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Table 3 Summary of cardiac-related SAEs

From: Results from the 5-year, phase IV RENEW (Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis) study

SAE, n (%)

Overall

Treatment phase

Annual follow-up

 

(N = 509)

(n = 509)

phase (n = 250)

Any cardiac event

25a (4.9)

22 (4.3)

4 (1.6)

Reduced LVEF

14 (2.8)

12 (2.4)

2 (0.8)

Myocardial infarction

4 (0.8)

4 (0.8)

0

Cardiomyopathy

5 (1.0)

3 (0.6)

2 (0.8)

Congestive heart failure

2 (0.4)

2 (0.4)

0

Cardiorespiratory arrest

1 (0.2)

1 (0.2)

0

Mitral valve incompetence

1 (0.2)

1 (0.2)

0

Tachycardia

2 (0.4)

1 (0.2)

1 (0.4)

Ventricular hypokinesia

1 (0.2)

1 (0.2)

0

  1. LVEF=left ventricular ejection fraction; SAE=serious adverse event.
  2. aOne patient had an SAE in both the treatment and follow-up phase.