Table 2

Treatment-related adverse events in ≥5% of patients (safety analysis set)

Dose verification
(n=20)
PK substudy
(n=57)
Phase 2
(n=223)
Total
(N=300)
Patients with an AE, n (%)Grade 1–2Grade ≥3Grade 1–2Grade ≥3Grade 1–2Grade ≥3Grade 1–2Grade ≥3
Anemia8 (40)011 (19)2 (4)42 (19)7 (3)61 (20)9 (3)
Aspartate aminotransferase increased6 (30)010 (18)1 (2)43 (19)7 (3)59 (20)8 (3)
Alanine aminotransferase increased8 (40)07 (12)1 (2)40 (18)3 (1)55 (18)4 (1)
Proteinuria7 (35)08 (14)027 (12)1 (<1)42 (14)1 (<1)
Blood bilirubin increased9 (45)05 (9)026 (12)040 (13)0
Hypothyroidism3 (15)011 (19)019 (9)033 (11)0
White cell count decreased5 (25)1 (5)1 (2)025 (11)1 (<1)31 (10)2 (<1)
Bilirubin conjugated increased7 (35)1 (5)5 (9)018 (8)1 (<1)30 (10)2 (<1)
Pyrexia5 (25)07 (12)019 (9)031 (10)0
Gamma-glutamyl transferase increased001 (2)1 (2)15 (7)11 (5)16 (5)12 (4)
Decreased appetite1 (5)05 (9)015 (7)2 (<1)21 (7)2 (1)
Malaise002 (4)1 (2)17 (8)1 (<1)19 (6)2 (<1)
Rash1 (5)04 (7)014 (6)1 (<1)19 (6)1 (<1)
Weight decreased1 (5)08 (14)010 (4)1 (<1)19 (6)1 (<1)
Platelet count decreased2 (10)04 (7)012 (5)2 (<1)18 (6)2 (<1)
Neutrophil count decreased2 (10)2 (10)1 (2)1 (2)12 (5)2 (<1)15 (5)5 (2)
Fatigue3 (15)02 (4)013 (6)018 (6)0
Blood alkaline phosphatase increased002 (4)014 (6)216 (5)2 (<1)
Cough2 (10)06 (11)08 (4)016 (5)0
Diarrhea3 (15)03 (5)09 (4)1 (<1)15 (5)1 (<1)
Hypoalbuminemia005 (9)010 (4)015 (5)0
Nausea2 (10)02 (4)011 (5)015 (5)0
Vomiting3 (15)02 (4)09 (4)1 (<1)14 (5)1 (<1)
Hyperuricemia004 (7)08 (4)3 (1)12 (4)3 (1)
  • AE, adverse event; PK, pharmacokinetic.