Table 3 Adverse events for the full patient cohort and each treatment group

From: A phase Ib study of entinostat plus lapatinib with or without trastuzumab in patients with HER2-positive metastatic breast cancer that progressed during trastuzumab treatment

Adverse Event

All Patients (N = 35)

Entinostat + Lapatinib + Trastuzumab (Patient: N = 21)

Entinostat + Lapatinib (Patient: N = 14)

All Grades N (%)

Grade 3-4 N (%)

All Grades N (%)

Grade 3-4 N (%)

All Grades N (%)

Grade 3-4 N (%)

Any Adverse Event

35 (100)

28 (80)

21 (100)

18 (85.7)

14 (100)

10 (71.4)

 Abdominal pain

2 (5.7)

2 (5.7)

1 (4.8)

1 (4.8)

1 (7.1)

1 (7.1)

 Alkaline phosphatase increased

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Anaemia

5 (14.3)

5 (14.3)

5 (23.8)

5 (23.8)

0 (0)

0 (0)

 Arthralgia

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Blood bilirubin increased

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Dehydration

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Diarrhoea

31 (88.6)

4 (11.4)

18 (85.7)

4 (19)

13 (92.9)

0 (0)

 Dyspnoea

3 (8.6)

3 (8.6)

0 (0)

0 (0)

3 (21.4)

3 (21.4)

 Fatigue

8 (22.6)

8 (22.6)

3 (14.3)

3 (14.3)

5 (35.7)

5 (35.7)

 Hyperglycaemia

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Hypocalcaemia

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Hypokalaemia

3 (8.6)

3 (8.6)

3 (14.3)

3 (14.3)

0 (0)

0 (0)

 Hyponatraemia

2 (5.7)

2 (5.7)

1 (4.8)

1 (4.8)

1 (7.1)

1 (7.1)

 Lung infection

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Myalgia

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Neoplasms benign, malignant and unspecified (incl cysts and polyps) - (Other), specifya

2 (5.7)

2 (5.7)

1 (4.8)

1 (4.8)

1 (7.1)

1 (7.1)

 Neutrophil count decreased

11 (31.4)

11 (31.4)

8 (38.1)

8 (38.1)

3 (21.4)

3 (21.4)

 Pain of skin

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Platelet count decreased

8 (22.6)

8 (22.6)

6 (28.6)

6 (28.6)

2 (14.3)

2 (14.3)

 Rash maculo-papular

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Sepsis

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Urinary tract infection

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 White blood cell decreased

3 (8.6)

3 (8.6)

3 (14.3)

3 (14.3)

0 (0)

0 (0)

Any Treatment-Related Adverse Event

34 (97.1)

28 (80)

20 (95.2)

18 (85.7)

14 (100)

10 (71.4)

 Abdominal pain

2 (5.7)

2 (5.7)

1 (4.8)

1 (4.8)

1 (7.1)

1 (7.1)

 Alkaline phosphatase increased

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Anaemia

5 (14.3)

5 (14.3)

5 (23.8)

5 (23.8)

0 (0)

0 (0)

 Arthralgia

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Blood bilirubin increased

1 (2.9)

1 (2.9)

1 (4.8)

0 (0)

0 (0)

0 (0)

 Dehydration

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Diarrhoea

31 (88.6)

4 (11.4)

18 (85.7)

4 (85.7)

13 (92.9)

0 (0)

 Dyspnoea

3 (8.6)

3 (8.6)

0 (0)

0 (0)

3 (21.4)

3 (21.4)

 Fatigue

8 (22.6)

8 (22.6)

3 (14.3)

3 (14.3)

5 (35.7)

5 (35.7)

 Hyperglycaemia

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Hypocalcaemia

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Hypokalaemia

3 (8.6)

3 (8.6)

3 (14.3)

3 (14.3)

0 (0)

0 (0)

 Hyponatraemia

2 (5.7)

2 (5.7)

1 (4.8)

1 (4.8)

1 (7.1)

1 (7.1)

 Lung infection

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Myalgia

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Neutrophil count decreased

11 (31.4)

11 (31.4)

8 (38.1)

8 (38.1)

3 (21.4)

3 (21.4)

 Pain of skin

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Platelet count decreased

8 (22.6)

8 (22.6)

6 (28.6)

6 (28.6)

2 (14.3)

2 (14.3)

 Rash maculo-papular

1 (2.9)

1 (2.9)

0 (0)

0 (0)

1 (7.1)

1 (7.1)

 Sepsis

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 Urinary tract infection

1 (2.9)

1 (2.9)

1 (4.8)

1 (4.8)

0 (0)

0 (0)

 White blood cell decreased

3 (8.6)

3 (8.6)

3 (14.3)

3 (14.3)

0 (0)

0 (0)

  1. aNeoplasms benign, malignant and unspecified: one in each arm is the only grade 5 adverse event that is unrelated with treatment
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