Table 2.
AEs
| AE | Grade 3 (severe) |
Grade 4 (life threatening) |
||
|---|---|---|---|---|
| No. | % | No. | % | |
| Maximum overall | ||||
| Lapatinib | 28 | 19 | 0 | 0 |
| Placebo | 8 | 6 | 0 | 0 |
| Dermatology/skin | ||||
| Rash: acne/acneiform | ||||
| Lapatinib | 4 | 3 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| Endocrine | ||||
| Hot flashes/flushes | ||||
| Lapatinib | 1 | 1 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| GI | ||||
| Diarrhea | ||||
| Lapatinib | 12 | 8 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| Mucositis/stomatitis | ||||
| Lapatinib | 1 | 1 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| GI disorders | ||||
| Dyspepsia | ||||
| Lapatinib | 1 | 1 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| General disorders and administration site conditions | ||||
| Fatigue | ||||
| Lapatinib | 4 | 3 | 0 | 0 |
| Placebo | 1 | 1 | 0 | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | ||||
| Lapatinib | 2 | 1 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | ||||
| Lapatinib | 4 | 3 | 0 | 0 |
| Placebo | 1 | 1 | 0 | 0 |
| Blood bilirubin increased | ||||
| Lapatinib | 1 | 1 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
| Neurology | ||||
| CNS cerebrovascular ischemia | ||||
| Lapatinib | 0 | 0 | 0 | 0 |
| Placebo | 1 | 1 | 0 | 0 |
| Pulmonary/upper respiratory | ||||
| Dyspnea (shortness of breath) | ||||
| Lapatinib | 2 | 1 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 |
Abbreviation: AE, adverse event.