Table 2

Incidence of TRAEs*

Event, n (%)Advanced RCC
N=49
Any gradeGrade 3–4
TRAEs48 (98.0)19 (38.8)
TRAEs with an incidence ≥20% (any grade) or more than one patient at grade 3–4
 Fatigue37 (75.5)2 (4.1)
 Pyrexia24 (49.0)1 (2.0)
 Chills24 (49.0)0
 Influenza-like illness24 (49.0)0
 Pruritus24 (49.0)0
 Nausea23 (46.9)0
 Rash19 (38.8)0
 Decreased appetite19 (38.8)1 (2.0)
 Arthralgia17 (34.7)1 (2.0)
 Edema peripheral16 (32.7)0
 Diarrhea15 (30.6)0
 Vomiting15 (30.6)0
 Myalgia14 (28.6)1 (2.0)
 Headache11 (22.4)0
 Hypothyroidism11 (22.4)0
 Rash maculopapular11 (22.4)0
 Cough10 (20.4)0
 Hypotension10 (20.4)2 (4.1)
 Syncope4 (8.2)4 (8.2)
 Increased lipase3 (6.1)3 (6.1)
 Hyponatremia2 (4.1)2 (4.1)
  • Data cut-off: January 8, 2021.

  • *The incidence of TRAEs from any component of the study treatment is shown. Patients are only counted once under each preferred term using the highest grade; some patients may have experienced more than one event.

  • RCC, renal cell carcinoma; TRAE, treatment-related adverse event.