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Table 2 Patient characteristics with potential relevance for cardiac events and frequency of symptoms by subgroup

From: Electrocardiographic assessments and cardiac events after fingolimod first dose – a comprehensive monitoring study

  Overall population Patients with bradycardia Patients with second-degree AV block Patients with AE Patients with symptoms suggestive of cardiac events at visit 2 Patients who discontinued study drug due to AE
N = 3951 N = 31 N = 62a N = 1350 N = 120 N = 38
Demographics
 Age (years), mean ± SD 39.3 ± 10.4 42.1 ± 10.9 40.4 ± 11.7 39.3 ± 10.4 39.6 ± 10.4 42.3 ± 12.4
 Female, n (%) 2779 (70.3) 14 (45.2) 57 (91.9) 1023 (75.8) 96 (80.0) 29 (76.3)
Concomitant medication known to prolong QT interval:
 SSRI n (%) 339 (10.1) 1 (3.2) 4 (6.5) 152 (11.3) 17 (14.2) 6 (15.8)
 TCA n (%) 92 (2.3) 0 0 38 (2.8) 2 (1.7) 1 (2.6)
 Amantadin n (%) 42 (1.1) 0 0 18 (1.3) 2 (1.7) 0
 Carbamazepin n (%) 29 (0.7) 0 1 (1.6) 14 (1.0) 3 (2.5) 1 (2.6)
 Fampridine n (%) 299 (7.6) 3 (9.7) 5 (8.1) 81 (6.0) 8 (6.7) 1 (2.6)
Heart rate at visit 2 pre-dose
 Heart rate (bpm), mean ± SD 73.9 ± 10.4 59.5 ± 8.0 75.0 ± 8.5 73.4 ± 10.4 73.3 ± 11.6 75.8 ± 10.6
Blood pressure at visit 2 pre-dose
 Systolic (mmHg), mean ± SD 121.8 ± 14.0 125.7 ± 20.3 117.5 ± 13.7 122.0 ± 14.1 123.9 ± 14.5 120.4 ± 15.4
 Diastolic (mmHg), mean ± SD 78.5 ± 9.7 78.1 ± 13.1 75.7 ± 9.0 78.7 ± 9.8 79.9 ± 10.0 76.1 ± 11.1
Potassium levels at visit 2
  < 3.5 mmol/L 13 (0.3) 0 0 5 (0.4) 0 0
  ≥ 3.5–5.5 mmol/L 3853 (98.3) 31 (100) 61 (98.4) 1320 (98.5) 119 (99.2) 38 (100.0)
  > 5.5 mmol/L 54 (1.4) 0 1 (1.6) 15 (1.1) 1 (0.8) 0
Symptoms suggestive of cardiac eventsb during 6 h first-dose observation
 Patients with symptoms, n (%) 120 (3.0) 1 (3.2)c 1 (1.6)d 120 (8.9) 120 (100.0) 1 (2.6)
  1. aOne of the patients had both, bradycardia and second-degree AV block and is therefore included in both groups
  2. bCardiac symptoms are defined as the following MedDRA preferred terms: Angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoe exertional, fatigue, palpitations, syncope, vertigo, vertigo positional, blurred vision
  3. cFatigue and chest discomfort
  4. dPalpitations