Table 2.
AEs at least possibly related to treatment (includes all grade 3 and 4 toxicities, and any grade ≥10% toxicities).
| AE | Any grade (≥10%) or grade 3/4; or SAE N = 23 (%) | All ≥ grade 2 N = 23 (%) | All grade 3 N = 23 (%) | All grade 4 N = 23 (%) |
|---|---|---|---|---|
| Fatigue | 10 (43.5) | 3 (13.0) | ||
| CPK elevation | 23 (100) | 17 (73.9) | 10 (43.5) | 6 (26.1) |
| Edema/fluid retention | ||||
| Peripheral (limbs) | 14 (60.9) | 4 (17.4) | ||
| Facial | 10 (43.5) | 1 (4.3) | ||
| Periorbital | 8 (34.8) | 3 (13.0) | ||
| Weight gain/trunk | 5 (21.7) | 1 (4.3) | ||
| Skin-related | ||||
| Rash (acneiform) | 15 (65.2) | 5 (21.7) | ||
| Rash (maculopapular) | 15 (65.2) | 3 (13.0) | ||
| Palmar-plantar | 2 (8.7) | |||
| Erythrodysesthesia | 7 (30.4) | 1 (4.3) | ||
| Dry skin | 5 (21.7) | |||
| Pruritis | 3 (13.0) | 2 (8.7) | ||
| Skin infection | 1 (4.3) | |||
| Skin hypopigmentation | ||||
| Gastrointestinal-related | ||||
| Diarrhea | 12 (52.2) | 2 (8.7) | ||
| Nausea | 12 (52.2) | 1 (4.3) | ||
| Vomiting | 10 (43.5) | 2 (8.7) | ||
| Mucositis, oral | 7 (30.4) | |||
| Dyspepsia | 6 (26.1) | 1 (4.3) | ||
| Anorexia | 3 (13.0) | 1 (4.3) | ||
| Gastroparesis | 1 (4.3) | |||
| Dry mouth | 3 (13.0) | |||
| Cardiac/pulmonary-related | ||||
| Dyspnea | 3 (13.0) | |||
| Hypertension | 4 (17.4) | 2 (8.7) | ||
| Pleural effusion | 1 (4.3) | |||
| Musculoskeletal-related | ||||
| Myalgia | 3 (13.0) | |||
| Dropped head syndrome | 1 (4.3) | 1 (4.3) | ||
| Eye/ocular-related | ||||
| Blurred vision | 3 (13.0) | |||
| Retinopathy (subretinal fluid) | 3 (13.0) | |||
| Retinal vascular disorder (retinal vein occlusion) | 1 (4.3) | 1 (4.3) | 1 (4.3) | |
| Hematologic-related | ||||
| Anemia | 19 (82.6) | 7 (30.4) | 1 (4.3) | |
| White blood cell decreased | 7 (30.4) | 1 (4.3) | ||
| Lymphocyte count decreased | 6 (26.1) | 3 (13.0) | 2 (8.7) | |
| Neutrophil count decreased | 4 (17.4) | 3 (13.0) | ||
| Platelet count decreased | 15 (65.2) | 1 (4.3) | ||
| Renal/electrolytes-related | ||||
| Hypophosphatemia | 13 (56.5) | 9 (39.1) | 1 (4.3) | |
| Hypomagnesemia | 11 (47.8) | 1 (4.3) | ||
| Hypocalcemia | 13 (56.5) | 1 (4.3) | 1 (4.3) | |
| Hypokalemia | 4 (17.4) | 1 (4.3) | 1 (4.3) | |
| Hyperkalemia | 4 (17.4) | 1 (4.3) | ||
| Hypernatremia | 6 (26.1) | |||
| Creatinine increased | 5 (21.7) | 1 (4.3) | ||
| Liver-related | ||||
| ALT increased | 12 (52.2) | 1 (4.3) | ||
| AST increased | 22 (95.7) | 4 (17.4) | 2 (8.7) | |
| Alk phos increased | 8 (34.8) | 1 (4.3) | ||
| Blood bilirubin increased | 3 (13.0) | 1 (4.3) | ||
Note: Items in bold indicate SAEs requiring discontinuation of therapy.
Abbreviations: Alk phos, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase.