Table 4.

(A) Nonhematologic toxicity
No. patients experiencing toxicity during first course*
CohortDose level (TCID50)No. patientsFever
Fatigue
Headache
Flu-like symptoms
Grade 1-2Grade 3-4Grade 1-2Grade 3-4Grade 1-2Grade 3-4Grade 1-2Grade 3-4
11 × 108 (1 d)300000000
21 × 108 (3 d)300000010
31 × 108 (5 d)42 (3)04 (1)02 (1)01 (1)0
43 × 108 (5 d)3402 (2)03000
51 × 109 (5 d)320102010
63 × 109 (5 d)33 (3)01 (1)01 (1)01 (2)0
71 × 1010 (5 d)65 (3)04 (2)00 (1)011
83 × 1010 (5 d)85 (2)02 (6)07 (1)05 (2)0
No. patients experiencing toxicity during first course*
CohortDose level (TCID50)No. patientsNausea
Vomiting
Hyperhidrosis
Chills



Grade 1-2
Grade 3-4
Grade 1-2
Grade 3-4
Grade 1-2
Grade 3-4
Grade 1-2
Grade 3-4
11 × 108 (1 d)300000000
21 × 108 (3 d)300000000
31 × 108 (5 d)400000000
43 × 108 (5 d)300001020
51 × 109 (5 d)300000000
63 × 109 (5 d)300000000
71 × 1010 (5 d)60000101 (1)0
83 × 1010 (5 d)83 (3)01 (1)04000
(B) Hematologic toxicity
No. patients experiencing toxicity during first course*
CohortDose level (TCID50)No. patientsLymphopenia
Thrombocytopenia
Anemia
Neutropenia



Grade 1-2
Grade 3-4
Grade 1-2
Grade 3-4
Grade 1-2
Grade 3-4
Grade 1-2
Grade 3-4
11 × 108 (1 d)301 (1)000000
21 × 108 (3 d)300000000
31 × 108 (5 d)400000000
43 × 108 (5 d)300000010
51 × 109 (5 d)300000000
63 × 109 (5 d)300000000
71 × 1010 (5 d)61 (2)11 (3)00 (2)00 (7)1
83 × 1010 (5 d)83 (5)3 (3)00003 (3)2
  • NOTE: Figures represent the number of patients experiencing either grade 1/2 or 3/4 in each cohort. Figures in parentheses represent the toxicity rates in all subsequent treatment courses.

  • * Numbers in parentheses represent all subsequent courses.