Table 4.
Bleeding-related or cardiac-related treatment-emergent adverse events.
| NSAID/APAP user | NSAID/APAP nonuser | |||||
|---|---|---|---|---|---|---|
| Duloxetine N = 137 n (%) |
Placebo N = 82 n (%) |
P value | Duloxetine N = 206 n (%) |
Placebo N = 156 n (%) |
P value | |
| Bleeding-related | ||||||
| Tendency to bruise | 1 (0.7) | 0 | .52 | 0 | 0 | — |
| Eye hemorrhage | 0 | 0 | — | 1 (0.5) | 1 (0.6) | .70 |
| Hemorrhagic cyst | 0 | 0 | — | 1 (0.5) | 0 | .31 |
| Rectal hemorrhage | 0 | 0 | — | 1 (0.5) | 0 | .44 |
| Cardiac-related | ||||||
| Palpitations | 5 (3.7) | 0 | .14 | 1 (0.5) | 1 (0.6) | .86 |
| Hypertension | 3 (2.2) | 1 (1.2) | .84 | 4 (1.9) | 2 (1.3) | .76 |
| Myocardial infarction | 1 (0.7) | 0 | .52 | 0 | 1 (0.6) | .32 |
| Tachycardia | 1 (0.7) | 0 | .29 | 2 (1.0) | 0 | .15 |
| Transient ischemic attack | 1 (0.7) | 0 | .52 | 1 (0.5) | 0 | .31 |
| Heart rate increased | 0 | 0 | — | 1 (0.5) | 0 | .44 |
| Hypertensive crisis | 0 | 0 | — | 1 (0.5) | 0 | .44 |
| Carotid artery stenosis | 1 (0.7) | 0 | .52 | 0 | 0 | — |
Abbreviation: APAP, acetaminophen; NSAID, nonsteroidal anti-inflammatory drugs.