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.