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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