Table 3.
Descriptions of Sicilian ADR reports related to TKIs for NSCLC collected into the RNF from January 2006 to December 2021.
| Suspected drug | Total | Seriousness | Gender | Age group | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Not serious (%) | Serious (%) | NA (%) | Male (%) | Female (%) | NA (%) | 18-65 yrs (%) | >65 yrs (%) | NA (%) | ||
| EGFRi | 238 | 177 (74.4) | 59 (24.8) | 2 (0.8) | 117 (49.2) | 119 (50.0) | 2 (0.8) | 86 (36.1) | 146 (61.4) | 6 (2.5) |
| AFT | 42 | 25 (59.5) | 15 (35.7) | 2 (4.8) | 29 (69.0) | 13 (31.0) | 13 (31.0) | 27 (64.3) | 2 (4.8) | |
| ERL | 138 | 110 (79.7) | 28 (20.3) | 49 (35.5) | 88 (63.8) | 1 (0.7) | 45 (32.6) | 91 (65.9) | 2 (1.4) | |
| GEF | 46 | 36 (78.3) | 10 (21.7) | 33 (71.7) | 12 (26.1) | 1 (2.2) | 20 (43.5) | 25 (54.3) | 1 (2.2) | |
| OSI | 12 | 6 (50.0) | 6 (50.0) | 6 (50.0) | 6 (50.0) | 8 (66.7) | 3 (25.0) | 1 (8.3) | ||
| ALKi | 20 | 11 (55.0) | 8 (40.0) | 1 (5.0) | 5 (25.0) | 15 (75.0) | 13 (65.0) | 5 (25.0) | 2 (10.0) | |
| ALEC | 1 | 1 (100) | 1 (100) | 1 (100) | ||||||
| CER | 3 | 2 (66.7) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 3 (100) | ||||
| CRIZ | 16 | 8 (50.0) | 7 (43.8) | 1 (6.3) | 4 (25.0) | 12 (75.0) | 9 (56.3) | 5 (31.3) | 2 (12.5) | |
| VEGFi | ||||||||||
| NTB | 5 | 4 (80.0) | 1 (20.0) | 1 (20.0) | 4 (80.0) | 4 (80.0) | 1 (20.0) | |||
| Total | 263 | 192 (73.0) | 68 (25.9) | 3 (1.1) | 123 (46.8) | 138 (52.5) | 2 (0.8) | 103 (39.2) | 152 (57.8) | 8 (3.0) |
Bold type intended as drug classes and total numebr of reports. ADR, adverse drug reaction; AFT, afatinib; ALEC, alectinib; ALKi, anaplastic lymphoma kinase inhibitors; CER, ceritinib; CRIZ, crizotinib; EGFRi, epidermal growth factor receptor inhibitors; ERL, erlotinib; GEF, gefitinib; NSCLC, non-small cell lung cancer; NTB, nintedanib; OSI, osimertinib; TKIs, tyrosine kinase inhibitors; VEGFi, vascular endothelial growth factor inhibitor; NA, not available; RNF, Rete Nazionale di Farmacovigilanza; yrs, years.