Table 2.
Adverse events that were considered possibly/probably related to the NK cell infusion
| Clinical Events | # of Patients | Specific A/E | Dose Level 1 Grade (CTC) | Dose Level 2 Grade (CTC) | Dose Level 3 Grade (CTC) | Comment |
|---|---|---|---|---|---|---|
| Cardiac | 1 | Sinus tachycardia | 1 | Resolved spontaneously in 2 days | ||
| Nervous system | 2 | Dysmetria, dysarthria | 2 | 2 | 2 patient received steroids (one of them also had dysphagia), hospitalization, decreased symptoms within 2 days, then continued NK cell infusion | |
| 4 | Headache | 1 | 1 | 2 | ||
| 1 | Dysphagia | 2 | ||||
| 1 | Facial droop | 1 | ||||
| 1 | Seizure | 3 | (Patient 8) One episode of seizure, however MRI showed decrease in size of lesion, admitted for observation, received steroids for 2 days, given empirically for inflammation, no seizure recurrence during hospitalization (grade 3 AE for hospitalization). However seizure recurrence later with PD | |||
| 1 | Slurred speech | 3 | Intermittent, resolved with short course of steroids in 3 days (grade 3 for hospitalization) | |||
| General disorders | 2 | Fatigue | 1 | 1 | ||
| Nutritional disorder | 2 | Anorexia | 1 | |||
| Hematologic | 1 | Thrombocytopenia | Baseline grade 1, increased to grade 2 and resolved to grade 1 in 7 days | Bone marrow evaluation negative for infiltrative disease |