Table 3.
Summary of adverse events and maximum changes in laboratory tests
| Placebo (n = 3, pooled data) | Erlotinib 50 mg (n = 3) | Erlotinib 100 mg (n = 3) | |
| Treatment discontinuation for AEs | 1 | 0 | 0 |
| Serious AEs (grade ≥3) | 1 | 0 | 1 |
| Deaths | 0 | 0 | 0 |
| AEs | 8 | 3 | 9 |
| Patients with at least 1 AE | 3 | 2 | 3 |
| Treatment-emergent AEs (≥2 patients) | |||
| Headache | 3 | 1 | 0 |
| Skin rash | 1 | 1 | 1 |
| Diarrhea or dyspepsia | 1 | 1 | 1 |
| Fever or flu-like syndrome | 1 | 0 | 1 |
| Mean ± SD of maximum change in laboratory parameters | |||
| ALT (IU/L) | 140 ± 200 | 9 ± 2 | 11 ± 9 |
| AST (IU/L) | 73 ± 88 | 7 ± 6 | 7 ± 4 |
| γGT (lU/L) | 23 ± 10 | −10 ± 18 | 9.7 ± 8 |
| ALP (lU/L) | −10 ± 8 | −6 ± 6 | 13 ± 4 |
| Bilirubin (µmol/L) | 4 ± 2 | 5 ± 2 | 4 ± 2 |
| Creatinine (µmol/L) | 43 ± 27 | 20 ± 10 | 51 ± 20 |
| Hemoglobin (g/dL) | −1.4 ± 1.1 | 1.1 ± 0.1 | −1.4 ± 1.2 |
| Platelet (109/L) | −33 ± 18 | −23 ± 14 | 112 ± 176 |
AEs, adverse events; ALT, alanine aminotransaminase; AST, aspartate aminotransferase; γGT, gamma-glutamyl transferase.