Four (11%) patients had AEs that led to permanent discontinuation of study treatment, each due to thrombocytopenia, keratopathy, fatigue and cough, and increased alanine aminotransferase, aspartate aminotransferase, and blood creatine phosphokinase.
For the whole group, the median duration of hospitalization (counted from day 1 of study treatment to the day of hospital discharge) was significantly shorter after S-HAM with 37 days versus 49 days after standard DI (P < 0.001)—Fig.
Biomarkers are an appealing idea to assess biologic effects of study treatment and hopefully predict clinical outcome.
Effects of study treatment on the cytokine response were evaluated by comparing 2 groups with a 2-ways ANOVA.
Holter monitoring was done within 10 days of the first dose of study treatment and at weeks 1, 5, and 16.
All patients who received at least one dose of study treatment were included in the safety analysis.
The median time of study treatment was 13.1 months.
Four patients (18%) completed 1 year of study treatment.
Four participants completed 7 days of study treatment.
No deaths occurred within 30 days of study treatment.
A total of 398 courses of study treatment were administered to the 45 patients.
