Table 4.
Summary of overall adverse events in the entire population and the Canadian subpopulation in two trials
| Entire population | Entire population | Canadian subpopulation | ||||
|---|---|---|---|---|---|---|
| 6 Amb a 1-U MK-3641 (n =385) | 12 Amb a 1-U MK-3641 (n =381) | PBO (n =386) | 6 Amb a 1-U MK-3641 (n =112) | 12 Amb a 1-U MK-3641 (n =110) | PBO (n =115) | |
| AE Category, n (%) | ||||||
| Any TEAEs | 296 (76.9) | 307 (80.6) | 264 (68.4) | 100 (89.3) | 104 (94.5) | 93 (80.9) |
| Any TRAEs | 213 (55.3) | 233 (61.2) | 98 (25.4) | 84 (75.0) | 89 (80.9) | 39 (33.9) |
| Any serious TEAEs | 5 (1.3) | 3 (0.8) | 4 (1.0) | 1 (0.9) | 0 | 1 (0.9) |
| Any serious TRAEs | 0 | 0 | 0 | 0 | 0 | 0 |
| Any TEAEs leading to study discontinuation | 31 (8.1) | 35 (9.2) | 9 (2.3) | 16 (14.3) | 15 (13.6) | 2 (1.7) |
| Any TRAEs leading to study discontinuation | 26 (6.8) | 31 (8.1) | 6 (1.6) | 14 (12.5) | 14 (12.7) | 1 (0.9) |
| TRAEs in ≥5% of subjects, n (%) | ||||||
| Oral pruritus | 83 (21.6) | 66 (17.3) | 10 (2.6) | 40 (35.7) | 36 (32.7) | 7 (6.1) |
| Ear pruritus | 54 (14.0) | 54 (14.2) | 6 (1.6) | 24 (21.4) | 30 (27.3) | 2 (1.7) |
| Throat irritation | 90 (23.4) | 96 (25.2) | 21 (5.4) | 39 (34.8) | 43 (39.1) | 9 (7.8) |
| Mouth edema | 38 (9.9) | 37 (9.7) | 2 (0.5) | 20 (17.9) | 17 (15.5) | 2 (1.7) |
| Eye pruritus | 16 (4.2) | 15 (3.9) | 5 (1.3) | 9 (8.0) | 5 (4.5) | 1 (0.9) |
| Nasal passage irritation | 14 (3.6) | 15 (3.9) | 14 (3.6) | 7 (6.3) | 5 (4.5) | 2 (1.7) |
| Skin pruritus | 24 (6.2) | 10 (2.6) | 6 (1.6) | 12 (10.7) | 3 (2.7) | 2 (1.7) |
AE, adverse event; PBO, placebo; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.