Table 2

Durvalumab-related adverse events

Safety population, n=48
No of patients (%)
Any GradeGrade 1Grade 2Grade 3Grade 4Grade 5
Any AE16 (33.3)11 (22.9)5 (10.4)0 (0)0 (0)0 (0)
Serious AE0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
General disorders or administrative site conditions9 (18.8)7 (14.6)2 (4.2)0 (0)0 (0)0 (0)
 Asthenia9 (18.8)7 (14.6)2 (4.2)0 (0)0 (0)0 (0)
Gastrointestinal disorders7 (14.6)6 (12.5)1 (2.1)0 (0)0 (0)0 (0)
 Diarrhea3 (6.3)3 (6.3)0 (0)0 (0)0 (0)0 (0)
 Nausea3 (6.3)3 (6.3)0 (0)0 (0)0 (0)0 (0)
 Abdominal pain1 (2.1)0 (0)1 (2.1)0 (0)0 (0)0 (0)
 Constipation1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
 Vomiting1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
Skin and subcutaneous tissue disorders4 (8.3)2 (4.2)2 (4.2)0 (0)0 (0)0 (0)
 Pruritus3 (6.3)1 (2.1)2 (4.2)0 (0)0 (0)0 (0)
 Photosensitivity reaction1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
 Rash1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
Ear and labyrinth disorders2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
 Vertigo2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
Investigations2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
 Decreased serum thyroid stimulating hormone2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
Metabolism and nutrition disorders2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
 Decreased appetite2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
Musculoskeletal and connective tissue disorders2 (4.2)2 (4.2)0 (0)0 (0)0 (0)0 (0)
 Myalgia1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
 Polyarthritis1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
Infections and infestations1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)
 Oral fungal infection1 (2.1)1 (2.1)0 (0)0 (0)0 (0)0 (0)

  • AE, adverse event.