Table 4.
Heart rate dynamics by subgroup within 6 h post-dose
| Number of patients | Pre-dose heart ratea (bpm) | Lowest post-dose heart ratea (bpm) | Maximum decline in heart ratea (bpm) | |
|---|---|---|---|---|
| n (%) | Mean (range) | Mean (range) | Mean (SD) | |
| Fingolimod, N = 3951 | ||||
| Overall population | ||||
| Overall population | 3951 (100.0) | 73.9 (45–132) | 62.1 (31–101) | 11.8 (8.47) |
| By time of lowest heart rate | ||||
| Patients with lowest heart rate at < 6 h | 3455 (87.4) | 73.8 (45–132) | 61.9 (31–101) | 11.9 (8.42) |
| Patients with lowest heart rate at 6 h | 496 (12.6) | 74.6 (48–114) | 63.5 (38–90) | 11.1 (8.76) |
| p-valueb | 0.0394 | |||
| By presence of bradycardia | ||||
| Patients with bradycardia | 31 (0.8) | 59.5 (46–80) | 41.6 (31–44) | 17.9 (8.30) |
| Patients without bradycardia | 3920 (99.2) | 74.0 (45–132) | 62.2 (45–101) | 11.7 (8.45) |
| p-valueb | 0.0001 | |||
| By presence of second-degree AV block | ||||
| Patients with second-degree AV block | 62 (1.6) | 75.0 (56–95) | 62.7 (42–83) | 12.2 (8.12) |
| Patients without second-degree AV block | 3889 (98.4) | 73.8 (45–132) | 62.1 (31–101) | 11.8 (8.48) |
| p-valueb | 0.691 | |||
aas measured by on-site study personnel
bStudents t-test