Table 1.
Patient Characteristics*
| Characteristic | Ventricular Arrhythmia or Cardiac Arrest (n = 1646) |
QTc Prolongation or Torsade de Pointes† (n = 379) |
|---|---|---|
| Mean age (SD), y‡ | 37.0 (14.0) | 44.0 (12.0) |
| Sex | ||
| Male | 574 (34.9) | 202 (53.3) |
| Female | 407 (24.7) | 155 (40.9) |
| Unspecified | 665 (40.4) | 22 (5.8) |
| Methadone as primary suspect§ | 678 (41.2) | 217 (57.3) |
| Median methadone dose (IQR), mg/d|| |
112.5 (45–270) | 150 (90–360) |
| Methadone indication | ||
| Pain | 52 (3.2) | 41 (10.8) |
| Opioid dependency | 107 (6.5) | 106 (28.0) |
| Outcome | ||
| Death | 1333 (80.9) | 42 (11.1) |
| Life-threatening outcome | 143 (8.6) | 118 (31.1) |
| Hospitalization | 254 (15.4) | 189 (49.9) |
| Disability | 4 (0.2) | 4 (1.1) |
| Required intervention | 40 (2.4) | 36 (9.5) |
IQR = interquartile range.
*
Values are numbers (percentages) unless otherwise indicated. Percentages may not sum to 100 due to rounding.
†
Term preferred in the Medical Dictionary for Regulatory Activities.
‡
Available data for 1546 patients with ventricular arrhythmia or cardiac arrest and 330 patients with QTc prolongation or torsade de pointes.
§
The U.S. Food and Drug Administration Adverse Event Reporting System defines "primary suspect" as the first drug that the initial reporter deemed most likely to be associated with the reactions.
||
Available data for 240 patients with ventricular arrhythmia or cardiac arrest and 208 patients with QTc prolongation or torsade de pointes.