Table 1.

Number of treatment-related adverse events per patient

NMeanSDMinMedianMax
Overall131.40.71.01.03.0
Cohort
 112.02.02.02.0
 2 (MTD)61.20.41.01.02.0
 331.71.21.01.03.0
 431.30.61.01.02.0

NOTE: Worst grade of reported adverse event/toxicity per patient. Thirteen patients had treatment-related, grade 3 or 4 events [28.3%, (95% exact CI: 16%–43%)]. For patients with treatment-related, grade 3 or 4 events, the table summarizes the number per patient. Adverse events classified as “not related” are included. Grades: 1, mild; 2, moderate; 3, severe; 4, life-threatening; 5, death.