Table 2.

Incidence of reovirus related adverse events reported in at least 10% of patients overall safety population

 Dose group (TCID50) with gemcitabine (1,000 mg/m2)
3 × 109 (days 1–5) N = 21 × 109 (day 1) N = 33 × 109 (day 1) N = 41 × 1010 (day 1) N = 43 × 1010 (day 1) N = 3
Number of patients with at least one AE*2 (100)3 (100)4 (100)4 (100)3 (100)
Pyrexia02 (66.7)4 (100)2 (50.0)3 (100)
Nausea1 (50.0)2 (66.7)1 (25.0)2 (50.0)1 (33.3)
Vomiting2 (100)1 (33.3)1 (25.0)2 (50.0)0
Diarrhoea02 (66.7)2 (50.0)2 (50.0)0
Chills01 (33.3)1 (25.0)1 (25.0)2 (66.7)
ALT increased1 (50.0)1 (33.3)1 (25.0)1 (25.0)1 (33.3)
Neutropenia02 (66.7)2 (50.0)00
AST increased1 (50.0)01 (25.0)1 (25.0)1 (33.3)
Fatigue0002 (50.0)1 (33.3)
GGT increased1 (50.0)1 (33.3)1 (25.0)00
Lethargy01 (33.3)1 (25.0)1 (25.0)0
Rash02 (66.7)1 (25.0)00
Febrile neutropenia01 (33.3)1 (25.0)00
Thrombocytopenia0001 (25.0)1 (33.3)
Dry mouth01 (33.3)01 (25.0)0
Blood alkaline phosphatase increased1 (50.0)1 (33.3)000
Troponin I increased1 (50.0)1 (33.3)000
Anorexia01 (33.3)001 (33.3)
Myalgia01 (33.3)001 (33.3)
Alopecia01 (33.3)1 (25.0)00
Pruritus01 (33.3)1 (25.0)00

Abbreviations: AEs = adverse events; ALT = alanine aminotransferase; AST = aspartate aminotransferase; GGT = gamma-glutamyl transferase; TCID50 = tissue culture infective dose50.

  • *Number of patients with an event (percentage of the total).

  • †Includes term White blood cell count decreased.