Table 2 Most common all-cause AEs reported in ≥5% of patients
12-month icotinib (n = 84) | 6-month icotinib (n = 84) | Observation (n = 83) | ||||
|---|---|---|---|---|---|---|
All-cause AEs | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 |
Totala | 65 (77.4) | 7 (8.3) | 62 (73.8) | 5 (6.0) | 35 (42.2) | 2 (2.4) |
Rash | 31 (36.9) | 3 (3.6) | 32 (38.1) | 2 (2.4) | 1 (1.2) | 0 |
Diarrhea | 18 (21.4) | 1 (1.2) | 16 (19.0) | 1 (1.2) | 3 (3.6) | 0 |
Raised aminotransferases | 12 (14.3) | 1 (1.2) | 11 (13.1) | 0 | 4 (4.8) | 0 |
Leukopenia | 4 (4.8) | 1 (1.2) | 5 (6.0) | 0 | 7 (8.4) | 1 (1.2) |
Insomnia | 6 (7.1) | 1 (1.2) | 4 (4.8) | 1 (1.2) | 7 (8.4) | 0 |
Fatigue | 5 (6.0) | 0 | 4 (4.8) | 1 (1.2) | 3 (3.6) | 1 (1.2) |
Decreased appetite | 4 (4.8) | 0 | 5 (6.0) | 0 | 2 (2.4) | 0 |
Oral ulcers | 5 (6.0) | 0 | 3 (3.6) | 0 | 1 (1.2) | 0 |