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Table 2 Drug-related AEs developed in ≥ 2 patients as of data cut-off date

From: Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer

PT [SOC]a

Total

N = 12

Cohort 1

N = 3

Cohort 2

N = 3

Cohort 3

N = 3

Cohort 4

N = 3

G1

G2

G3

G4

G1

G2

G3

G4

G1

G2

G3

G4

G1

G2

G3

G4

G1

G2

G3

G4

Subjects with any drug-related AE

 

4

8

  

2

1

   

3

  

1

2

  

1

2

 

[Blood and lymphatic system disorders]

 Anemia

1

2

1

  

1

  

1

    

1

    

1

 

[Gastrointestinal disorders]

 Nausea

6

       

2

   

2

   

2

   

 Diarrhea

1

1

   

1

  

1

           

 Gastritis

2

       

1

       

1

   

[General disorders and administration site conditions]

 Fatigue

3

       

1

   

1

   

1

   

[Investigations]

 Neutrophil count decreased

 

5

3

  

2

1

  

1

1

  

1

   

1

1

 

 Platelet count decreased

4

1

2

 

2

   

1

 

1

 

1

    

1

1

 

 White blood cell count decreased

1

4

  

1

1

   

1

   

1

   

1

  

 Weight decreased

1

1

   

1

          

1

   

[Metabolism and nutrition disorders]

 Hypoalbuminemia

2

5

  

1

1

   

1

   

2

  

1

1

  

 Hypophosphatemia

 

1

4

       

2

  

1

1

   

1

 

 Decreased appetite

2

       

1

   

1

       

[Musculoskeletal and connective tissue disorders]

 Back pain

2

   

1

       

1

       

[Nervous system disorders]

 Headache

2

       

1

   

1

       

[Respiratory, thoracic and mediastinal disorders]

 Pneumonitis

2

   

1

           

1

   
  1. AE Adverse event, G Grade, PT Preferred Term, SOC System Organ Class
  2. aThe listing for AEs displaying the SOC and PT
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