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Table 6 Treatment-related SAEs during RENEW annual follow-up phase

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

SAE

Annual follow-up phase (n = 250)

 

Number of treatment-related events

 

Possible

Probable

Total

Decreased ejection fraction

0

2

2

Acute myeloid leukemia

0

1

1

Pneumonia

0

1

1

Anorexia

1

0

1

Cardiomyopathy

1

0

1

Tachycardia

1

0

1

Chronic myeloid leukemia

1

0

1

Endometrial cancer

1

0

1

Carotid artery occlusion

1

0

1

Cerebrovascular accident

1

0

1

Dyspnea

1

0

1

  1. SAE=serious adverse event; RENEW=Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis.