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Table 4 Adverse events related to afatinib

From: The clinical efficacy of Afatinib 30 mg daily as starting dose may not be inferior to Afatinib 40 mg daily in patients with stage IV lung Adenocarcinoma harboring exon 19 or exon 21 mutations

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%)  
  1. * Data are presented as n(%)