Table 2.

Adverse events of any grade reported in ≥10% of patients during study treatment regardless of causality

Adverse eventJS1/34.5-/47-/GM-CSF dose groupAll patients (n = 17)
Cohort 1 (n = 4)Cohort 2 (n = 4)Cohort 3 (n = 4)Cohort 4 (n = 5)
No. (%)No. (%)No. (%)No. (%)No. (%)
Any event4 (100)4 (100)4 (100)5 (100)17 (100)
Weight decreased3 (75)4 (100)4 (100)5 (100)16 (94)
Constipation4 (100)3 (75)3 (75)5 (100)15 (88)
Mucosal inflammation3 (75)4 (100)3 (75)4 (80)14 (82)
Radiation skin injury1 (25)4 (100)4 (100)5 (100)14 (82)
Anemia2 (50)4 (100)4 (100)3 (60)13 (76)
Nausea4 (100)4 (100)2 (50)3 (60)13 (76)
Dysphagia4 (100)3 (75)1 (25)4 (80)12 (71)
Pyrexia3 (75)2 (50)1 (25)4 (80)10 (59)
Dehydration1 (25)1 (25)4 (100)3 (60)9 (53)
Dry mouth0 (0)3 (75)2 (50)4 (80)9 (53)
Neutropenia2 (50)3 (75)2 (50)1 (20)8 (47)
Pharyngolaryngeal pain2 (50)2 (50)1 (25)3 (60)8 (47)
Leukopenia1 (25)4 (100)1 (25)1 (20)7 (41)
Fatigue1 (25)0 (0)2 (50)3 (60)6 (35)
Odynophagia1 (25)2 (50)2 (50)1 (20)6 (35)
Oral candidiasis0 (0)0 (0)3 (75)3 (60)6 (35)
Vomiting2 (50)1 (25)1 (25)2 (40)6 (35)
Anorexia1 (25)0 (0)2 (50)2 (40)5 (29)
Diarrhea3 (75)1 (25)0 (0)1 (20)5 (29)
Tinnitus1 (25)0 (0)2 (50)2 (40)5 (29)
Dysgeusia0 (0)0 (0)2 (50)2 (40)4 (24)
Insomnia2 (50)0 (0)1 (25)1 (20)4 (24)
Mouth ulceration0 (0)1 (25)1 (25)2 (40)4 (24)
Renal failure1 (25)2 (50)1 (25)0 (0)4 (24)
Anxiety2 (50)0 (0)0 (0)1 (20)3 (18)
Confusional state0 (0)2 (50)1 (25)0 (0)3 (18)
Cough1 (25)0 (0)1 (25)1 (20)3 (18)
Depressed mood1 (25)0 (0)1 (25)1 (20)3 (18)
Dyspepsia2 (50)0 (0)0 (0)1 (20)3 (18)
Febrile neutropenia2 (50)0 (0)1 (25)0 (0)3 (18)
Hypokalemia0 (0)1 (25)1 (25)1 (20)3 (18)
Hyponatremia1 (25)1 (25)1 (25)0 (0)3 (18)
Lymphopenia1 (25)1 (25)0 (0)1 (20)3 (18)
Rash0 (0)0 (0)3 (75)0 (0)3 (18)
Stomatitis1 (25)0 (0)1 (25)1 (20)3 (18)
Thrombocytopenia0 (0)1 (25)2 (50)0 (0)3 (18)
Abdominal discomfort0 (0)0 (0)1 (25)1 (20)2 (12)
Azotemia1 (25)1 (25)0 (0)0 (0)2 (12)
Depression0 (0)2 (50)0 (0)0 (0)2 (12)
Dizziness0 (0)0 (0)2 (50)0 (0)2 (12)
Dysphonia0 (0)2 (50)0 (0)0 (0)2 (12)
Erythema1 (25)0 (0)1 (25)0 (0)2 (12)
Headache0 (0)1 (25)0 (0)1 (20)2 (12)
Hypogeusia0 (0)0 (0)1 (25)1 (20)2 (12)
Hypotension0 (0)1 (25)1 (25)0 (0)2 (12)
Injection site hemorrhage0 (0)0 (0)1 (25)1 (20)2 (12)
Injection site reaction0 (0)0 (0)1 (25)1 (20)2 (12)
Lower respiratory tract infection1 (25)1 (25)0 (0)0 (0)2 (12)
Malaise2 (50)0 (0)0 (0)0 (0)2 (12)
Pharyngitis1 (25)1 (25)0 (0)0 (0)2 (12)
Stomach discomfort0 (0)0 (0)1 (25)1 (20)2 (12)
Syncope1 (25)0 (0)1 (25)0 (0)2 (12)

NOTE: Cohort 1, 106 pfu/mL on four occasions, maximum of 4 mL per dose. Cohort 2, 106 pfu/mL once followed by 107 on three occasions, maximum of 4 mL per dose. Cohort 3, 106 pfu/mL once followed by 108 on three occasions, maximum of 4 mL per dose. Expansion cohort, 106 pfu/mL once followed by 108 on three occasions, maximum of 8 mL per dose.