Table 4.
Summary of treatment-emergent adverse events
| Amiodarone Study | Edoxaban (N = 30) | Amiodarone (N = 29) | Amiodarone + Edoxaban (N = 28) | Overall (N = 30) |
|---|---|---|---|---|
| Subjects reporting ≥1 TEAE | 5 (16.7 %) | 7 (24.1 %) | 6 (21.4 %) | 14 (46.7 %) |
| Subjects reporting ≥1 treatment-related TEAE | 1 (3.4 %) | 2 (7.1 %) | 3 (10.0 %) | |
| Most frequentlya reported TEAEs | ||||
| Contact dermatitis | 0 | 2 (6.9%) | 1 (3.6 %) | 3 (10.0 %) |
| Diarrhea | 1 (3.3 %) | 0 | 1 (3.6 %) | 2 (6.7 %) |
| Pain in extremity | 1 (3.3 %) | 0 | 1 (3.6 %) | 2 (6.7 %) |
| Bleeding-related TEAEs | ||||
| Gingival bleeding | 0 | 0 | 1 (3.6 %) | 1 (3.3 %) |
| Menorrhagia | 0 | 0 | 1 (3.6 %) | 1 (3.3 %) |
| Fecal occult bleeding | 0 | 0 | 0 | 0 |
| Atorvastatin study | Edoxaban (N = 30) | Atorvastatin (N = 32) | Atorvastatin + Edoxaban (N = 29) | Overall (N = 32) |
|---|---|---|---|---|
| Subjects reporting ≥1 TEAE | 4 (13.3%) | 6 (18.8%) | 7 (24.1%) | 14 (43.8%) |
| Subjects reporting ≥1 treatment-related TEAE | 1 (3.3%) | 3 (9.4%) | 1 (3.4%) | 5 (15.6%) |
| All reported TEAEs | ||||
| Pharyngolaryngeal pain | 0 | 1 (3.1%) | 2 (6.3%) | 3 (9.4%) |
| Constipation | 0 | 2 (6.3%) | 0 | 2 (6.3%) |
| Cough | 1 (3.1%) | 1 (3.1%) | 0 | 2 (6.3%) |
| Nasal congestion | 0 | 1 (3.1%) | 1 (3.4%) | 2 (6.3%) |
| Bleeding-related TEAEs | ||||
| Dysmenorrhea | 1 (3.1%) | 0 | 0 | 0 |
| Fecal occult bleeding | 2 (6.3%) | 0 | 0 | 0 |
| Digoxin study | Digoxin (N = 24) | Digoxin + Edoxaban (N = 24) | Edoxaban (N = 24) | Edoxaban + Digoxin (N = 23) | Overall (N = 48) |
|---|---|---|---|---|---|
| Subjects reporting ≥1 TEAE | 8 (33.3 %) | 12 (50.0 %) | 19 (79.2 %) | 18 (78.3 %) | 25 (52.1 %) |
| Subjects reporting ≥1 treatment-related TEAE | 1 (4.2 %) | 3 (12.5 %) | 1 (4.2 %) | 0 | 5 (10.4 %) |
| Most frequentlya reported TEAEs | |||||
| Headache | 2 (8.3 %) | 5 (20.8 %) | 0 | 2 (8.7%) | 8 (16.7 %) |
| Dizziness | 0 | 2 (8.3 %) | 1 (4.2 %) | 2 (8.7%) | 5 (10.4 %) |
| Fecal occult bleeding | 3 (12.5 %) | 2 (8.3 %) | 1 (4.2 %) | 0 | 4 (8.3 %) |
| Nausea | 1 (4.2 %) | 1 (4.2 %) | 1 (4.2 %) | 0 | 3 (6.3 %) |
| Bleeding-related TEAEs | |||||
| Fecal occult bleeding | 3 (12.5 %) | 2 (8.3 %) | 1 (4.2 %) | 0 | 5 (10.4 %) |
| Dronedarone study | Edoxaban (N = 31) | Dronedarone (N = 34) | Dronedarone + Edoxaban (N = 34) | Overall (N = 34) |
|---|---|---|---|---|
| Subjects reporting ≥1 TEAE | 0 | 4 (11.8 %) | 7 (20.6 %) | 10 (29.4 %) |
| Subjects reporting ≥1 treatment-related TEAE | 0 | 1 (2.9 %) | 2 (5.9 %) | 3 (8.8 %) |
| Most frequentlya reported TEAEs | ||||
| Headache | 0 | 0 | 3 (8.8 %) | 3 (8.8 %) |
| Bleeding-related TEAEs | 0 | 0 | 0 | 0 |
| Quinidine study | Edoxaban (N = 37) | Edoxaban + Quinidine (N = 34) | Quinidine (N = 36) | Quinidine + Edoxaban (N = 33) | Overall (N = 42) |
|---|---|---|---|---|---|
| Subjects reporting ≥1 TEAE | 5 (13.5 %) | 9 (26.5 %) | 11 (30.6 %) | 12 (36.4 %) | 24 (57.1 %) |
| Subjects reporting ≥1 treatment-related TEAE | 3 (8.1 %) | 5 (14.7 %) | 4 (11.1 %) | 2 (6.1 %) | 10 (23.8 %) |
| Most frequentlya reported TEAEs | |||||
| Headache | 0 | 2 (5.9 %) | 3 (8.3 %) | 1 (3.0 %) | 5 (11.9 %) |
| Blood creatinine increased | 0 | 0 | 1 (2.8 %) | 3 (9.1 %) | 4 (9.5 %) |
| Nausea | 0 | 1 (2.9 %) | 2 (5.6 %) | 0 | 3 (7.1 %) |
| Fecal occult bleeding | 2 (5.4 %) | 0 | 0 | 1 (3.0 %) | 3 (7.1 %) |
| Chest pain | 1 (2.7 %) | 1 (2.9 %) | 0 | 2 (6.1 %) | 3 (7.1 %) |
| Bleeding-related TEAEs | |||||
| Fecal occult bleeding | 2 (5.4 %) | 0 | 0 | 1 (3.0 %) | 3 (7.1 %) |
| Epistaxis | 0 | 1 (2.9%) | 1 (2.8 %) | 0 | 2 (4.8 %) |
| Menorrhagia | 1 (2.7 %) | 1 (2.9%) | 0 | 0 | 2 (4.8 %) |
| Irregular menstruation | 1 (2.7 %) | 0 | 0 | 0 | 1 (2.4 %) |
| Hematochezia | 1 (2.7 %) | 0 | 0 | 0 | 1 (2.4 %) |
| Verapamil study | Edoxaban (N = 33) | Edoxaban + Verapamil (N = 32) | Verapamil (N = 33) | Verapamil + Edoxaban (N = 30) | Overall (N = 34) |
|---|---|---|---|---|---|
| Subjects reporting ≥1 TEAE | 4 (12.1 %) | 7 (21.9 %) | 13 (39.4 %) | 9 (30.0 %) | 22 (64.7 %) |
| Subjects reporting ≥1 treatment-related TEAE | 1 (3.0 %) | 0 | 9 (27.2 %) | 6 (20.0 %) | 15 (44.1 %) |
| Most frequentlyb reported TEAEs | |||||
| Headache | 0 | 1 (3.1 %) | 3 (9.1 %) | 3 (10.0 %) | 7 (20.6 %) |
| Constipation | 1 (3.0 %) | 1 (3.1 %) | 4 (12.1 %) | 2 (6.7 %) | 6 (17.6 %) |
| Occular hyperemia | 0 | 1 (3.1 %) | 1 (3.0 %) | 2 (6.7 %) | 4 (11.8 %) |
| Bleeding-related TEAEs | |||||
| Menorrhagia | 0 | 1 (3.1 %) | 1 (3.0 %) | 0 | 2 (5.9 %) |
| Fecal occult bleeding | 1 (3.0 %) | 0 | 0 | 0 | 1 (2.9 %) |
| Epistaxis | 0 | 0 | 0 | 1 (3.3 %) | 1 (2.9 %) |
All data represented as n (%). TEAE treatment-emergent adverse event
aReported in >6 % of overall subjects
bReported in >10 % of overall subjects