Skip to main content

Table 5 Clinical experience after one dose of fingolimod 0.5 mg/day in the present study (CFTY720DIT03) in comparison with a pooled analysis of three pivotal fingolimod phase III studies (2302, 2301, 2309 [6]) and the US EPOC study [14]

From: Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

n (%)

CFTY720DIT03

2302, 2301, 2309 [6]

EPOC [14]

n = 906

n = 1212a

n = 783

Discharged at 6 hours, did not return for monitoring

872 (96.2)

1006 (83.0%)

772 (98.6%)

Required extended monitoring after 6 hours

34 (3.8)

157 (12.9%)

10 (1.3%)

5 required 2 days of observation

2 required 2 days of observation

Required day 2 observation

10 (1.1)

32 (2.6)

3 (0.4)

Study drug discontinued

2 (0.2)

1 (0.1)

0 (0.0)

Symptomatic bradycardia

4 (0.4)

7 (0.6)

8 (1.0)

AVB, first degree

1b

56 (4.7)

15b

AVB, second degree

2b

2 (0.2)

0b

  1. AVB: atrioventricular block.
  2. aOnly patients treated with fingolimod 0.5 mg/day included.
  3. bThe frequency of AVB was not calculated since ECG was not performed routinely in all patients and the exact number of patients who underwent to ECG was not captured.