Table 1.

Top twenty most frequently reported reactions in each ‘clean’ cohort (#6–#8). The table lists a total of forty reactions, most frequently reported in each cohort, after filtering for statistical significance (Fisher’s exact test p-value < 0.05), PRR signal > 1, and excluding terms either reflecting the patients’ disease or not describing physiological effects (namely, ‘transfusion’, ‘death’, ‘malignant neoplasm progression’, ‘neoplasm malignant’, ‘prescribed overdose’, ‘adverse event’, ‘inappropriate schedule of drug administration’). In total there were 1484 reaction terms reported in all three cohorts, indicating overlap between the mentioning of reactions in the sets: 1130, 675, and 591 reaction terms were reported in the 2704 AE of the ipilimumab (only), 890 AEs of nivolumab (only), and 682 AEs of the ipilimumab and nivolumab (only) cohorts, respectively.

Cohort	Ipilimumab and Nivolumab (#8)			Ipilimumab (#6)			Nivolumab (#7)
Order	Name	AEs	%	Name	AEs	%	Name	AEs	%
1	Diarrhoea	67	9.9	Diarrhoea	388	14.3	Hypothyroidism	42	4.7
2	Colitis	65	9.5	Colitis	299	11.1	Diarrhoea	38	4.3
3	Pyrexia	48	7.0	Rash	176	6.5	Pruritus	29	3.3
4	Rash	38	5.6	Fatigue	139	5.1	Alanine aminotransferase increased	21	2.4
5	Hypophysitis	24	3.5	Hypophysitis	125	4.6	Decreased appetite	21	2.4
6	Pneumonitis	21	3.1	Pyrexia	107	3.9	Aspartate aminotransferase increased	20	2.2
7	Hyperthyroidism	20	2.9	Vomiting	99	3.7	Colitis	18	2.0
8	Hypothyroidism	20	2.9	Pruritus	79	2.9	Gamma-glutamyltransferase increased	17	1.9
9	Pruritus	19	2.8	Dehydration	78	2.9	Pneumonitis	16	1.8
10	Hepatitis	18	2.6	Decreased appetite	74	2.7	Hepatic function abnormal	15	1.7
11	Pneumonia	18	2.6	Abdominal pain	67	2.5	Interstitial lung disease	15	1.7
12	General physical health deterioration	17	2.5	Enterocolitis	56	2.1	Leukoderma	15	1.7
13	Abdominal pain	16	2.3	Weight decreased	53	2.0	Blood alkaline phosphatase increased	14	1.6
14	Alanine aminotransferase increased	14	2.1	Anaemia	46	1.7	Acute kidney injury	11	1.2
15	Dehydration	14	2.1	Adrenal insufficiency	42	1.6	Lung disorder	11	1.2
16	Aspartate aminotransferase increased	11	1.6	Sepsis	38	1.4	Sepsis	11	1.2
17	Liver disorder (not further clarified)	11	1.6	Hepatitis	36	1.3	Infusion related reaction	10	1.1
18	Myocarditis	11	1.6	Hyponatraemia	35	1.3	Renal impairment	10	1.1
19	Sepsis	11	1.6	Intestinal perforation	35	1.3	Uveitis	10	1.1
20	Type 1 diabetes mellitus	11	1.6	Hypothyroidism	34	1.3	Adrenal insufficiency|liver disorder|diabetic ketoacidosis	9	1.0
Total	591 reactions	682	-	1130 reactions	2704	-	675 reactions	890	-