Table 2.
Treatment‐related treatment‐emergent adverse events (occurring in ≥10% of the total study population)
| Preferred terma | 1‐30 mg (n = 12) | 60 mg (n = 3) | 100 mg (n = 3) | 140 mg (n = 3) | 180 mg (n = 3) | Total (N = 24) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | |
| Blood creatinine increased | 2 (16.7) | – | 2 (66.7) | – | 1 (33.3) | – | 3 (100.0) | – | 1 (33.3) | – | 9 (37.5) | – |
| Hyperphosphatemia | – | – | – | – | 3 (100.0) | – | 3 (100.0) | – | 3 (100.0) | – | 9 (37.5) | – |
| ALT increased | – | – | 1 (33.3) | – | – | – | 3 (100.0) | – | 2 (66.7) | 2 (66.7) | 6 (25.0) | 2 (8.3) |
| Diarrhea | – | – | 2 (66.7) | – | – | – | 1 (33.3) | – | 3 (100.0) | – | 6 (25.0) | – |
| Lipase increased | 1 (8.3) | – | 1 (33.3) | – | 1 (33.3) | – | 1 (33.3) | – | 1 (33.3) | – | 5 (20.8) | – |
| Nausea | 1 (8.3) | – | 1 (33.3) | – | 1 (33.3) | – | 1 (33.3) | – | 1 (33.3) | – | 5 (20.8) | – |
| AST increased | – | – | – | – | – | – | 2 (66.7) | – | 2 (66.7) | 1 (33.3) | 4 (16.7) | 1 (4.2) |
| PPE syndrome | – | – | 1 (33.3) | – | – | – | 1 (33.3) | – | 2 (66.7) | – | 4 (16.7) | – |
| Anemia | – | – | 1 (33.3) | – | 1 (33.3) | – | 1 (33.3) | – | – | – | 3 (12.5) | – |
| Blood ALP increased | – | – | – | – | 1 (33.3) | – | 2 (66.7) | – | – | – | 3 (12.5) | – |
| Dysgeusia | – | – | – | – | – | – | 2 (66.7) | – | 1 (33.3) | – | 3 (12.5) | – |
| Retinal detachment | – | – | – | – | 2 (66.7) | – | 1 (33.3) | – | – | – | 3 (12.5) | – |
| Vomiting | – | – | 1 (33.3) | – | – | – | 1 (33.3) | – | 1 (33.3) | 1 (33.3) | 3 (12.5) | 1 (4.2) |
Values are shown as n (%); percentages are based on the number of treated patients in the relevant treatment cohort.
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; PPE, palmar‐plantar erythrodysesthesia; –, no incidence.
a
Coded using the Medical Dictionary for Regulatory Activities, version 20.1.