Table 5. All-grade treatment-related AEs ⩾10% patients in either treatment and grade 3/4 treatment-related AEs.
|
Linsitinib/erlotinib (n=100) |
Placebo/erlotinib (n=101) |
Total (N=201) |
||||
|---|---|---|---|---|---|---|
| Adverse event, n (%) | All grade | Grade 3/4 | All grade | Grade 3/4 | All grade | Grade 3/4 |
| Drug eruption | 67 (67.0) | 8 (8.0) | 59 (58.4) | 4 (4.0) | 126 (62.7) | 12 (6.0) |
| Diarrhoea | 38 (38.0) | 4 (4.0) | 29 (28.7) | 2 (2.0) | 67 (33.3) | 6 (3.0) |
| Decreased appetite | 20 (20.0) | 0 (0) | 15 (14.9) | 0 (0) | 35 (17.4) | 0 (0) |
| Pruritus | 14 (14.0) | 0 (0) | 19 (18.8) | 0 (0) | 33 (16.4) | 0 (0) |
| Nausea | 18 (18.0) | 2 (2.0) | 11 (10.9) | 0 (0) | 29 (14.4) | 2 (1.0) |
| Dry skin | 12 (12.0) | 2 (2.0) | 10 (9.9) | 0 (0) | 22 (10.9) | 2 (1.0) |
| Fatigue | 11 (11.0) | 2 (2.0) | 10 (9.9) | 2 (2.0) | 21 (10.4) | 4 (2.0) |
| Paronychia | 9 (9.0) | 0 (0) | 11 (10.9) | 2 (2.0) | 20 (10.0) | 2 (1.0) |
| Vomiting | 13 (13.0) | 1 (1.0) | 7 (6.9) | 1 (1.0) | 20 (10.0) | 2 (1.0) |
| Hyperglycaemia | 15 (15.0) | 4 (4.0) | 4 (4.0) | 0 (0) | 19 (9.5) | 4 (2.0) |
| Increased ALT | 12 (12.0) | 4 (4.0) | 5 (5.0) | 2 (2.0) | 17 (8.5) | 6 (3.0) |
| Stomatitis | 11 (11.0) | 1 (1.0) | 6 (5.9) | 1 (1.0) | 17 (8.5) | 2 (1.0) |
| Increased AST | 7 (7.0) | 0 (0) | 6 (5.9) | 2 (2.0) | 13 (6.5) | 2 (1.0) |
Abbreviations: AE=adverse event; ALT=alanine transferase; AST=aspartate transferase.