Table 2.
Adverse Events Attributable to PVSRIPO, According to Dose Level, in the 9 Patients in the Dose-Escalation Phase.*
| Event, According to Body System and Grade | PVSRIPO Dose Level | ||||
|---|---|---|---|---|---|
| Level 1 (N = 1) | Level 2 (N = 1) | Level 3 (N = 1) | Level 4 (N = 2) | Level 5 (N = 4) | |
| number of patients | |||||
| General disorder or administration-site condition | |||||
|
| |||||
| Fatigue, grade 1 | — | — | — | 1 | 1 |
|
| |||||
| Gait disturbance, grade 1 | — | — | 1 | — | — |
|
| |||||
| Nervous system disorder | |||||
|
| |||||
| Cognitive disturbance, grade 2 | — | — | 1 | — | — |
|
| |||||
| Dysphasia | |||||
|
| |||||
| Grade 1 | — | — | — | — | 1 |
|
| |||||
| Grade 2 | — | — | 1 | — | — |
|
| |||||
| Headache, grade 1 | 1 | — | — | 1 | — |
|
| |||||
| Paresthesia | |||||
|
| |||||
| Grade 1 | — | 1 | — | — | — |
|
| |||||
| Grade 2 | — | — | — | 1 | 1 |
|
| |||||
| Pyramidal tract syndrome† | |||||
|
| |||||
| Grade 2 | — | — | — | — | 1 |
|
| |||||
| Grade 3 | — | — | — | 1 | 1 |
|
| |||||
| Seizure | |||||
|
| |||||
| Grade 1 | — | — | — | — | 3 |
|
| |||||
| Grade 2 | — | — | 1 | — | — |
|
| |||||
| Psychiatric disorder: confusion, grade 1 | — | — | — | — | 1 |
|
| |||||
| Total no. of patients with an event | 1 | 1 | 1 | 1 | 3 |
*
In the dose-escalation phase, dose level 1 was 108 50% tissue-culture infectious doses (TCID50), dose level 2 was 3.3×108 TCID50, dose level 3 was 109 TCID50, dose level 4 was 3.3×109 TCID50, and dose level 5 was 1010 TCID50.
†
Pyramidal tract syndrome was defined as hemiparesis.