Table 3.

Treatment-emergent AEs in descending order of all grades in cohort 1 (safety population)

Cohort 1 prior platinum therapy (n = 48), n (%)Cohort 2 third-line treatment, no. prior platinum therapy (n = 35), n (%)
All gradesGrade 3Grade 4All gradesGrade 3Grade 4
Hematologica
Patients with treatment-emergent AE(s)33 (69)25 (52)3 (6)26 (74)17 (49)4 (11)
 Anemia24 (50)16 (33)020 (57)14 (40)0
 Thrombocytopenia23 (48)11 (23)3 (6)12 (34)4 (11)4 (11)
 Neutropenia15 (31)6 (13)016 (46)8 (23)0
 Leukopenia10 (21)1 (2)010 (29)3 (9)0
Nonhematologicb
Patients with treatment-emergent AE(s)47 (98)11 (23)2 (4)34 (97)10 (29)1 (3)
 Fatigue29 (60)3 (6)08 (23)00
 Nausea20 (42)2 (4)015 (43)00
 Diarrhea17 (35)1 (2)010 (29)00
 Decreased appetite11 (23)1 (2)09 (26)00
 Dyspnea11 (23)1 (2)1 (2)9 (26)2 (6)0
 Alopecia (grade 1)11 (23)007 (20)00
 Back pain11 (23)007 (20)00
 Vomiting10 (21)007 (20)00
 Pleural effusion4 (8)3 (6)04 (11)2 (6)0
  • NOTE: The category of thrombocytopenia incudes reports of thrombocytopenia and platelet count decreased. The category of neutropenia includes reports of neutropenia, decreased neutrophil count, and neutropenic sepsis. The category of anemia includes reports of anemia and hemoglobin decreased.

  • aAll treatment-emergent AEs in ≥15% of patients and grade 3 and 4 treatment-emergent AEs in ≥5% of patients. Transfusions: 1 patient with platelet transfusion and 23 patients (28%) with packed red blood cells (10 and 13 patients in cohorts 1 and 2, respectively). Hemorrhage: 1 patient had grade 3 hemorrhage (transient epistaxis). No patients had acute myeloid leukemia or myelodysplastic syndrome.

  • bAll treatment-emergent AEs in ≥20% of patients and grade ≥3 treatment-emergent AEs in ≥5% of patients. No grade 5 treatment-emergent AEs and no clinically significant cardiovascular toxicities were observed.