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Table 1 Overview and causality scores of the 10 cases of fatal adverse events considered to have a probable or possible relationship with alemtuzumab, identified in the European Medicines Agency database

From: Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis

Patient no

Gender

Cycle no

Adverse event

Time to symptoms

Death

Causality scoresa

Conclusion

1

F

1

Intracerebral hemorrhage

5 days

5 days

1

1

1

2

Probable

2

F

1

Listeria encephalitis

10 days

12 days

1

1

1

1

Probable

3

F

1

Septic shock, multiple organ failure

3 days

15 days

2

1

2

2

Probable

4

F

1

Septic shock, multiple organ failure

14 days

16 days

1

1

2

2

Probable

5

F

1

Pneumonia

16 days

22 days

2

1

2

2

Probable

6

F

1

Neutropenia, Staphylococcus aureus infection, septic shock

27 days

28 days

1

1

1

2

Probable

7

F

1

Autoimmune hemolytic anemia, septic shock, DIC

8 months

8 months

1

1

1

1

Probable

8

M

2

Immune-mediated thrombocytopenia, brain stem hemorrhage

5 months

9 months

2

1

1

1

Probable

9

F

NR

Autoimmune hepatitis

15 months

16 months

2

2

1

2

Probable

10

F

2

Agranulocytosis, Clostridium colitis, Aspergillus pneumonia

17 months

18 months

2

1

3

3

Possible

  1. Cases are sorted after time from treatment to death
  2. DIC disseminated intravascular coagulation, VZV varicella zoster virus, NR not reported
  3. aCausality scores given by the four individual reviewers, using the following scale: 1: > 85% likelihood for causal relationship with alemtuzumab; 2: 85–50% likelihood; 3: 50–15% likelihood; 4: < 15% likelihood