Table 3.
Grade ≥3 toxicity by dose level
| A. Patients treated at each dose level and grade 4 events observed
| ||||
|---|---|---|---|---|
| Cohort | No. patients | Reovirus dose (TCID50) | Total no. cycles (range) | Grade 4 event (n) |
| 1 | 4 | 3 × 109 | 16 (1-6) | 0 |
| 2 | 4 | 1 × 1010 | 20 (2-8) | 0 |
| 3 | 16 | 3 × 1010 | 62 (1-8) | 4* |
|
B. Grade ≥3 toxicity observed for each reovirus dose level (n = 24)
| ||||
| Toxicity |
Dose level
|
Total, n = 24 (%) | ||
| 1 | 2 | 3 | ||
|
| ||||
| Neutropenia | 1 | 2 | 3 | 6 (25) |
| Neutropenia with fever | 1 | 1 (4) | ||
| Thrombocytopenia | 1 | 1 (4) | ||
| Pancytopenia | 1 | 1 (4) | ||
| Fatigue | 1 | 1 (4) | ||
| Vomiting | 1 | 1 (4) | ||
| Diarrhea | 1 | 1 | 2 (8) | |
| Abdominal pain | 1 | 1 (4) | ||
| Bowel obstruction | 1 | 1 (4) | ||
| Nausea | 1 | 1 (4) | ||
| Dehydration | 2 | 2 (8) | ||
| Gastric bleed | 1 | 1 (4) | ||
| Tachycardia | 1 | 1 (4) | ||
| Increased alanine aminotransferase | 1 | 1 (4) | ||
| Perianal abscess | 1 | 1 (4) | ||
| Pyrexia | 1 | 1 (4) | ||
| Hypotension | 1 | 1 (4) | ||
| Hypokalemia | 1 | 1 (4) | ||
*
Grade 4 neutropenia (one of them developed grade 4 lymphopenia).