Table 4.
Cardiovascular treatment-emergent adverse events reported for ≥1 % of patients in any treatment group in the cohort of patients with a listed medical history of hypertension and in the cohort of patients with at least one listed concomitant antihypertensive medication (safety population)
| System organ class Preferred term [n (%)] |
Listed medical history of hypertension | Listed concomitant antihypertensive medication | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 477) | Tapentadol ER (n = 489) | Oxycodone CR (n = 499) | Placebo (n = 446) | Tapentadol ER (n = 461) | Oxycodone CR (n = 469) | |
| Any cardiovascular TEAE | 29 (6.1) | 42 (8.6) | 56 (11.2) | 23 (5.2) | 39 (8.5) | 56 (11.9) |
| Cardiac disorders | 16 (3.4) | 18 (3.7) | 32 (6.4) | 11 (2.5) | 14 (3.0) | 33 (7.0) |
| Palpitations | 1 (0.2) | 2 (0.4) | 8 (1.6) | 1 (0.2) | 2 (0.4) | 10 (2.1) |
| Angina pectoris | 1 (0.2) | 0 | 5 (1.0) | 1 (0.2) | 0 | 6 (1.3) |
| Vascular disorders | 16 (3.4) | 26 (5.3) | 30 (6.0) | 14 (3.1) | 26 (5.6) | 29 (6.2) |
| Hypertension | 12 (2.5) | 12 (2.5) | 11 (2.2) | 11 (2.5) | 12 (2.6) | 11 (2.3) |
| Hot flush | 1 (0.2) | 9 (1.8) | 10 (2.0) | 1 (0.2) | 9 (2.0) | 9 (1.9) |
| Flushing | 1 (0.2) | 1 (0.2) | 4 (0.8) | 1 (0.2) | 1 (0.2) | 5 (1.1) |
CR controlled release, ER extended release, TEAE treatment-emergent adverse event