Table 3.

Grade ≥3 toxicity by dose level

A. Patients treated at each dose level and grade 4 events observed
CohortNo. patientsReovirus dose (TCID50)Total no. cycles (range)Grade 4 event (n)
143 × 10916 (1-6)0
241 × 101020 (2-8)0
3163 × 101062 (1-8)4*
B. Grade ≥3 toxicity observed for each reovirus dose level (n = 24)
ToxicityDose levelTotal, n = 24 (%)
123
Neutropenia1236 (25)
Neutropenia with fever11 (4)
Thrombocytopenia11 (4)
Pancytopenia11 (4)
Fatigue11 (4)
Vomiting11 (4)
Diarrhea112 (8)
Abdominal pain11 (4)
Bowel obstruction11 (4)
Nausea11 (4)
Dehydration22 (8)
Gastric bleed11 (4)
Tachycardia11 (4)
Increased alanine aminotransferase11 (4)
Perianal abscess11 (4)
Pyrexia11 (4)
Hypotension11 (4)
Hypokalemia11 (4)
  • *Grade 4 neutropenia (one of them developed grade 4 lymphopenia).