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. Author manuscript; available in PMC: 2017 Jan 14.
Published in final edited form as: N Engl J Med. 2016 Jul 14;375(2):143–153. doi: 10.1056/NEJMoa1601202

Table 2.

Adverse Events and Outcomes of Treatment.*

Variable No. of Patients
Adverse event
Patients who could be evaluated for adverse events 28
GVHD — dose-limiting toxicity
  Chronic GVHD of liver 3
  Acute GVHD of gut 1
Immune-related adverse events
  Death 1
  Pneumonitis
    Grade 4 1
    Grade 2 2
  Colitis, grade 3 1
  Immune thrombocytopenic purpura, grade 2 1
  Diarrhea, grade 2 1
Other adverse events of grade 3 or higher regardless of attribution, or grade 1 or 2 events
      at least possibly related to ipilimumab
  Acute kidney injury, grade 3 1
  Corneal ulcer, grade 3 1
  Thrombocytopenia, grade 3 or 4 9
  Neutropenia, grade 3 or 4 3
  Anemia, grade 3 or 4 2
  Pleural effusion, grade 3 1
  Limb edema, grade 1 or 2 6
Outcome of treatment
Patients who received maximum administered dose (10 mg/kg) 22
Complete response 5
Partial response 2
Stable disease 6
Progression of disease 9
*

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.