Table 3.
Incidence of AVBs on AECG recording: 6 h pre-treatment versus following administration of first dose of fingolimod 0.5 mg by subgroups and by type of AVB (safety set)
| Number of patients with eventsa (%) | No PCCs (n = 2,120) | PCCs (n = 295) | BBs/CCBs (n = 120) |
|---|---|---|---|
| Pre-treatment AECG | |||
| Mobitz type I second-degree AVB | 0 | 12 (4.1) | 0 |
| 2:1 AV block | 0 | 2 (0.7) | 0 |
| Post-dose AECG | |||
| Mobitz type I second-degree AVB | 18 (0.9) | 12 (4.1) | 0 |
| 2:1 AVB | 7 (0.3) | 6 (2.0) | 0 |
| Patients with events both pre-dose and post-dose | 0 | 6 (2.0) | 0 |
| Patients with new post-dose events | 19 (0.9) | 6 (2.0) | 0 |
Safety set includes all patients who received at least one dose of fingolimod
AECG ambulatory electrocardiogram, AVB atrioventricular block, BBs beta blockers, CCBs calcium channel blockers, PCCs pre-existing cardiac conditions or baseline cardiac findings
a Some individuals had two types of second-degree AVB (Mobitz type I and 2:1 AVB)