Table 3.

Adverse Events Attributable to PVSRIPO, According to Grade, in the 52 Patients in the Dose-Expansion Phase.^*

Body System and Adverse Event	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
	number of patients (percent)
Eye disorder
Blurred vision	1 (2)	—	—	—	—
Diplopia	1 (2)	—	—	—	—
Focusing difficulty	1 (2)	—	—	—	—
Visual field cut or hemianopia	8 (15)	2 (4)	—	—	—
Gastrointestinal disorder
Nausea	5 (10)	—	—	—	—
Vomiting	3 (6)	—	—	—	—
General disorder or administration-site condition
Fatigue	4 (8)	2 (4)	—	—	—
Gait disturbance	4 (8)	—	1 (2)	—	—
Nervous system disorder
Cerebral edema	—	—	—	1 (2)	—
Cognitive disturbance	12 (23)	1 (2)	—	—	—
Dysphasia	7 (13)	8 (15)	—	—	—
Dystonia	—	—	1 (2)	—	—
Facial muscle weakness	1 (2)	—	—	—	—
Headache	12 (23)	14 (27)	1 (2)	—	—
Intracranial hemorrhage	1 (2)	—	—	—	—
Paresthesia	7 (13)	—	—	—	—
Pyramidal tract syndrome†	14 (27)	8 (15)	4 (8)	—	—
Seizure	19 (37)	2 (4)	1 (2)	—	1 (2)
Psychiatric disorder
Confusion	3 (6)	5 (10)	1 (2)	—	—
Delusions	—	—	1 (2)	—	—
Hallucinations	1 (2)	—	—	—	—
Renal and urinary disorder: urinary incontinence	1 (2)	—	—	—	—
Vascular disorder: hypertension	—	1 (2)	—	—	—
Total no. of patients with an event‡	14 (27)	23 (44)	9 (17)	0	1 (2)

^*In the dose-expansion phase, 6 patients received dose level 2 (3.3×10⁸ TCID₅₀), 31 received dose level −1 (5.0×107 TCID₅₀), and 15 received dose level −2 (10⁷ TCID₅₀).

^†Pyramidal tract syndrome was defined as hemiparesis.

^‡Each patient is included only once in the total row under the grade level that represents their highest-grade event.