Event | Gilenya@ Home (N = 5573) | Gilenya Assessment Network (N = 15,025) | Pooled RCTs [17] (n = 1212) | FIRST [18] (N = 2415) | EPOC [19] (N = 976) | START [20] (N = 3951)a | Italian open-label trial [21] (N = 906) | |
---|---|---|---|---|---|---|---|---|
No PCCs (n = 2120) | PCCs (n = 295) | |||||||
Heart rate | ||||||||
Maximum reduction, mean (SD), bpm | 10.6 (12.0) | 6.3 (9.6) | 8.1 (8.1) | 6.5 (NR) | 7.4 (NR) | 8.1 (8.3) | 11.8 (8.5) | NR |
Monitoring for more than 6 h | 557 (10.0) | 398 (2.6) | 157 (13.0) | 25 (2.6)b | 15 (5.5)b | 13 (1.3) | 333 (8.4) | 34 (3.8) |
New-onset conduction abnormalities | ||||||||
First-degree AV block | 132 (2.4) | 74 (0.5) | 56 (4.7)c | 0 | 0 | 16 (8.8)d | 206 (5.8) | 1 (0.1) |
Second-degree AV block | 4 (0.07) | 9 (0.1) | 2 (0.2)c | 25 (1.2) | 18 (6.1) | 2 (0.2)d | 78 (2.0) | 2 (0.2) |
Wenckebach (Mobitz type I) second-degree AV block | 3 (0.05) | NR | 2 (0.2)c | 18 (0.9) | 12 (4.1) | 2 (0.2)d | 60 (1.5) | 2 (0.2) |
2:1 s-degree AV block | 0 | NR | 0c | 7 (0.3) | 6 (2.0) | NR | 18 (0.5) | NR |
Mobitz type II second-degree AV block | 1 (0.02) | NR | 0c | 0 | 0 | 0d | 0 | NR |