 9/320 μg Form/Bud + Form/Bud p.r.n. | 55/M/C | 159ƒ | 166/198 | NP | NP | Yes | Respiratory failure |
4 | Form | SD-037-0699/ 26069/261384 | 180 | Form p.r.n. | 56/F/C | 2## | 2/2 | Salm | Flut | Yes | Asthma |
5 | Form | SD-037-0699/ 45304/451773 | 180 | Form p.r.n. | 43/F/O | 69 | 69/69 | NR | BDP | Yes | Asthma |
6 | Form | SD-037-0699/ 45218/451990 | 180 | Form p.r.n. | 44/M/O | 15 | 15/15 | NR | NR | No | Asthma |
7 | Non-LABA | SD-037-0699/ 45224/452193 | 180 | Salb p.r.n. | 45/F/O | 92 | 92/92 | NR | NR | No | Asthma |
8 | Non-LABA | SD-037-0699/ 71029/710030 | 180 | Salb p.r.n. | 18/M/C | 91 | 91/91 | NR | BDP | Yes | Asthma |
9 | Form | SD-037-0003/ 34/3403 | 90 | 18 μg Form | 13/M/C | 26 | 27/28 | NP | BDP | Yes | Respiratory failure |
10 | Form | AD-039-0001/ 9199/919901 | 180 | 9/160 μg Form/Bud | 67/F/C | 28 | 28/31 | NP | NP | Yes | Asthma |
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.