Table 2.

AEs regardless of relationship to BGJ398 in patients with metastatic urothelial cancer

BGJ398 125 mg/day
3 weeks on/1 week off
N = 67
Treatment-emergent AEs reported in ≥10% of patients, n (%)aAll gradesGrade 3/4
All AEsb66 (98.5)46 (68.7)c
Hyperphosphatemia31 (46.3)1 (1.5)
Elevated creatinine28 (41.8)0
Fatigue25 (37.3)5 (7.5)
Constipation25 (37.3)0
Anemia24 (35.8)5 (7.5)
Decreased appetite22 (32.8)3 (4.5)
Dry mouth21 (31.3)1 (1.5)
Alopecia21 (31.3)0
Nausea19 (28.4)3 (4.5)
Stomatitis17 (25.4)2 (3)
Dysgeusia14 (20.9)0
Nail disorder14 (20.9)0
Vomiting13 (19.4)3 (4.5)
Diarrhea13 (19.4)2 (3)
Abdominal pain12 (17.9)1 (1.5)
Dyspnea12 (17.9)1 (1.5)
Arthralgia11 (16.4)2 (3)
Dry eye11 (16.4)0
Hyperlipasemia10 (14.9)7 (10.4)
Hematuria10 (14.9)0
Hyperkalemia9 (13.4)2 (3)
Urinary tract infection9 (13.4)2 (3)
Increased amylase9 (13.4)1 (1.5)
Hypercalcemia9 (13.4)1 (1.5)
Dizziness9 (13.4)0
Palmar–plantar erythrodysesthesia syndrome8 (11.9)5 (7.5)
Hyponatremia8 (11.9)4 (6)
Dry skin8 (11.9)0
Peripheral edema8 (11.9)0
Hypophosphatemia7 (10.4)5 (7.5)
Myalgia7 (10.4)0
Weight loss7 (10.4)0
Blurred vision7 (10.4)0
  • aAEs with a frequency ≥10% in all grades occurring during treatment or within 28 days of the last dose. Patients with multiple occurrences of an AE were counted only once in each AE category.

  • bPatients with multiple AEs were counted only once in the “all AEs” row.

  • c21 patients (31.3%) did not experience a grade 3/4 AE.