Table 2.
Adverse events summary.
| AE | All grades | Grade 1 | Grade 2 | Grade 3 |
|---|---|---|---|---|
| Chills | 11 (84.62%) | 10 (76.92%) | 1 (7.69%) | 0 (0%) |
| Fever | 10 (76.92%) | 7 (53.85%) | 2 (15.38%) | 1 (7.69%) |
| Vomiting | 9 (69.23%) | 8 (61.54%) | 0 (0%) | 1 (7.69%) |
| Nausea | 7 (53.85%) | 3 (23.08%) | 3 (23.08%) | 1 (7.69%) |
| Fatigue | 6 (46.15%) | 4 (30.77%) | 0 (0%) | 2 (15.38%) |
| Diarrhoea | 5 (38.46%) | 5 (38.46%) | 0 (0%) | 0 (0%) |
| Hyperglycaemia | 5 (38.46%) | 0 (0%) | 5 (38.46%) | 0 (0%) |
| Anaemia | 4 (30.77%) | 3 (23.08%) | 0 (0%) | 1 (7.69%) |
| Headache | 4 (30.77%) | 4 (30.77%) | 0 (0%) | 0 (0%) |
| White blood cell decreased | 4 (30.77%) | 2 (15.38%) | 1 (7.69%) | 1 (7.69%) |
| Abdominal pain | 3 (23.08%) | 2 (15.38%) | 1 (7.69%) | 0 (0%) |
| Alkaline phosphatase increased | 3 (23.08%) | 1 (7.69%) | 1 (7.69%) | 1 (7.69%) |
| Anorexia | 3 (23.08%) | 3 (23.08%) | 0 (0%) | 0 (0%) |
| Aspartate aminotransferase increased | 3 (23.08%) | 3 (23.08%) | 0 (0%) | 0 (0%) |
| Blood bilirubin increased | 3 (23.08%) | 3 (23.08%) | 0 (0%) | 0 (0%) |
| Lymphocyte count decreased | 3 (23.08%) | 0 (0%) | 1 (7.69%) | 2 (15.38%) |
| Neutrophil count decreased | 3 (23.08%) | 0 (0%) | 2 (15.38%) | 1 (7.69%) |
| Platelet count decreased | 3 (23.08%) | 2 (15.38%) | 1 (7.69%) | 0 (0%) |
| Proteinuria | 3 (23.08%) | 2 (15.38%) | 1 (7.69%) | 0 (0%) |
| Hyponatremia | 2 (15.38%) | 0 (0%) | 0 (0%) | 2 (15.38%) |
| Hypothyroidism | 2 (15.38%) | 2 (15.38%) | 0 (0%) | 0 (0%) |
| Musculoskeletal and connective tissue disorder—other, specify | 2 (15.38%) | 2 (15.38%) | 0 (0%) | 0 (0%) |
| Myalgia | 2 (15.38%) | 2 (15.38%) | 0 (0%) | 0 (0%) |
| Nasal congestion | 2 (15.38%) | 2 (15.38%) | 0 (0%) | 0 (0%) |
| Alanine aminotransferase increased | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Arthralgia | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Back pain | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Chronic kidney disease | 1 (7.69%) | 0 (0%) | 1 (7.69%) | 0 (0%) |
| Cough | 1 (7.69%) | 0 (0%) | 1 (7.69%) | 0 (0%) |
| Dry mouth | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Dyspnoea | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Generalised muscle weakness | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| GGT increased | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Hyperhidrosis | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Hypertension | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Hypoalbuminemia | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Lymphocyte count increased | 1 (7.69%) | 0 (0%) | 1 (7.69%) | 0 (0%) |
| Pleural effusion | 1 (7.69%) | 0 (0%) | 1 (7.69%) | 0 (0%) |
| Postnasal drip | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Pruritus | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Rash acneiform | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Rash maculo-papular | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Sinus tachycardia | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Urinary tract infection | 1 (7.69%) | 0 (0%) | 1 (7.69%) | 0 (0%) |
| Urine discoloration | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
| Vaginal dryness | 1 (7.69%) | 1 (7.69%) | 0 (0%) | 0 (0%) |
The safety and tolerability of pembrolizumab and pelareorep combination are evaluated by the frequencies and percentages of AEs for all grades, determined by NCI CTCAE v 4.03. The AEs are listed in a descending order of frequencies of AEs >10 percent for all grades.