Table 2.
Treatment-Related AEs (TRAE) in patients treated with NOUS-PEV and pembrolizumab.
| Grade 1/2 | |
|---|---|
| Preferred term | n (%) |
| NOUS-PEV treatment-related AEsa | |
| Injection site reaction | 3 (50) |
| Fatigue | 1 (17) |
| Headache | 1 (17) |
| Hyperthyroidism | 1 (17) |
| Influenza-like illness | 1 (17) |
| Injection site erythema | 1 (17) |
| Injection site hypersensitivity | 1 (17) |
| Musculoskeletal stiffness | 1 (17) |
| Pruritus | 1 (17) |
| Pembrolizumab treatment-related AEsb | |
| Pruritus | 4 (67) |
| Diarrhea | 3 (50) |
| Fatigue | 3 (50) |
| Dyspnea | 2 (33) |
| Hyperthyroidism | 2 (33) |
| Hypothyroidism | 2 (33) |
| Injection site reaction | 2 (33) |
| Lipase increased | 2 (33) |
| Blood iron decreased | 1 (17) |
| Cough | 1 (17) |
| Dermatitis acneiform | 1 (17) |
| Dry mouth | 1 (17) |
| Dysgeusia | 1 (17) |
| Memory impairment | 1 (17) |
| Myalgia | 1 (17) |
| Nausea | 1 (17) |
| Papule | 1 (17) |
| Photopsia | 1 (17) |
| Rhabdomyolysis | 1 (17) |
| Vitiligo | 1 (17) |
Note: Summary of number (n) and percentage (%) of treatment-related AEs (TRAE). AEs were coded using MedDRA version 23.1. No patients had TRAE with CTCAE grade 3 or higher. Two patients had CTCAE grade 3/4 SAEs (1 patient had vertigo and 1 patient had hydronephrosis) all considered to be unrelated to the treatment.
aNOUS-PEV–related AEs include events attributed by the investigator to NOUS-PEV alone as well as events attributed to both NOUS-PEV and pembrolizumab.
bAEs related to pembrolizumab include events attributed by the investigator to pembrolizumab alone and events attributed to both NOUS-PEV and pembrolizumab.