Table 4.
ICSRs sent to the Campania Pharmacovigilance Regional Centre from January 2001 to February 2019 reporting immune-related adverse drug reactions resulted in patient’s death.
| Case n. | Age (years) | Sex | Suspected drugs | Ther. Indic. | Concomitant drugs | ADR(s) | TTE (days) | TTD (days) | Causality Assessment |
|---|---|---|---|---|---|---|---|---|---|
| 1. | 78 | F | Ipilimumab | Mel. M. | – | Diarrhea, Thrombocytopenia | 65 | ~3 | Possible |
| 2. | 72 | M | Nivolumab | L.C. | – | Autoimmune hepatitis | 3 | 9 | Possible |
| 3. | 57 | F | Nivolumab | L.C. | Zoledronic Acid | Dyspnea, Peripheral edema |
10 | 6 | Possible |
| 4. | 66 | F | Nivolumab | L.C. | Metformin Levothyroxine Alprazolam Paroxetine Trazodone | Respiratory failure | 25 | 1 | Possible |
| 5. | 50 | M | Nivolumab | L.C. | – | Cardiac arrest | 18 | 18 | Possible |
| 6. | 70 | M | Nivolumab | Mel. | – | Pneumonia, death | N.A. | N.A. | Possible |
| 7. | 66 | F | Nivolumab | L.C. | Levothyroxine | AV block, eyelid ptosis, hypophysitis, myasthenia, diarrhea, and pneumonia | ~21 | ~210 | Possible |
| 8. | 67 | M | Nivolumab | L.C. | Acetylsalicylic acid | Hemoptysis | 15 | 7 | Possible |
Mel. M., metastatic melanoma; L.C., lung cancer; Mel., melanoma; AV block, atrioventricular block.