Table 4 Adverse events related to afatinib
Adverse events | All patients | Afatinib 30 mg daily | Afatinib 40 mg daily | P value |
|---|---|---|---|---|
Presence of adverse events | ||||
Diarrhea | 31 (65%) | 12 (41%) | 19 (100%) | <0.0001 |
Moderate-to-severe (≥ Grade 2) | 3 (6%) | 1 (3%) | 2 (11%) | 0.3218 |
Stomatitis | 10 (21%) | 5 (17%) | 5 (26%) | 0.4490 |
Moderate-to-severe (≥ Grade 2) | 2 (4%) | 0 (0%) | 2 (11%) | 0.0743 |
Paronychia | 24 (50%) | 14 (48%) | 10 (53%) | 0.7679 |
Moderate-to-severe (≥ Grade 2) | 13 (27%) | 9 (31%) | 4 (21%) | 0.4466 |
Skin rash and/or acneiform eruption | 41 (85%) | 25 (86%) | 16 (84%) | 0.8480 |
Moderate-to-severe (≥ Grade 2) | 8 (17%) | 4 (14%) | 4 (21%) | 0.5093 |
Dry skin | 34 (71%) | 20 (69%) | 14 (74%) | 0.7250 |
Moderate-to-severe (≥ Grade 2) | 1 (2%) | 0 (0%) | 1 (5%) | 0.2118 |
Pruritus | 12 (25%) | 6 (21%) | 6 (32%) | 0.3942 |
Moderate-to-severe (≥ Grade 2) | 0 (0%) | 0 (0%) | 0 (0%) | |
Details of adverse events | ||||
Diarrhea | 0.0004 | |||
Grade 0 | 17 (35%) | 17 (59%) | 0 (0%) | |
Grade 1 | 28 (58%) | 11 (38%) | 17 (89%) | |
Grade 2 | 2 (4%) | 1 (3%) | 1 (5%) | |
Grade 3 | 1 (2%) | 0 (0%) | 1 (5%) | |
Stomatitis | 0.2033 | |||
Grade 0 | 38 (79%) | 24 (83%) | 14 (74%) | |
Grade 1 | 8 (17%) | 5 (17%) | 3 (16%) | |
Grade 2 | 2 (4%) | 0 (0%) | 2 (11%) | |
Paronychia | 0.1013 | |||
Grade 0 | 24 (50%) | 15 (52%) | 9 (47%) | |
Grade 1 | 11 (23%) | 5 (17%) | 6 (32%) | |
Grade 2 | 9 (19%) | 8 (28%) | 1 (5%) | |
Grade 3 | 4 (8%) | 1 (3%) | 3 (16%) | |
Skin rash and/or acneiform eruption | 0.1354 | |||
Grade 0 | 7 (15%) | 4 (14%) | 3 (16%) | |
Grade 1 | 33 (69%) | 21 (72%) | 12 (63%) | |
Grade 2 | 5 (10%) | 4 (14%) | 1 (5%) | |
Grade 3 | 3 (6%) | 0 (0%) | 3 (16%) | |
Dry skin | 0.4461 | |||
Grade 0 | 14 (29%) | 9 (31%) | 5 (26%) | |
Grade 1 | 33 (69%) | 20 (69%) | 13 (68%) | |
Grade 2 | 1 (2%) | 0 (0%) | 1 (5%) | |
Pruritus | 0.3942 | |||
Grade 0 | 36 (75%) | 23 (79%) | 13 (68%) | |
Grade 1 | 12 (25%) | 6 (21%) | 6 (32%) | |