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. Author manuscript; available in PMC: 2017 Oct 20.
Published in final edited form as: N Engl J Med. 2017 Apr 20;376(16):1540–1550. doi: 10.1056/NEJMoa1613878

Table 3. Adverse Events of Grade 3 or Higher or Serious Adverse Events Attributed to Eltrombopag*.

Event Patients (N = 92)
no. (%)
Skin

 Maculopapular rash 2 (2)

 Pruritus 1 (1)

Abdominal pain 2 (2)

Liver test abnormality 17 (18)

 Increased alanine aminotransferase level 9 (10)

 Increased aspartate aminotransferase level 3 (3)

 Blood bilirubin increased 12 (13)
*

All the adverse events of grade 3 or higher that were attributed by the investigators to eltrombopag are shown. The data-cutoff date was May 25, 2016. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4. Patient 87 required a temporary dose reduction of cyclosporine and eltrombopag owing to conjugated bilirubinemia associated with pruritus. Eltrombopag was discontinued temporarily as mandated by the protocol in seven patients owing to a transient elevation in the liver-enzyme levels during the administration of antithymocyte globulin or during serum sickness that occurred during the first 2 weeks.

Severe adverse events were observed in Patient 54 (in cohort 2) and Patient 86 (in cohort 3), who had maculopapular rashes of grade 3 and 2, respectively, that were associated with fever and oral pain and that resulted in hospitalization, discontinuation of eltrombopag, and treatment with glucocorticoids.