Table 2 Most frequently observed treatment-emergent adverse eventsa.
Treatment-emergent adverse event (AE) | Severity | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1–2 | Grade 3 | |||||||||||
Events | Patients | Events | Patients | Events (N = 505) | Patients (N = 52) | |||||||
Hyperphosphataemia | 43 | 8.5% | 26 | 50% | 0 | 0 | 43 | 8.5% | 26 | 50% | ||
Dry mouth | 29 | 5.7% | 23 | 44% | 0 | 0 | 29 | 5.7% | 23 | 44% | ||
Alopecia | 23 | 4.6% | 20 | 38% | 0 | 0 | 23 | 4.6% | 20 | 38% | ||
Dysgeusia | 15 | 3.0% | 13 | 25% | 0 | 0 | 15 | 3.0% | 13 | 25% | ||
Constipation | 12 | 2.4% | 12 | 23% | 0 | 0 | 12 | 2.4% | 12 | 23% | ||
Nausea | 14 | 2.8% | 12 | 23% | 0 | 0 | 14 | 2.8% | 12 | 23% | ||
Retinal pigment epithelium detachment (RPED) | 16 | 3.2% | 11 | 21% | 0 | 0 | 16 | 3.2% | 11 | 21% | ||
Diarrhoea | 16 | 3.2% | 10 | 19% | 0 | 0 | 16 | 3.2% | 10 | 19% | ||
Dyspepsia | 14 | 2.8% | 10 | 19% | 0 | 0 | 14 | 2.8% | 10 | 19% | ||
Decreased appetite | 14 | 2.8% | 8 | 15% | 0 | 0 | 14 | 2.8% | 8 | 15% | ||
Dry eye | 9 | 1.8% | 8 | 15% | 0 | 0 | 9 | 1.8% | 8 | 15% | ||
Dry skin | 9 | 1.8% | 8 | 15% | 0 | 0 | 9 | 1.8% | 8 | 15% | ||
Epistaxis | 11 | 2.2% | 8 | 15% | 0 | 0 | 11 | 2.2% | 8 | 15% | ||
Stomatitis | 10 | 2.0% | 8 | 15% | 0 | 0 | 10 | 2.0% | 8 | 15% | ||
Alanine aminotransferase increased | 11 | 2.2% | 7 | 13% | 0 | 0 | 11 | 2.2% | 7 | 13% | ||
Aspartate aminotransferase increased | 9 | 1.8% | 6 | 12% | 1 | 0.2% | 1 | 2% | 10 | 2.0% | 7 | 13% |
Blood calcium increased | 9 | 1.8% | 7 | 13% | 0 | 0 | 9 | 1.8% | 7 | 13% | ||
Calcium phosphate product increased | 11 | 2.2% | 7 | 13% | 0 | 0 | 11 | 2.2% | 7 | 13% | ||
Fatigue | 12 | 2.4% | 7 | 13% | 1 | 0.2% | 1 | 2% | 13 | 2.6% | 7 | 13% |
Nail disorder | 7 | 1.4% | 7 | 13% | 0 | 0 | 7 | 1.4% | 7 | 13% | ||
Onycholysis | 6 | 1.2% | 6 | 12% | 0 | 0 | 6 | 1.2% | 6 | 12% | ||
Arthralgia | 5 | 1.0% | 5 | 10% | 0 | 0 | 5 | 1.0% | 5 | 10% | ||
Blood albumin decreased | 12 | 2.4% | 5 | 10% | 0 | 0 | 12 | 2.4% | 5 | 10% | ||
Blood alkaline phosphatase increased | 5 | 1.0% | 4 | 8% | 1 | 0.2% | 1 | 2% | 6 | 1.2% | 5 | 10% |
Glossodynia | 5 | 1.0% | 5 | 10% | 0 | 0 | 5 | 1.0% | 5 | 10% | ||
Lethargy | 5 | 1.0% | 5 | 10% | 1 | 0.2% | 1 | 2% | 6 | 1.2% | 5 | 10% |
Mouth ulceration | 13 | 2.6% | 5 | 10% | 0 | 0 | 13 | 2.6% | 5 | 10% | ||
Vomiting | 6 | 1.2% | 5 | 10% | 0 | 0 | 6 | 1.2% | 5 | 10% | ||
Any treatment-emergent AEb | 496 | 98.2% | 50 | 96% | 7 | 1.4% | 6 | 12% | 505 | 100% | 50 | 96% |