Patient characteristics

No. (%)
CharacteristicDiarrhea treated with immunosuppressants, n = 79Diarrhea without treatment, n = 38No diarrhea, n = 210P
Mean age (years, SD)59.8 (15)62.2 (12)59.2 (14)0.480
Male sex53 (67)25 (66)133 (63)0.825
Race< 0.001
 White75 (95)32 (84)154 (73)
 Other4 (5)6 (16)56 (27)
Comorbidities present24 (30)9 (24)62 (30)0.733
Underlying autoimmune disorder4 (5)1 (3)13 (6)0.663
History of smoking36 (46)20 (53)107 (51)0.671
History of use of nonsteroidal anti-inflammatory agents38 (48)15 (39)80 (38)0.300
ECOG performance status0.070
 0–278 (99)38 (100)197 (94)
 3–41 (1)0 (0)13 (6)
Malignancy type< 0.001
 Melanoma55 (70)9 (24)56 (27)
 Solid tumor23 (29)14 (37)111 (53)
 Hematologic1 (1)15 (39)43 (20)
Cancer Stagea< 0.001
 Stage III16 (21)2 (9)7 (4)
 Stage IV61 (79)21 (91)149 (96)
Colitis grade 2–349 (62)
Checkpoint inhibitor type< 0.001
 Ipilimumab48 (61)23 (61)67 (32)
 Nivolumab5 (6)8 (21)87 (41)
 Pembrolizumab13 (16)6 (16)50 (24)
 Combinationb12 (15)1 (3)6 (3)
 Atezolizumab1 (1)0 (0)0 (0)

Abbreviations: ECOG, Eastern Cooperative Oncology Group; SD, standard deviation

aThe American Joint Committee on Cancer staging system was used. Stage was known in 77 patients in the immunosuppressant group, 23 in the untreated diarrhea group, and 156 in the no diarrhea group

bCombination therapy consisted of ipilimumab + nivolumab