Table 2.

Adverse events in the vaccine arm

Adverse events, GI‐6301, all cycles	NC/NA, %	Grade 1, %	Grade 2, %	Grade 3, %	Grade 4, %	Grade 5, %	All grades, %
Injection‐site reaction	9	64	18	9	0	0	91
Lymphocyte count decreased	18	18	27	36	0	0	82
Fatigue	45	27	9	18	0	0	55
Mucositis oral	64	0	36	0	0	0	36
Anemia	73	27	0	0	0	0	27
Dermatitis radiation	73	18	9	0	0	0	27
Diarrhea	73	9	0	18	0	0	27
Dry mouth	73	9	18	0	0	0	27
Nausea	73	9	9	9	0	0	27
White blood cells decreased	73	27	0	0	0	0	27
Anorexia	82	9	0	9	0	0	18
Dysgeusia	82	0	18	0	0	0	18
Headache	82	18	0	0	0	0	18
Oral pain	82	18	0	0	0	0	18
Paresthesia	82	18	0	0	0	0	18
Sore throat	82	18	0	0	0	0	18
Vomiting	82	9	0	9	0	0	18
Weight loss	82	9	0	9	0	0	18
Anal hemorrhage	91	9	0	0	0	0	9
Chills	91	9	0	0	0	0	9
Cough	91	9	0	0	0	0	9
Dehydration	91	0	0	9	0	0	9
Dysphagia	91	0	0	9	0	0	9
Erythema multiforme	91	9	0	0	0	0	9
Fall	91	9	0	0	0	0	9
Fever	91	9	0	0	0	0	9
Flatulence	91	9	0	0	0	0	9
Flu‐like symptoms	91	9	0	0	0	0	9
Hiccups	91	9	0	0	0	0	9
Hypothyroidism	91	9	0	0	0	0	9
Infections and infestations, other	91	9	0	0	0	0	9
Malaise	91	9	0	0	0	0	9
Mucosal infection	91	0	9	0	0	0	9
Myalgia	91	9	0	0	0	0	9
Nasal congestion	91	0	9	0	0	0	9
Neck edema	91	0	9	0	0	0	9
Neck pain	91	9	0	0	0	0	9
Platelet count decreased	91	9	0	0	0	0	9
Postnasal drip	91	9	0	0	0	0	9
Presyncope	91	0	9	0	0	0	9
Rash acneiform	91	9	0	0	0	0	9
Salivary duct inflammation	91	0	9	0	0	0	9
Sepsis	91	0	0	0	9	0	9
Sinusitis	91	0	9	0	0	0	9
Stroke	91	0	0	9	0	0	9
Voice alteration	91	9	0	0	0	0	9

Highest adverse event grade is noted for each patient. Adverse events at least possibly related to research (vaccine and/or radiation therapy).

Abbreviation: NC/NA, no change from baseline/no adverse event.