SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy
Table 2
All adverse events regardless of attribution (N = 20 patients).
Adverse events, n (%)
Grade 1
Grade 2
Grade 3
Grade 4
Anemia
1 (5)
4 (20)
5 (25)
1 (5)
Fatigue
5 (25)
5 (25)
3 (15)
Neutropenia
6 (30)
3 (15)
Thrombocytopenia
3 (15)
2 (10)
Peripheral sensory neuropathy
1 (5)
2 (10)
Lymphopenia
1 (5)
2 (10)
Diarrhea
3 (15)
1 (5)
Decreased ejection fraction
1 (5)
Hypokalemia
1 (5)
Pneumonia
1 (5)
Noncardiac chest pain
1 (5)
Pain
1 (5)
Pericardial effusion
1 (5)
Pericardial tamponade
1 (5)
Pericarditis
1 (5)
Pulmonary embolism
1 (5)
Syncope
1 (5)
Vomiting
4 (20)
1 (5)
Leukopenia
1 (5)
2 (10)
Biopsy-related bleeding
1 (5)
Grade 3 pericardial effusion, tamponade, and pericarditis all occurred in the same patient.