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
| 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 |
Cases are sorted after time from treatment to death
DIC disseminated intravascular coagulation, VZV varicella zoster virus, NR not reported
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