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Table 1 Baseline characteristics - randomized patients.

From: A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

Characteristic Ipilimumab 3 mg/kg (n = 40) Ipilimumab 10 mg/kg (n = 42) Total (N = 82)
Male gender, % 70.0 57.1 63.4
Race, n (%)    
   Asian 1 (2.5) 0 1 (1.2)
   Black 0 1 (2.4) 1 (1.2)
   White 39 (97.5) 41 (97.6) 80 (97.6)
Age in yrs, mean (range) 53.9 (23.0-78.0) 56.2 (26.0-87.0) 55.0 (23.0-87.0)
   < 65, n (%) 31 (77.5) 29 (69.0) 60 (73.2)
   ≥ 65, n (%) 9 (22.5) 13 (31.0) 22 (26.8)
Disease stage, n (%)    
   III 1 (2.5) 2 (4.8) 3 (3.7)
   IV 39 (97.5) 40 (95.2) 79 (96.3)
M-stage, n (%)    
   M0 0 2 (4.8) 2 (2.4)
   M1A 12 (30.0) 9 (21.4) 21 (25.6)
   M1B 6 (15.0) 3 (7.1) 9 (11.0)
   M1C 22 (55.0) 28 (66.7) 50 (61.0)
ECOG-PS, n (%)    
   0 25 (62.5) 27 (64.3) 52 (63.4)
   1 15 (37.5) 15 (35.7) 30 (36.6)
Time since initial diagnosis in months, mean (range) 69.0 (1.1-384.0) 55.8 (3.8-237.9) 62.2 (1.1-384.0)
Any prior systemic therapy received, n (%) 29 (72.5) 33 (78.6) 62 (75.6)
   Number received    
   1, n (%) 15 (37.5) 19 (45.2) 34 (41.5)
   2, n (%) 7 (17.5) 8 (19.0) 15 (18.3)
   3, n (%) 6 (15.0) 5 (11.9) 11 (13.4)
   ≥ 5, n (%) 1 (2.5) 1 (2.4) 2 (2.4)
Any prior immunotherapy received, n (%) (57.5) (61.9)  
   interleukin-2, n (%) (45.0) (38.1)  
   interferon-α, n (%) (22.5) (19.0)  
Setting of prior therapy*    
   Adjuvant therapy, n (%) 10 (25.0) 10 (23.8) 20 (24.4)
   Metastatic disease, n (%) 26 (65.0) 28 (66.7) 54 (65.9)
   Neoadjuvant therapy, n (%) 0 1 (2.4) 1 (1.2)
  1. *Systemic therapy may have been received in > 1 setting.
  2. ECOG-PS: Eastern Cooperative Oncology Group performance status.