Table 2.
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.