Table 3.
Treatment-related adverse events in >10% of 255 patients with ALK rearranged non-small cell lung cancer treated on trials A8081001 and PROFILE 100527,29
| Adverse event | Treatment-related | |
|---|---|---|
| All grades n (%) | Grade 3–4 n (%) | |
| Eye disorders* | 159 (62%) | 0 |
| Gastrointestinal disorders | ||
| Nausea | 136 (53%) | 0 |
| Diarrhea | 109 (43%) | 0 |
| Vomiting | 101 (40%) | 0 |
| Constipation | 69 (27%) | 1 (<1%) |
| Esophageal disorder** | 29 (11%) | 0 |
| General | ||
| Edema | 72 (28%) | 0 |
| Fatigue | 51 (20%) | 4 (2%) |
| Decreased appetite | 49 (19%) | 0 |
| Nervous system disorder | ||
| Dizziness | 42 (16%) | 0 |
| Neuropathy | 34 (13%) | 1 (<1%) |
| Dysgeusia | 30 (12%) | 0 |
| Liver disorders | ||
| Alanine transaminase increase | 34 (13%) | 14 (5%) |
| Skin disorders | ||
| Rash | 25 (10%) | 0 |
*
Notes: Includes photopsia, diplopia, photophobia, blurred vision, visual field defect, visual impairment, vitreous floaters, visual brightness, and reduced visual acuity;
**
includes dyspepsia, dysphagia, epigastric discomfort/pain/burning, esophagitis, esophageal obstruction/pain/spasm/ulcer, gastroesophageal reflux, odynophagia, and reflux esophagitis.