Table 2.
Before system launch |
After system launch |
|||||
---|---|---|---|---|---|---|
diTdP (n = 5) | SJS/TEN (n = 9) | Total (n = 14) | diTdP (n = 21) | SJS/TEN (n = 18) | Total (n = 39) | |
Age, y | 54 ± 19 | 60 ± 25 | 57 | 62 ± 17 | 56 ± 22 | 59 |
Female, % | 60 | 89 | 75 | 71 | 72 | 72 |
Unique drug classes implicated in ADEa | 2 | 6 | 8 | 10 | 6 | 16 |
Hours from event to consent (range) | 124 (75-197) | 44 (2-86) | 84 (2-197) | 76 (6-174) | 33 (0.5-108) | 55 (0.5-174) |
Recruited in unit unfamiliar with study | 1 (20) | 4 (44) | 5 (36) | 7 (33) | 7 (39) | 14 (36) |
Admitted for diagnosis unrelated to study | 2 (40) | 1 (11) | 3 (21) | 13 (41) | 1 (6) | 14 (36) |
Patients consented in event location | 4 | 9 | 13 | 12 | 17 | 29 |
Intubated before ADE | 0 | 6 | 6 | 5 | 3 | 8 |
QTc, ms | 537 ± 47 | – | – | 579 ± 58 | – | – |
Required ACLS | 2 (40) | – | – | 11 (52) | – | – |
Required pacemaker | 1 (20) | – | – | 4 (19) | – | – |
Involved BSA, % | – | 40 ± 29 | – | – | 33 ± 30 | – |
Required skin graft | – | 2 (22) | – | – | 5 (28) | – |
Values are mean ± SD or n (%), unless otherwise indicated.
ACLS: advanced cardiac life support; ADE: adverse drug event; BSA: body surface area; diTdP: drug-induced torsades de pointes; QTc: corrected QT interval; SJS: Stevens-Johnson syndrome; TEN: toxic epidermal necrolysis; ms: milliseconds.
RxNav Anatomical Therapeutic Chemical Class 1-4 from the National Library of Medicine.