Dynamics of B-Cell Populations in CSF and Blood in Patients Treated with a Combination of Rituximab and Mitoxantrone

Table 2

Adverse events in study population according to the common toxicity criteria, version 3.0.

Events	Patients; 𝑛 (%)
Drug-related events affecting
Headache	5 (17.8%)
Nausea	3 (10.7%)
Fatigue	10 (35.7%)
Throat irritation	1 (3.5%)
Infusion-associated event—number of patients (%)***
First infusion at w 0	1 (3.5%)
Second infusion at w 2	0
Specific infection-associated event—number of patients (%)
Nasopharyngitis	11 (39.2%)
Upper respiratory tract infection	2 (15.3%)
Urinary tract infection	1 (3.5%)
Sinusitis	1 (3.5%)
Common toxicity criteria
Grade 1	28 (100%)
Grade 2	24 (86%)
Grade 3	16 (57%)
Grade 4	13 (46%*)
Grade 5	0
Serious adverse event*	0 (0%)

*All cases presented with transient neutropenia (less than 500 cell/mL) which resolved spontaneously by day 19.
**Serious adverse events were defined as life threatening, resulting in death, requiring prolonged inpatient hospitalization, resulting in a congenital anomaly or malignant condition, or requiring surgical intervention to prevent one of these outcomes.
**Infusion-associated event included any adverse event occurring during or within 24 hours after rituximab and mitoxantrone infusion in all patients.