Table 3.
Adverse Event, n (%) | Linsitinib + Erlotinib (N = 43) | Placebo + Erlotinib (N = 44) | ||||
---|---|---|---|---|---|---|
Grade 1/2 | Grade 3 | Grade 4 | Grade 1/2 | Grade 3 | Grade 4 | |
Overall | 21 (48.8) | 20 (46.5) | 2 (4.7) | 34 (79.1) | 10 (22.7) | 0 |
Skin rash | 33 (76.7) | 3(7.0) | 0 | 40 (90.9) | 3 (6.8) | 0 |
Diarrhea | 28 (65.1) | 1 (2.3) | 0 | 29 (65.9) | 4 (9.1) | 0 |
Dry skin | 20 (46.5) | 0(0) | 0 | 18 (40.9) | 0 | 0 |
Fatigue | 12 (27.9) | 4 (9.3) | 0 | 15 (34.1) | 1 (2.3) | 0 |
Nausea | 15 (34.9) | 4 (9.3) | 0 | 12 (27.3) | 0 | 0 |
Decreased appetite | 16 (37.2) | 2 (4.7) | 0 | 8 (18.2) | 1 (2.3) | 0 |
Paronychia | 8 (18.6) | 0 | 0 | 14 (31.8) | 0 | 0 |
Alopecia | 5 (11.6) | 0 | 0 | 14 (31.8) | 0 | 0 |
Stomatitis | 11 (25.6) | 0 | 0 | 7 (15.9) | 0 | 0 |
Vomiting | 11 (25.6) | 2 (4.7) | 0 | 4 (9.1) | 0 | 0 |
Pruritus | 4 (9.3) | 0 | 0 | 12 (27.3) | 0 | 0 |
Increased ALT | 3(7.0) | 9 (20.9) | 2 (4.7) | 0 | 1 (2.3) | 0 |
Increased AST | 7 (16.3) | 5 (11.6) | 0 | 1 (2.3) | 0 | 0 |
Dysgeusia | 7 (16.3) | 0 | 0 | 6 (13.6) | 0 | 0 |
Dry eye | 7 (16.3) | 0 | 0 | 5 (11.4) | 0 | 0 |
Hyperglycemia | 7 (16.3) | 1 (2.3) | 0 | 1 (2.3) | 0 | 0 |
Dry mouth | 5 (11.6) | 0 | 0 | 3 (6.8) | 0 | 0 |
Increased blood bilirubin | 6 (14.0) | 1 (2.3) | 0 | 0 | 0 | 0 |
Decreased weight | 4 (9.3) | 1 (2.3) | 0 | 2 (4.5) | 0 | 0 |
Increased blood creatinine | 5 (11.6) | 0 | 0 | 0 | 0 | 0 |
Skin fissures | 0 | 0 | 0 | 5 (11.4) | 0 | 0 |
Abbreviations: ALT = Alanine aminotransferase; AST = aspartate aminotransferase.