Table 6.
Adverse events during first-dose heart-rate monitoring
| Heart rate abnormalities | FIRST (n=2,415)44 | START (n=6,998)45 | PANGAEA (n=3,209)32 | |
|---|---|---|---|---|
| First-dose monitoring | Bradycardia (<45 bpm) | 15 (0.6%) | 63 (0.9%)a | 39 (1.22)c |
| First-degree AV block (PR >200 ms) | NA | 308 (4.5%)b | 7 (0.22%)c | |
| Second-degree AV block, Mobitz I | 30 (1.3%) | 117 (1.67%) | 19 (0.59%)c | |
| Second-degree AV block, Mobitz II | 0 | 0 | ||
| Type 2:1 AV block | 13 (0.5%) | 43 (0.61%) | NA | |
| QTc interval >500 ms | 0 | 0 | 3 (0.09%)c |
Notes:
a
Four were symptomatic;
b
123 (1.78%) patients had asymptomatic first-degree AV block on the ECG performed 1 week after initiating fingolimod treatment;
c
timing of these adverse events was not communicated.
Abbreviations: AV, atrioventricular; PR, pulse rate; NA, not available.