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Table 3 Safety summary.

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

Event Ipilimumab 3 mg/kg (n = 40) Ipilimumab 10 mg/kg (n = 42)
Death, n (%)   
   All 18 (45.0) 20 (47.6)
   Within 70 days of last dose 8 (20.0) 8 (19.0)
   Within 30 days of last dose 3 (7.5) 4 (9.5)
Serious AE, n (%)   
   All 18 (45.0) 20 (47.6)
   Drug-related 7 (17.5) 8 (19.0)
AE leading to study discontinuation, n (%) 5 (12.5) 11 (26.2)
Drug-related AE, n (%)   
   Any grade 33 (82.5) 32 (76.2)
   Grade 3-4 6 (15.0) 13 (31.0)
   Grade 5 1 (2.5) 1 (2.4)
irAE, n (%)   
   Overall   
   Any grade 22 (55.0) 28 (66.7)
   Grade 3-4 3 (7.5) 8 (19.0)
   Grade 5 1 (2.5) 1 (2.4)
   GI   
   Any grade 11 (27.5) 19 (45.2)
   Grade 3-4 3 (7.5) 3 (7.2)
   Grade 5 1 (2.5) 1 (2.4)
   Liver   
   Any grade 0 2 (4.8)
   Grade 3-4 0 2 (4.8)
   Endocrine   
   Any grade 2 (5.0) 2 (4.8)
   Grade 3-4 0 2 (4.8)
   Skin   
   Any grade 16 (40.0) 21 (50.0)
   Grade 3-4 0 1 (2.4)
   Other   
   Any grade 1 (2.5) 3 (7.1)
   Grade 3-4 0 1 (2.4)
  1. AE: adverse event; GI: gastrointestinal; irAE: immune-related adverse event.