Table 2.
Adverse event | n | % |
---|---|---|
Rash* | 4 | 11 |
Pulmonary† | 2 | 6 |
Arthritis‡ | 1 | 3 |
Graft failure§ | 1 | 3 |
LFT elevation | 1 | 3 |
Hypertension | 1 | 3 |
Hypotension | 1 | 3 |
Acute kidney injury | 1 | 3 |
SAEs include any Common Terminology Criteria of Adverse Events 4.0 while being treated with pegIFNα, irrespective of attribution. Nine patients (25%) experienced a total of the 12 SAEs listed above.
LFT, liver function tests (aspartate transaminase/alanine transaminase).
Clinical features consistent with acute GVHD.
Pulmonary SAEs include pneumonitis (acute respiratory distress syndrome) related to infection (n = 1) and acute hypoxemia (n = 1).
Clinical features consistent with gouty arthritis.
Met criteria for DLT.