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Table 3 Details on the three cases of atrioventricular block (AVB) with onset after the first dose of fingolimod

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

Gender, age (case number)

Event

CV medical history

Concomitant medications

CV baseline assessment

Onset of event, hours post dose

HR at onset (bpm)

Outcome

Action taken

Female, 24

Second degree AVB, M1

None

Topiramate

Normal ECG

3

54 (arrhythmic)

Spontaneously resolved within 12 hours

Patient was hospitalized

(Case 1)

HR: 67 bpm

BP: 100/60 mmHg

Male, 29

Second degree AVB, M1

Cardiac murmur

None

Abnormal ECGa

2

58

Spontaneously resolved within 12 hours

Patient was hospitalized. Study drug discontinued

(Case 2)

HR: 73 bpm

BP: 130/90 mmHg

Female, 29

First degree AVB

None

Trazodone

Normal ECG

4

68

Spontaneously resolved the day after

None

(Case 3)

HR: 72 bpm,

BP: 112/75 mmHg

  1. AVB: atrioventricular block, BP: blood pressure, bpm: beats per minute, CV: cardiovascular, ECG: electrocardiogram, HR: heart rate, M1: Mobitz type 1.
  2. aDeemed not clinically significant; slight delay in right AV activation.