Table 5.
Adverse event a | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | NC/NA, % |
---|---|---|---|---|---|---|---|
Injection site reaction | 16 | 0 | 0 | 0 | 0 | 16 | 38.5 |
Fatigue | 8 | 3 | 0 | 0 | 0 | 11 | 57.7 |
Fever | 7 | 2 | 0 | 0 | 0 | 9 | 65.4 |
Nausea | 1 | 2 | 0 | 0 | 0 | 3 | 88.5 |
Flu like symptoms | 3 | 0 | 0 | 0 | 0 | 3 | 88.5 |
Weight loss | 1 | 1 | 0 | 0 | 0 | 2 | 92.3 |
Malaise | 1 | 1 | 0 | 0 | 0 | 2 | 92.3 |
Anorexia | 1 | 1 | 0 | 0 | 0 | 2 | 92.3 |
Pain in extremity | 2 | 0 | 0 | 0 | 0 | 2 | 92.3 |
Neck pain | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Bone pain | 0 | 1 | 0 | 0 | 0 | 1 | 96.2 |
Erythema | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Aspartate aminotransferase increased | 0 | 1 | 0 | 0 | 0 | 1 | 96.2 |
Dyspnea | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Myalgia | 0 | 1 | 0 | 0 | 0 | 1 | 96.2 |
Rash | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Dizziness | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Edema limbs | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Alkaline phosphatase increased | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Venous stasis | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Blood bilirubin increased | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Diarrhea | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Headache | 1 | 0 | 0 | 0 | 0 | 1 | 96.2 |
Total | 51 | 13 | 0 | 0 | 0 | 64 |
Listed adverse events are possible, probable, or certainly related.
Abbreviation: NC/NA, no change from baseline/no adverse event.