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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.