Table 5.
Detailed description of Sicilian SADR reports related to TKIs for NSCLC.
| Case | Type of seriousness | Age (years) | Sex | Suspected drug(s) (Therapeutic indication) | Concomitant drug(s) (Therapeutic indication) | ADR(s) | TTO (days) | Outcome | Causality assessment |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Hospitalization | 74 | M | ERL (NSCLC) | Gallopamil, dihydrocodeine | Rash | 4 | NA | Possible |
| 2 | Persistent or significant disability | 76 | F | ERL (NSCLC) | Acetylsalicylic acid, dexamethasone, omeprazole, lormetazepam | Skin ulcer | 110 | Fully recovered | Probable |
| 3 | Hospitalization | 44 | F | ERL (NSCLC) | – | Epidermolysis | 916 | Not yet recovered | Probable |
| 4 | Hospitalization | 54 | M | ERL (NSCLC) | – | Rash | 45 | Improved | Possible |
| 5 | Life-threatening | 66 | M | ERL (NSCLC) | – | Dyspnoea | 146 | Recovered with sequelae | Probable |
| 6 | Hospitalization | 51 | F | ERL (NSCLC) | Dexamethasone, furosemide, aciclovir, lansoprazole, enoxaparin | Hemoptysis, cough | 132 | Improved | Possible |
| 7 | Life-threatening | 67 | M | ERL (NSCLC) | – | Respiratory failure | 5 | Improved | Probable |
| 8 | Death | 63 | M | GEF (NSCLC) | – | Epilepsy, cerebral ischemia | 35 | Death after 49 days (ADR-related) | Possible |
| 9 | Death | 57 | M | ERL (NSCLC) | – | Respiratory failure, cardiogenic shock | 30 | Death after 7 days (unknown cause) | Possible |
| 10 | Hospitalization | 70 | M | ERL (NSCLC) | – | Respiratory failure, hyperpyrexia | 342 | Fully recovered | Possible |
| 11 | Hospitalization | 63 | F | GEF (NSCLC) | – | Cerebral haemorrhage | 64 | NA | Possible |
| 12 | Death | 37 | M | ERL (NSCLC III stage) | – | Interstitial lung disease | 71 | Death after 8 days (unknown cause) | Possible |
| 13 | Hospitalization | 75 | M | ERL (NSCLC) | Lansoprazole, amiodarone, clonidine | Ileus paralytic, hyperpyrexia, tachyarrhythmia | 41 | NA | Possible |
| 14 | Hospitalization | 48 | F | ERL (NSCLC) | Dexamethasone (dyspnoea), paracetamol (pain) | Neutropenia | 6 | Fully recovered | Possible |
| 15 | Hospitalization | 68 | M | GEF (NSCLC) | – | Diarrhea, asthenia, dehydration, weight decreased | 216 | Improved | Probable |
| 16 | Life-threatening | 65 | F | GEF (NSCLC) | – | Pulmonary embolism, renal infarct, hyperamylasemia | 63 | NA | Possible |
| 17 | Hospitalization | 63 | M | ERL (NSCLC) | – | Dyspnoea, hypertransaminasemia | 33 | Improved | Probable |
| 18 | Hospitalization | 58 | F | GEF (NSCLC) | – | Hypertransaminasemia | 0 | Improved | Probable |
| 19 | Hospitalization | 64 | F | GEF (NSCLC) | – | Coma, cellulitis, renal failure, hepatic failure | NA | Improved | Probable |
| 20 | Hospitalization | 67 | M | AFT (NSCLC) | – | Rash, acute myeloid leukaemia | 278 | Not yet recovered | Possible |
| 21 | Hospitalization | 74 | M | ERL (NSCLC) | – | Respiratory failure | 51 | Not yet recovered | Possible |
| 22 | Hospitalization | 81 | M | GEF (NSCLC IV stage) | – | Diarrhea | 7 | NA | Possible |
| 23 | Hospitalization | 65 | M | ERL (NSCLC) | – | Respiratory failure, pneumonia | 52 | NA | Probable |
| 24 | Hospitalization | 72 | M | ERL (NSCLC) | – | Pneumonia, neutropenia, leukopenia | 24 | Death after 26 days (unknown cause) | Possible |
| 25 | Hospitalization | 61 | M | CRIZ (NSCLC) | – | Cardiac failure | 42 | Improved | Probable |
| 26 | Death | 55 | F | OSI (NSCLC) | – | Rash, diarrhea, neutropenia, nail and nail bed conditions, neoplasm progression, general physical health deterioration | NA | Death (unknown cause) | Possible |
| 27 | Death | 48 | M | OSI (NSCLC IV stage) | – | Sudden death | NA | Death (unknown cause) | Possible |
| 28 | Hospitalization | 65 | F | ERL (NSCLC) | – | Leukopenia, pancytopenia, acute promyelocytic leukaemia | 1175 | Not yet recovered | Probable |
| 29 | Hospitalization | 53 | M | NTB + docetaxel (NSCLC IV stage) | Acetylsalicylic acid + bisoprolol (cardiac disorders), atorvastatin + omega-3-triglycerides (dyslipidemia), levetiracetam (epilepsy) | Gastrointestinal perforation | NA | Not yet recovered | Possible |
| 30 | Hospitalization | 70 | M | AFT (NSCLC) | – | Respiratory failure, pyrexia, interstitial lung disease | 504 | Improved | Probable |
| 31 | Hospitalization | 62 | F | CRIZ (NSCLC) | Levothyroxine sodium, furosemide, pantoprazole, and desloratadine | Hypertransaminasemia, pericardial effusion | NA | NA | Possible |
| 32 | Hospitalization | 69 | M | CRIZ + pembrolizumab (NSCLC IV stage) | Denosumab (NSCLC IV stage) | Hypertransaminasemia, rash, hepatitis | 65 | Improved | Highly probable |
| 33 | Hospitalization | 58 | F | OSI (NSCLC III stage) | – | Thrombotic stroke | 80 | NA | Possible |
SADR, serious adverse drug reaction; CRIZ, crizotinib; ERL, erlotinib; GEF, gefitinib; NA, not avilable; NSCLC, non-small cell lung cancer; NTB, nintedanib; OSI, osimertinib; TKIs, tyrosine kinase inhibitors; TTO, time to onset.