Treatment-related adverse events, serious adverse events, and adverse events leading to dose reductions and dose interruptions (all patients treated, N = 55)
| . | n (%) . |
|---|---|
| Total number of patients with treatment-related AEs | 52 (94.5) |
| Treatment-related AEs (>10% incidence) | |
| Pyrexia | 32 (58.2) |
| Chills | 26 (47.3) |
| Hyperglycemia | 22 (40.0) |
| Dermatitis acneiform | 21 (38.2) |
| Fatigue | 19 (34.5) |
| Myalgia | 18 (32.7) |
| Aspartate aminotransferase increased | 18 (32.7) |
| Peripheral edema | 17 (30.9) |
| Nausea | 17 (30.9) |
| Rash, maculopapular | 16 (29.1) |
| Dry skin | 15 (27.3) |
| Alanine aminotransferase increased | 14 (25.5) |
| Blood alkaline phosphatase increased | 14 (25.5) |
| Headache | 14 (25.5) |
| Arthralgia | 11 (20.0) |
| Pain in extremity | 8 (14.5) |
| Blurred vision | 8 (14.5) |
| Vomiting | 7 (12.7) |
| Dry mouth | 7 (12.7) |
| Basal cell carcinoma | 7 (12.7) |
| Rash | 6 (10.9) |
| Diarrhea | 6 (10.9) |
| Treatment-related serious AEs | 19 (34.5) |
| Pyrexia | 7 (12.7) |
| Basal cell carcinoma | 3 (5.5) |
| Squamous cell carcinoma | 3 (5.5) |
| Squamous cell carcinoma of skin | 3 (5.5) |
| Chills | 2 (3.6) |
| Neutrophil count decreased | 1 (1.8) |
| Autoimmune hemolytic anemia | 1 (1.8) |
| Chronic lymphocytic leukemia | 1 (1.8) |
| Fat necrosis | 1 (1.8) |
| Metastatic squamous cell carcinoma | 1 (1.8) |
| Pulmonary granuloma | 1 (1.8) |
| Upper respiratory tract infection | 1 (1.8) |
| Bladder neoplasm | 1 (1.8) |
| Guillain-Barré syndrome | 1 (1.8) |
| Myocarditis | 1 (1.8) |
| Urinary tract infection | 1 (1.8) |
| AEs leading to dose reductions | 29 (52.7) |
| Most common AEs (>5% incidence) leading to dose reductions | |
| Pyrexia | 18 (32.7) |
| Chills | 14 (25.5) |
| Fatigue | 6 (10.9) |
| Rash, maculopapular | 4 (7.3) |
| Vomiting | 3 (5.5) |
| Myalgia | 3 (5.5) |
| Nausea | 3 (5.5) |
| Peripheral edema | 3 (5.5) |
| AEs leading to dose interruptions | 38 (69.1) |
| Most common AEs (>5% incidence) leading to dose interruptions | |
| Pyrexia | 18 (32.7) |
| Chills | 13 (23.6) |
| Fatigue | 6 (10.9) |
| Nausea | 3 (5.5) |
| Vomiting | 3 (5.5) |
| Diarrhea | 3 (5.5) |
| Headache | 3 (5.5) |
| Rash, maculopapular | 3 (5.5) |
| Vision blurred | 3 (5.5) |
| Constipation | 3 (5.5) |
| Dermatitis acneiform | 3 (5.5) |
| . | n (%) . |
|---|---|
| Total number of patients with treatment-related AEs | 52 (94.5) |
| Treatment-related AEs (>10% incidence) | |
| Pyrexia | 32 (58.2) |
| Chills | 26 (47.3) |
| Hyperglycemia | 22 (40.0) |
| Dermatitis acneiform | 21 (38.2) |
| Fatigue | 19 (34.5) |
| Myalgia | 18 (32.7) |
| Aspartate aminotransferase increased | 18 (32.7) |
| Peripheral edema | 17 (30.9) |
| Nausea | 17 (30.9) |
| Rash, maculopapular | 16 (29.1) |
| Dry skin | 15 (27.3) |
| Alanine aminotransferase increased | 14 (25.5) |
| Blood alkaline phosphatase increased | 14 (25.5) |
| Headache | 14 (25.5) |
| Arthralgia | 11 (20.0) |
| Pain in extremity | 8 (14.5) |
| Blurred vision | 8 (14.5) |
| Vomiting | 7 (12.7) |
| Dry mouth | 7 (12.7) |
| Basal cell carcinoma | 7 (12.7) |
| Rash | 6 (10.9) |
| Diarrhea | 6 (10.9) |
| Treatment-related serious AEs | 19 (34.5) |
| Pyrexia | 7 (12.7) |
| Basal cell carcinoma | 3 (5.5) |
| Squamous cell carcinoma | 3 (5.5) |
| Squamous cell carcinoma of skin | 3 (5.5) |
| Chills | 2 (3.6) |
| Neutrophil count decreased | 1 (1.8) |
| Autoimmune hemolytic anemia | 1 (1.8) |
| Chronic lymphocytic leukemia | 1 (1.8) |
| Fat necrosis | 1 (1.8) |
| Metastatic squamous cell carcinoma | 1 (1.8) |
| Pulmonary granuloma | 1 (1.8) |
| Upper respiratory tract infection | 1 (1.8) |
| Bladder neoplasm | 1 (1.8) |
| Guillain-Barré syndrome | 1 (1.8) |
| Myocarditis | 1 (1.8) |
| Urinary tract infection | 1 (1.8) |
| AEs leading to dose reductions | 29 (52.7) |
| Most common AEs (>5% incidence) leading to dose reductions | |
| Pyrexia | 18 (32.7) |
| Chills | 14 (25.5) |
| Fatigue | 6 (10.9) |
| Rash, maculopapular | 4 (7.3) |
| Vomiting | 3 (5.5) |
| Myalgia | 3 (5.5) |
| Nausea | 3 (5.5) |
| Peripheral edema | 3 (5.5) |
| AEs leading to dose interruptions | 38 (69.1) |
| Most common AEs (>5% incidence) leading to dose interruptions | |
| Pyrexia | 18 (32.7) |
| Chills | 13 (23.6) |
| Fatigue | 6 (10.9) |
| Nausea | 3 (5.5) |
| Vomiting | 3 (5.5) |
| Diarrhea | 3 (5.5) |
| Headache | 3 (5.5) |
| Rash, maculopapular | 3 (5.5) |
| Vision blurred | 3 (5.5) |
| Constipation | 3 (5.5) |
| Dermatitis acneiform | 3 (5.5) |