TABLE 3.
Summary of all AEs (N = 21, any grade incidence greater than 5%)
| Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
|---|---|---|---|---|---|
| Any events | 20 (95.2%) | 2 (15%) | 7 (35%) | 8 (40%) | 2 (10%) |
| Fatigue | 11 (52.4%) | 7 (33.3%) | 2 (9.5%) | 2 (9.5%) | 0 (0%) |
| Abdominal pain | 7 (33.3%) | 5 (23.8%) | 2 (9.5%) | 0 (0%) | 0 (0%) |
| Nausea | 7 (33.3%) | 4 (19%) | 3 (14.3%) | 0 (0%) | 0 (0%) |
| Edema limbs | 5 (23.8%) | 3 (14.3%) | 2 (9.5%) | 0 (0%) | 0 (0%) |
| Pain | 5 (23.8%) | 3 (14.3%) | 2 (9.5%) | 0 (0%) | 0 (0%) |
| Diarrhea | 4 (19%) | 3 (14.3%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Dyspnea | 4 (19%) | 1 (4.8%) | 1 (4.8%) | 2 (9.5%) | 0 (0%) |
| Skin and subcutaneous tissue disorders | 4 (19%) | 3 (14.3%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Anemia | 3 (14.3%) | 1 (4.8%) | 0 (0%) | 2 (9.5%) | 0 (0%) |
| Anorexia | 3 (14.3%) | 2 (9.5%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Chills | 3 (14.3%) | 3 (14.3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Constipation | 3 (14.3%) | 1 (4.8%) | 2 (9.5%) | 0 (0%) | 0 (0%) |
| Gastrointestinal disorders | 3 (14.3%) | 3 (14.3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Lung infection | 3 (14.3%) | 0 (0%) | 1 (4.8%) | 2 (9.5%) | 0 (0%) |
| Sinus tachycardia | 3 (14.3%) | 0 (0%) | 2 (9.5%) | 1 (4.8%) | 0 (0%) |
| Acute kidney injury | 2 (9.5%) | 0 (0%) | 0 (0%) | 2 (9.5%) | 0 (0%) |
| Back pain | 2 (9.5%) | 1 (4.8%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Dizziness | 2 (9.5%) | 1 (4.8%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Fall | 2 (9.5%) | 0 (0%) | 2 (9.5%) | 0 (0%) | 0 (0%) |
| Flank pain | 2 (9.5%) | 0 (0%) | 1 (4.8%) | 1 (4.8%) | 0 (0%) |
| Gastroesophageal reflux disease | 2 (9.5%) | 0 (0%) | 2 (9.5%) | 0 (0%) | 0 (0%) |
| Generalized muscle weakness | 2 (9.5%) | 1 (4.8%) | 0 (0%) | 1 (4.8%) | 0 (0%) |
| Headache | 2 (9.5%) | 2 (9.5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Insomnia | 2 (9.5%) | 1 (4.8%) | 0 (0%) | 1 (4.8%) | 0 (0%) |
| Localized edema | 2 (9.5%) | 2 (9.5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nasal congestion | 2 (9.5%) | 1 (4.8%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Neoplasm benign-maligant-unspecified (inc cyst-plyp) | 2 (9.5%) | 0 (0%) | 0 (0%) | 1 (4.8%) | 1 (4.8%) |
| Peripheral sensory neuropathy | 2 (9.5%) | 1 (4.8%) | 1 (4.8%) | 0 (0%) | 0 (0%) |
| Rash acneiform | 2 (9.5%) | 1 (4.8%) | 1 (4.8%) | 0 (0%) | 0 (0%) |