Table 4.
Grade 3 or higher adverse events reported during treatment of EGFRm+ mNSCLC
| Total | |
|---|---|
| AEs (Grade ≥ 3) during first-line treatmenta, n (%) | (N = 162) |
| Any Grade ≥ 3 | 98 (60.5) |
| Thrombocytopenia | 35 (21.6) |
| Diarrhoea | 32 (19.8) |
| Decreased appetite | 30 (18.5) |
| Dermatitis acneiform | 29 (17.9) |
| Paronychia | 25 (15.4) |
| Fatigue | 19 (11.7) |
| Alopecia | 18 (11.1) |
| Asthenia | 17 (10.5) |
| Dry skin | 14 (8.6) |
| Mucositis | 11 (6.8) |
| Nausea | 9 (5.6) |
| Anaemia | 8 (4.9) |
| Increased ALT | 7 (4.3) |
| Pneumonitis | 7 (4.3) |
| Increased AST | 6 (3.7) |
| Leukopenia | 6 (3.7) |
| Neutropenia | 6 (3.7) |
| Dyspnoea | 4 (2.5) |
| Febrile neutropenia | 3 (1.9) |
| Pneumonia | 3 (1.9) |
| Vomiting | 2 (1.2) |
| Pleural effusion | 1 (0.6) |
| Prolonged QT interval on ECG | 1 (0.6) |
| Pyrexia | 1 (0.6) |
| Rash | 1 (0.6) |
| AEs (Grade ≥ 3) during second-line treatmenta, n (%) | (N = 58) |
| Any Grade ≥ 3 | 31 (53.4) |
| Fatigue | 12 (20.7) |
| Decreased appetite | 11 (19.0) |
| Diarrhoea | 7 (12.1) |
| Asthenia | 6 (10.3) |
| Dermatitis acneiform | 6 (10.3) |
| Pneumonitis | 4 (6.9) |
| Thrombocytopenia | 4 (6.9) |
| Increased ALT | 3 (5.2) |
| Anemia | 3 (5.2) |
| Dry skin | 3 (5.2) |
| Increased AST | 3 (5.2) |
| Mucositis | 3 (5.2) |
| Paronychia | 3 (5.2) |
| Alopecia | 2 (3.4) |
| Dyspnoea | 2 (3.4) |
| Anorexia | 1 (1.7) |
| Leukopenia | 1 (1.7) |
| Nausea | 1 (1.7) |
| Neutropenia | 1 (1.7) |
| Pneumonia | 1 (1.7) |
| Vomiting | 1 (1.7) |
AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, ECG electrocardiogram, N total number of subjects, n number of subjects per category
aList of selected relevant AEs reflects common Grade ≥ 3 AEs of EGFR-TKIs and chemotherapy based on published evidence (Wu 2014, Wu et al. 2017, Choi et al. 2018, Soria et al. 2018, Nakagawa et al. 2019, Nishio et al. 2019, Kim et al. 2019, Cho et al. 2020) and expert opinion