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Table 2 Summary of treatment-related adverse events (TRAE) in all grades of severity

From: Selinexor in combination with standard chemotherapy in patients with advanced or metastatic solid tumors

N (%)

Selinexor 60 mg QW/BIW  +  carboplatin 6 AUC Q3W (N  = 6)

Selinexor 60 mg QW/BIW  +  doxorubicin 60 mg/m2  +  cyclophosphamide 600 mg/m2 Q3W (N  = 4)

Selinexor 40 mg QW  +  FOLFIRIa (N  = 3)

Selinexor 60 mg QW  +  irinotecan 125 mg/m2 D1 and 8 Q3W (N  = 3)

Selinexor 40 mg QW  +  XELOXb (N  = 3)

All patients (N  = 19)

All grades

Grade 3/4

All grades

Grade 3/4

All grades

Grade 3/4

All grades

Grade 3/4

All grades

Grade 3/4

All grades

Grade 3/4

Anemia

5 (83)

2 (33)

2 (50)

0

1 (33)

0

1 (33)

0

1 (33)

1 (33)

10 (53)

3 (16)

Leukopenia

4 (75)

1 (17)

3 (75)

3 (75)

3 (100)

0

1 (33)

0

2 (67)

1 (33)

13 (68)

5 (26)

Neutropenia

4 (75)

2 (33)

3 (75)

3 (75)

2 (67)

1 (33)

2 (67)

1 (33)

1 (33)

1 (33)

12 (63)

8 (42)

Thrombocytopenia

6 (100)

3 (50)

3 (75)

0

2 (67)

0

2 (67)

0

3 (100)

0

16 (84)

3 (16)

Constipation

0

0

0

0

0

0

0

0

0

0

0

0

Diarrhea

2 (33)

0

0

0

0

0

1 (33)

0

1 (33)

1 (33)

4 (21)

1 (5)

Nausea

4 (75)

0

4 (100)

0

1 (33)

0

1 (33)

0

3 (100)

0

13 (68)

0

Vomiting

4 (75)

0

3 (75)

0

0

0

1 (33)

0

2 (67)

0

10 (53)

0

Elevated AST/ALT

0

0

0

0

1 (33)

0

1 (33)

0

0

0

2 (11)

0

Mucositis

0

0

0

0

0

0

0

0

0

0

0

0

Fatigue

4 (75)

0

2 (50)

0

1 (33)

0

3 (100)

1 (33)

1 (33)

0

11 (58)

1 (5)

Anorexia

1 (17)

0

0

0

0

0

1 (33)

0

2 (67)

0

4 (21)

0

Hyponatremia

3 (50)

2 (33)

0

0

1 (33)

1 (33)

1 (33)

0

1 (33)

1 (33)

6 (32)

4 (21)

Hypomagnesemia

1 (17)

0

0

0

0

0

0

0

1 (33)

0

2 (11)

0

Hypoalbuminemia

0

0

0

0

0

0

0

0

0

0

0

0

Dyspnea

0

0

0

0

0

0

0

0

1 (33)

0

1 (5)

0

Cough

0

0

0

0

0

0

0

0

0

0

0

0

Elevated CPK

1 (17)

0

0

0

0

0

0

0

0

0

1 (5)

0

Infection or infestation

0

0

0

0

0

0

0

0

0

0

0

0

Elevated lipase

1 (17)

1 (17)

0

0

0

0

0

0

0

0

1 (5)

1 (5)

  1. aFOLFIRI—irinotecan of 180 mg/m2, 5-FU continuous infusion of 2400 mg/m2, 5-FU bolus of 400 mg/m2, and leucovorin of 400 mg/m2 on days 1, and 15
  2. bXELOX—capecitabine was dosed at 900 mg/m2 orally (PO) divided into 2 doses on days 1–14, along with oxaliplatin of 130 mg/m2 IV Q3W
  3. QW once weekly; BIW twice weekly; AUC area under curve; mg/m2 milligrams per square meter; D1 and 8 on days 1, and 8 of each cycle; Q3W every 3 weeks; ALT alanine aminotransferase; AST aspartate aminotransferase; CPK creatine phosphokinase; FOLFIRI irinotecan with fluorouracil and folinic acid; 5-FU 5-fluorouracil; XELOX capecitabine and oxaliplatin