Table 2.
Treatment-emergent adverse events related to protocol treatment.
| MedDRA System Organ Class/ High Level Term/ Preferred Term |
N = 30 | |||||
|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | |
| N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
| Any AE related to CDX-3379 | 3 (10) | 7 (23) | 16 (53) | 1 (3) | 0 | 27 (90) |
| Gastrointestinal disorders | 10 (33) | 9 (30) | 7 (23) | 0 | 0 | 26 (87) |
| Diarrhea | 12 (40) | 7 (23) | 6 (20) | 0 | 0 | 25 (83) |
| Nausea and vomiting symptoms | 5 (17) | 1 (3) | 0 | 0 | 0 | 6 (20) |
| Stomatitis | 2 (7) | 1 (3) | 1 (3) | 0 | 0 | 4 (13) |
| Oral dryness and saliva altered | 2 (7) | 0 | 0 | 0 | 0 | 2 (7) |
| Abdominal pain | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Duodenal ulcer | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Flatulence | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Gastrointestinal disorder | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Small intestinal hemorrhage | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Metabolism and nutrition disorders | 3 (10) | 4 (13) | 6 (20) | 1 (3) | 0 | 14 (47) |
| Hypomagnesemia | 2 (7) | 3 (10) | 3 (10) | 1 (3) | 0 | 9 (30) |
| Hypokalemia | 4 (13) | 0 | 3 (10) | 0 | 0 | 7 (23) |
| Decreased appetite | 0 | 1 (3) | 1 (3) | 0 | 0 | 2 (7) |
| Dehydration | 0 | 2 (7) | 0 | 0 | 0 | 2 (7) |
| Hypophosphatemia | 0 | 2 (7) | 0 | 0 | 0 | 2 (7) |
| Hypoalbuminemia | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Hypocalcemia | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Skin and subcutaneous tissue disorders | 2 (7) | 4 (13) | 7 (23) | 0 | 0 | 13 (43) |
| Dermal and epidermal conditions NEC | 4 (13) | 1 (3) | 1 (3) | 0 | 0 | 6 (20) |
| Dermatitis acneiform | 0 | 0 | 6 (20) | 0 | 0 | 6 (20) |
| Rashes, eruptions and exanthems NEC | 3 (10) | 2 (7) | 1 (3) | 0 | 0 | 6 (20) |
| Pruritus | 0 | 2 (7) | 0 | 0 | 0 | 2 (7) |
| Alopecia | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Onychoclasis | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Palmar-plantar erythrodysesthesia syndrome |
0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| General disorders and administration site conditions | 2 (7) | 6 (20) | 2 (7) | 0 | 0 | 10 (33) |
| Asthenic conditions | 2 (7) | 5 (17) | 0 | 0 | 0 | 7 (23) |
| Mucosal inflammation | 0 | 0 | 2 (7) | 0 | 0 | 2 (7) |
| Chills | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Pain | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Investigations | 3 (10) | 3 (10) | 2 (7) | 0 | 0 | 8 (27) |
| Electrocardiogram QT prolonged | 1 (3) | 1 (3) | 1 (3) | 0 | 0 | 3 (10) |
| Weight decreased | 2 (7) | 1 (3) | 0 | 0 | 0 | 3 (10) |
| Digestive enzymes | 0 | 2 (7) | 0 | 0 | 0 | 2 (7) |
| Alanine aminotransferase increased | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Blood creatinine increased | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Lymphocyte count decreased | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Eye disorders | 2 (7) | 1 (3) | 0 | 0 | 0 | 3 (10) |
| Conjunctival hyperemia | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Eye pruritus | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Ocular discomfort | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Vision blurred | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Nervous system disorders | 2 (7) | 0 | 1 (3) | 0 | 0 | 3 (10) |
| Dysgeusia | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Encephalopathy | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Headache | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Peripheral sensory neuropathy | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Injury | 1 (3) | 1 (3) | 0 | 0 | 0 | 2 (7) |
| Radiation skin injury | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Skin laceration | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Infections and infestations | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Fungal skin infection | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Renal and urinary disorders | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Proteinuria | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Reproductive system and breast disorders | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Perineal rash | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Any AE related to cetuximab | 5 (17) | 8 (27) | 13 (43) | 2 (7) | 0 | 28 (93) |
| Skin and subcutaneous tissue disorders | 7 (23) | 7 (23) | 9 (30) | 0 | 0 | 23 (77) |
| Dermatitis acneiform | 5 (17) | 3 (10) | 8 (27) | 0 | 0 | 16 (53) |
| Dermal and epidermal conditions NEC | 6 (20) | 1 (3) | 1 (3) | 0 | 0 | 8 (27) |
| Rashes, eruptions and exanthems NEC | 3 (10) | 2 (7) | 1 (3) | 0 | 0 | 6 (20) |
| Pruritus | 1 (3) | 2 (7) | 0 | 0 | 0 | 3 (10) |
| Palmar-plantar erythrodysesthesia syndrome |
2 (7) | 0 | 0 | 0 | 0 | 2 (7) |
| Urticaria | 2 (7) | 0 | 0 | 0 | 0 | 2 (7) |
| Dermal cyst | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Erythema | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Onychoclasis | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Metabolism and nutrition disorders | 3 (10) | 3 (10) | 9 (30) | 2 (7) | 0 | 17 (57) |
| Magnesium metabolism disorders | 4 (13) | 4 (13) | 5 (17) | 2 (7) | 0 | 15 (50) |
| Hypokalaemia | 5 (17) | 0 | 3 (10) | 0 | 0 | 8 (27) |
| Hypophosphatemia | 0 | 3 (10) | 0 | 0 | 0 | 3 (10) |
| Dehydration | 0 | 1 (3) | 1 (3) | 0 | 0 | 2 (7) |
| Hypocalcemia | 1 (3) | 1 (3) | 0 | 0 | 0 | 2 (7) |
| Decreased appetite | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Hypoalbuminemia | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Gastrointestinal disorders | 5 (17) | 7 (23) | 3 (10) | 0 | 0 | 15 (50) |
| Diarrhea | 5 (17) | 7 (23) | 1 (3) | 0 | 0 | 13 (43) |
| Nausea and vomiting symptoms | 4 (13) | 1 (3) | 0 | 0 | 0 | 5 (17) |
| Abdominal pain | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Dysphagia | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Lip dry | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Small intestinal hemorrhage | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Stomatitis | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| General disorders and administration site conditions |
2 (7) | 6 (20) | 2 (7) | 0 | 0 | 10 (33) |
| Asthenic conditions | 2 (7) | 5 (17) | 0 | 0 | 0 | 7 (23) |
| Chills | 1 (3) | 1 (3) | 0 | 0 | 0 | 2 (7) |
| Mucosal inflammation | 0 | 0 | 2 (7) | 0 | 0 | 2 (7) |
| Pain | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Infections and infestations | 4 (13) | 4 (13) | 0 | 0 | 0 | 8 (27) |
| Skin structures and soft tissue infections | 2 (7) | 4 (13) | 0 | 0 | 0 | 6 (20) |
| Fungal infections NEC | 3 (10) | 1 (3) | 0 | 0 | 0 | 4 (13) |
| Groin infection | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Lip infection | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Investigations | 2 (7) | 3 (10) | 1 (3) | 0 | 0 | 6 (20) |
| Digestive enzymes | 0 | 2 (7) | 0 | 0 | 0 | 2 (7) |
| Weight decreased | 1 (3) | 1 (3) | 0 | 0 | 0 | 2 (7) |
| Alanine aminotransferase increased | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Blood creatinine increased | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Electrocardiogram QT prolonged | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Lymphocyte count decreased | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Eye disorders | 1 (3) | 1 (3) | 1 (3) | 0 | 0 | 3 (10) |
| Blepharitis | 0 | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Conjunctival hyperemia | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Ocular discomfort | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Vision blurred | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Nervous system disorders | 3 (10) | 0 | 0 | 0 | 0 | 3 (10) |
| Headache | 2 (7) | 0 | 0 | 0 | 0 | 2 (7) |
| Peripheral sensory neuropathy | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Injury | 1 (3) | 1 (3) | 0 | 0 | 0 | 2 (7) |
| Radiation skin injury | 0 | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Skin laceration | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Reproductive system and breast disorders | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
| Perineal rash | 1 (3) | 0 | 0 | 0 | 0 | 1 (3) |
Column header counts and denominators are the number of treated subjects. Subjects are count-ed at most once in each row and under the highest grade reported. High Level Term is omitted when there is only one associated Preferred Term. Treatment-emergent AEs are defined as events reported between first dose and 30 days after the last dose of study treatment. AEs are categorized using MedDRA version 23.1.