Table 2.
Adverse Events (AEs)
| All AEs | G1 n (%) |
G2 n (%) |
Treatment related AEs | G1 n (%) |
G2 n (%) |
| White blood cell count elevation | 1 (8) | Erythema | 4 (33) | ||
| Hypothyroidism | 1 (8) | Erythema non injected lesion | 1 (8) | ||
| Abdominal pain | 1 (8) | Fatigue | 1 (8) | ||
| Constipation | 3 (25) | Injection site itching | 1 (8) | ||
| Diarrhea | 2 (17) | Pruritus (generalized) | 1 (8) | ||
| Dyspepsia | 1 (8) | Tingling | 1 (8) | ||
| Anal fissure | 1 (8) | Skin infection | 1 (8) | ||
| Nausea | 1 (8) | Bruising | 1 (8) | ||
| Vomiting | 1 (8) | 1 (8) | Pruritus skin (localized) | 6 (50) | |
| Chills | 1 (8) | Discoloration injected lesion | 1 (8) | ||
| Erythema | 5 (42) | Hot flashes | 1 (8) | ||
| Erythema non-injected lesion | 1 (8) | ||||
| Edema limbs | 1 (8) | ||||
| Fatigue | 1 (8) | ||||
| Injection site itching | 1 (8) | ||||
| Pain | 2 (17) | ||||
| Pruritus (generalized) | 1 (8) | ||||
| Tingling | 1 (8) | ||||
| Vaginal infection | 2 (17) | ||||
| Skin infection | 1 (8) | ||||
| Urinary tract infection | 1 (8) | ||||
| Bruising | 2 (17) | ||||
| Bleeding | 1 (8) | ||||
| Biopsy site drainage | 2 (17) | ||||
| Tumor bleeding | 2 (17) | ||||
| Creatinine increase | 1 (8) | ||||
| Anorexia | 1 (8) | 2 (17) | |||
| Pain in extremity | 1 (8) | ||||
| Tumor pain | 1 (8) | 1 (8) | |||
| Dizziness | 1 (8) | ||||
| Headache | 1 (8) | ||||
| Cough | 2 (17) | ||||
| Nasal Congestion | 2 (17) | ||||
| Postnasal drip | 1 (8) | ||||
| Pruritus (localized) | 7 (58) | ||||
| Rash maculopapular | 2 (17) | ||||
| Lesion discoloration | 1 (8) | ||||
| Fever blister | 1 (8) | ||||
| Inflammation at biopsy site | 1 (8) | ||||
| Petechiae | 1 (8) | ||||
| Serosanguinous drainage | 1 (8) | ||||
| Soreness biopsy site | 1 (8) | ||||
| Hot flashes | 1 (8) |
AE, adverse event; G, grade.