Table 3

Immune-related adverse events in ≥2% of patients (safety analysis set)

Dose verification
(n=20)
PK substudy
(n=57)
Phase 2
(n=223)
Total
(N=300)
Patients with an irAE, n (%)Grade 1–2Grade ≥3Grade 1–2Grade ≥3Grade 1–2Grade ≥3Grade 1–2Grade ≥3
Aspartate aminotransferase increased6 (30)010 (18)1 (2)35 (16)7 (3)51 (17)8 (3)
Alanine aminotransferase increased8 (40)07 (12)1 (2)35 (16)3 (1)50 (17)4 (1)
Blood bilirubin increased9 (45)04 (7)021 (9)034 (11)0
Hypothyroidism3 (15)010 (18)018 (8)031 (10)0
Bilirubin conjugated increased7 (35)1 (5)5 (9)016 (7)1 (<1)28 (9)2 (<1)
Gamma-glutamyl transferase increased001 (2)1 (2)12 (3)11 (5)13 (4)12 (4)
Rash1 (5)04 (7)011 (5)1 (<1)16 (5)1 (<1)
Blood creatine phosphokinase increased2 (10)02 (4)08 (4)1 (<1)12 (4)1 (<1)
Diarrhea3 (15)03 (5)06 (3)1 (<1)12 (4)1 (<1)
Hyperthyroidism2 (10)01 (2)08 (4)011 (4)0
Pruritus1 (5)02 (4)06 (3)09 (3)0
Blood creatine increased1 (5)0006 (3)07 (2)0
Hyperglycemia001 (2)04 (2)1 (<1)5 (2)1 (<1)
Pneumonia0002 (4)2 (1)2 (<1)2 (<1)4 (1)
Pruritus generalized1 (5)03 (5)02 (1)06 (2)0
  • irAE, immune-related adverse event; PK, pharmacokinetic.