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Table 3 Most common adverse events (occurring in ≥15% of patients), regardless of study drug relationship

From: Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2 breast cancer that had progressed during or after prior endocrine therapy

Adverse events occurring in ≥ 15% of patients, by preferred term, n (%)

Dovitinib + fulvestrant (n = 47)

Placebo + fulvestrant (n = 50)

Any grade

Grade 3a

Any grade

Grade 3a

Any adverse event

47 (100)

32 (68.1)

47 (94.0)

19 (38.0)

Diarrhea

37 (78.7)

7 (14.9)

16 (32.0)

2 (4.0)

Nausea

34 (72.3)

4 (8.5)

11 (22.0)

1 (2.0)

Vomiting

27 (57.4)

3 (6.4)

4 (8.0)

0

Asthenia

18 (38.8)

4 (8.5)

11 (22.0)

1 (2.0)

Headache

17 (36.2)

2 (4.3)

3 (6.0)

0

Fatigue

16 (34.0)

6 (12.8)

13 (26.0)

1 (2.0)

Rash

16 (34.0)

1 (2.1)

3 (6.0)

0

Alanine aminotransferase increase

15 (31.9)

7 (14.9)

5 (10.0)

1 (2.0)

Dysgeusia

15 (31.9)

0

1 (2.0)

0

Decreased appetite

13 (27.7)

2 (4.3)

8 (16.0)

0

Hypertension

13 (27.7)

10 (21.3)

4 (8.0)

3 (6.0)

Dyspepsia

12 (25.5)

0

0

0

Blood alkaline phosphatase increase

11 (23.4)

6 (12.8)

1 (2.0)

0

Aspartate aminotransferase increase

10 (21.3)

3 (6.4)

4 (8.0)

1 (2.0)

Abdominal pain upper

10 (21.3)

0

3 (6.0)

0

Stomatitis

10 (21.3)

0

2 (4.0)

0

Anemia

9 (19.1)

2 (4.3)

4 (8.0)

1 (2.0)

γ-Glutamyltransferase increase

9 (19.1)

5 (10.6)b

4 (8.0)

3 (6.0)b

Pain in extremity

9 (19.1)

0

3 (6.0)

0

Dry skin

9 (19.1)

0

2 (4.0)

0

Dyspnea

8 (17.0)

1 (2.1)

6 (12.0)

0

Abdominal pain

8 (17.0)

0

5 (10.0)

0

Constipation

8 (17.0)

0

5 (10.0)

0

Hypertriglyceridemia

8 (17.0)

4 (8.5)

1 (2.0)

0

  1. aGrade 4 adverse events occurred in eight patients (17.0%) in the dovitinib + fulvestrant arm and six patients (12.0%) in the placebo + fulvestrant arm, but no grade 4 adverse events were reported for any of the most common adverse events (occurring in ≥15% of patients), except where noted
  2. bGrade 4 γ-glutamyltransferase increase was reported in three patients (6.4%) in the dovitinib + fulvestrant arm and one patient (2.0%) in the placebo + fulvestrant arm