Table 3 Most common treatment-related adverse events occurring in >5% of patients overall (any Common Terminology Criteria for Adverse Events grade; safety analysis set).
Preferred term, %a | E7449 dose cohort, mg | ||||||
|---|---|---|---|---|---|---|---|
50 (n = 3) | 100 (n = 3) | 200 (n = 4) | 400 (n = 4) | 600b (n = 21) | 800 (n = 6) | Total (N = 41) | |
Fatigue | 33.3 | 66.7 | 0 | 75.0 | 66.7 | 100.0 | 63.4 |
Chromaturia | 0 | 0 | 0 | 50.0 | 66.7 | 66.7 | 48.8 |
Nausea | 33.3 | 33.3 | 50.0 | 25.0 | 33.3 | 33.3 | 34.1 |
Diarrhoea | 33.3 | 33.3 | 0 | 50.0 | 23.8 | 50.0 | 29.3 |
Maculopapular rash | 0 | 33.3 | 25.0 | 25.0 | 33.3 | 16.7 | 26.8 |
Decreased appetite | 33.3 | 0 | 0 | 25.0 | 23.8 | 50.0 | 24.4 |
Photosensitivity reaction | 33.3 | 33.3 | 0 | 25.0 | 23.8 | 33.3 | 24.4 |
Vomiting | 33.3 | 0 | 25.0 | 0 | 14.3 | 33.3 | 17.1 |
Depression | 0 | 33.3 | 25.0 | 50.0 | 4.8 | 16.7 | 14.6 |
Periorbital oedema | 0 | 0 | 0 | 25.0 | 19.0 | 0 | 12.2 |
Pruritus | 0 | 33.3 | 0 | 0 | 19.0 | 0 | 12.2 |
Skin hyperpigmentation | 0 | 33.3 | 0 | 0 | 9.5 | 33.3 | 12.2 |
Increased blood alkaline phosphatase | 0 | 0 | 0 | 25.0 | 14.3 | 0 | 9.8 |
Constipation | 33.3 | 33.3 | 0 | 0 | 9.5 | 0 | 9.8 |
Dry skin | 0 | 33.3 | 0 | 0 | 4.8 | 33.3 | 9.8 |
Abdominal pain | 0 | 33.3 | 0 | 25.0 | 0 | 16.7 | 7.3 |
Anaemia | 33.3 | 0 | 0 | 0 | 9.5 | 0 | 7.3 |
Dizziness | 0 | 0 | 0 | 0 | 4.8 | 33.3 | 7.3 |
Dysgeusia | 0 | 0 | 0 | 0 | 14.3 | 0 | 7.3 |
Onycholysis | 0 | 0 | 0 | 25.0 | 9.5 | 0 | 7.3 |
Erythematous rash | 0 | 0 | 0 | 0 | 9.5 | 16.7 | 7.3 |
