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Table 4 Heart rate dynamics by subgroup within 6 h post-dose

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

 

Number of patients

Pre-dose heart ratea (bpm)

Lowest post-dose heart ratea (bpm)

Maximum decline in heart ratea (bpm)

n (%)

Mean (range)

Mean (range)

Mean (SD)

 

Fingolimod, N = 3951

Overall population

 Overall population

3951 (100.0)

73.9 (45–132)

62.1 (31–101)

11.8 (8.47)

By time of lowest heart rate

 Patients with lowest heart rate at < 6 h

3455 (87.4)

73.8 (45–132)

61.9 (31–101)

11.9 (8.42)

 Patients with lowest heart rate at 6 h

496 (12.6)

74.6 (48–114)

63.5 (38–90)

11.1 (8.76)

p-valueb

   

0.0394

By presence of bradycardia

 Patients with bradycardia

31 (0.8)

59.5 (46–80)

41.6 (31–44)

17.9 (8.30)

 Patients without bradycardia

3920 (99.2)

74.0 (45–132)

62.2 (45–101)

11.7 (8.45)

p-valueb

   

0.0001

By presence of second-degree AV block

 Patients with second-degree AV block

62 (1.6)

75.0 (56–95)

62.7 (42–83)

12.2 (8.12)

 Patients without second-degree AV block

3889 (98.4)

73.8 (45–132)

62.1 (31–101)

11.8 (8.48)

p-valueb

   

0.691

  1. aas measured by on-site study personnel
  2. bStudents t-test