Table 1.
Descriptions of Italian ADR reports related to TKIs for NSCLC collected into the RAM system from January 2006 to December 2021.
| Suspected drug | Total | Seriousness | Gender | Age group | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Not serious (%) | Serious (%) | NA (%) | Male (%) | Female (%) | NA (%) | <18 yrs (%) | 18-65 yrs (%) | >65 yrs (%) | NA (%) | ||
| EGFRi | 2,525 | 1,936 (76.7) | 563 (22.3) | 26 (1.0) | 1,206 (47.8) | 1,299 (51.4) | 20 (0.8) | 7 (0.3) | 914 (36.2) | 1,463 (57.9) | 141 (5.6) |
| AFT | 435 | 326 (74.9) | 104 (23.9) | 5 (1.1) | 126 (29.0) | 301 (69.2) | 8 (1.8) | 193 (44.4) | 211 (48.5) | 31 (7.1) | |
| ERL | 1,448 | 1,241 (85.7) | 192 (13.3) | 15 (1.0) | 893 (61.7) | 550 (38.0) | 5 (0.3) | 7 (0.5) | 494 (34.1) | 929 (64.2) | 18 (1.2) |
| GEF | 366 | 249 (68.0) | 111 (30.3) | 6 (1.6) | 97 (26.5) | 267 (73.0) | 2 (0.5) | 130 (35.5) | 214 (58.5) | 22 (6.0) | |
| OSI | 276 | 120 (43.5) | 156 (56.5) | 90 (32.6) | 181 (65.6) | 5 (1.8) | 97 (35.1) | 109 (39.5) | 70 (25.4) | ||
| ALKi | 486 | 246 (50.6) | 224 (46.1) | 16 (3.3) | 191 (39.3) | 280 (57.6) | 15 (3.1) | 294 (60.5) | 142 (29.2) | 50 (10.3) | |
| ALEC | 140 | 64 (45.7) | 76 (54.3) | 59 (42.1) | 78 (55.7) | 3 (2.1) | 82 (58.6) | 36 (25.7) | 22 (15.7) | ||
| BRG | 10 | 8 (80.0) | 2 (20.0) | 3 (30.0) | 7 (70.0) | 7 (70.0) | 2 (20.0) | 1 (10.0) | |||
| CER | 52 | 30 (57.7) | 19 (36.5) | 3 (5.8) | 19 (36.5) | 31 (59.6) | 2 (3.8) | 32 (61.5) | 16 (30.8) | 4 (7.7) | |
| CRIZ | 274 | 140 (51.1) | 121 (44.2) | 13 (4.7) | 104 (38.0) | 160 (58.4) | 10 (3.6) | 168 (61.3) | 84 (30.7) | 22 (8.0) | |
| LORL | 10 | 4 (40.0) | 6 (60.0) | 6 (60.0) | 4 (40.0) | 5 (50.0) | 4 (40.0) | 1 (10.0) | |||
| VEGFi | |||||||||||
| NTB | 37 | 10 (27.0) | 27 (73.0) | 24 (64.9) | 13 (35.1) | 20 (54.1) | 12 (32.4) | 5 (13.5) | |||
| Total | 3,048 | 2,192 (71.9) | 814 (26.7) | 42 (1.4) | 1,421 (46.6) | 1,592 (52.2) | 35 (1.2) | 7 (0.3) | 1,228 (40.3) | 1,617 (53.0) | 196 (6.4) |
Bold type intended as drug classes and total number of reports. ADR, adverse drug reaction; AFT, afatinib; ALEC, alectinib; ALKi, anaplastic lymphoma kinase inhibitors; BRG, brigatinib; CER, ceritinib; CRIZ, crizotinib; EGFRi, epidermal growth factor receptor inhibitors; ERL, erlotinib; GEF, gefitinib; LORL, lorlatinib; NSCLC, non-small cell lung cancer; NTB, nintedanib; OSI, osimertinib; TKIs, tyrosine kinase inhibitors; VEGFi, vascular endothelial growth factor inhibitor; NA, not available; RAM, Reazioni Avverse dei Medicinali; yrs, years.