Table 1.

Incidence of the most common any grade irAEs in pivotal first-line metastatic studies

Study name	Immunotherapy and dose	Additional agents	Tumour	irAEs	Incidence (%)
Checkmate 067 [10]	Ipilimumab 3 mg/kg Nivolumab 1 mg/kg	Nil	Melanoma	Skin Diarrhoea/colitis Hepatic	62 48 33
KEYNOTE 024 [11]	Pembrolizumab 200 mg	Nil	NSCLC	Hypothyroidism Hyperthyroidism Pneumonitis	9.1 7.8 5.8
Checkmate 214 [12]	Ipilimumab 1 mg/kg Nivolumab 3 mg/kg	Nil	RCC	Fatigue Pruritus Diarrhoea	37 28 27
KEYNOTE 048 [13]	Pembrolizumab 200 mg	Monotherapy, platinum and 5-FU based chemotherapy arms	Head and neck SqCC	Hypothyroidism Pneumonitis Hyperthyroidism	18 6 3
IMbrave150 [14]	Atezolizumab 1200 mg	Bevacizumab 15 mg/kg	HCC	Fatigue AST increase Pruritus	20.4 19.5 19.5
TOPAZ-1 [15]	Durvalumab 1500 mg	Cisplatin Gemcitabine	Cholangiocarcinoma	Hypothyroidism Rash/dermatitis Hepatitis	5.9 3.6 1.2
Checkmate 649 [16]	Nivolumab 240 mg or 360 mg	FOLFOX	Gastric adenocarcinoma	Gastrointestinal Skin Hepatic	34 27 26
JAVELIN Bladder 100 [17]	Avelumab 10 mg/kg	Cisplatin/carboplatin-gemcitabine	Urothelial carcinoma	Fatigue Pruritus Diarrhoea	17.7 17.2 16.6
Checkmate 743 [18]	Ipilimumab 1 mg/kg Nivolumab 3 mg/kg	Nil	Mesothelioma	Colitis Infusion reaction Hepatitis	3.0 2.0 1.7

AST aspartate aminotransferase, HCC hepatocellular carcinoma, irAE immune-related adverse event, NSCLC non-small cell lung cancer, RCC renal cell carcinoma, SqCC squamous cell carcinoma