Table 3 Treatment-emergent adverse events (≥10%)a,b

From: Bireociclib plus fulvestrant for HR+/HER2- advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis

 

Bireociclib plus fulvestrant (n = 204)

Placebo plus fulvestrant (n = 101)

All grades

Grade 3

Grade 4

All grades

Grade 3

Grade 4

Any TEAE

204 (100)

111 (54.4)

16 (7.8)

94 (93.1)

15 (14.9)

1 (1.0)

Diarrhea

189 (92.6)

11 (5.4)

0

11 (10.9)

0

0

Neutropenia

178 (87.3)

55 (27.0)

9 (4.4)

14 (13.9)

1 (1.0)

1 (1.0)

Leukopenia

170 (83.3)

37 (18.1)

1 (0.5)

17 (16.8)

1 (1.0)

1 (1.0)

Anemia

136 (66.7)

22 (10.8)

0

13 (12.9)

0

0

Nausea

100 (49.0)

1 (0.5)

0

13 (12.9)

0

0

ALT increased

97 (47.5)

8 (3.9)

1 (0.5)

24 (23.8)

1 (1.0)

0

Vomiting

95 (46.6)

0

0

5 (5.0)

0

0

AST increased

87 (42.6)

7 (3.4)

0

30 (29.7)

0

1 (1.0)

Blood creatinine increased

85 (41.7)

2 (1.0)

0

5 (5.0)

0

0

Thrombocytopenia

73 (35.8)

7 (3.4)

1 (0.5)

6 (5.9)

0

0

Weight decreased

73 (35.8)

0

0

10 (9.9)

1 (1.0)

0

Decreased appetite

70 (34.3)

3 (1.5)

0

5 (5.0)

0

0

Hypertriglyceridemia

67 (32.8)

11 (5.4)

0

16 (15.8)

3 (3.0)

0

COVID-19

66 (32.4)

1 (0.5)

0

16 (15.8)

0

0

Hypercholesterolemia

63 (30.9)

0

0

11 (10.9)

0

0

Fatigue

61 (29.9)

4 (2.0)

0

12 (11.9)

0

0

Hypokalemia

59 (28.9)

14 (6.9)

3 (1.5)

6 (5.9)

1 (1.0)

0

Rash

49 (24.0)

2 (1.0)

0

1 (1.0)

0

0

Abdominal pain

46 (22.5)

2 (1.0)

0

3 (3.0)

0

0

Hyperuricemia

46 (22.5)

0

0

14 (13.9)

0

0

Urinary tract infection

42 (20.6)

1 (0.5)

0

13 (12.9)

0

0

Blood lactate dehydrogenase increased

39 (19.1)

0

0

8 (7.9)

0

0

Hypoproteinemia

38 (18.6)

0

0

7 (6.9)

0

0

Suspected COVID-19

30 (14.7)

0

0

15 (14.9)

0

0

γ-glutamyltransferase increased

28 (13.7)

2 (1.0)

0

12 (11.9)

3 (3.0)

0

Hyperglycemia

23 (11.3)

0

0

8 (7.9)

0

0

Lymphopenia

22 (10.8)

3 (1.5)

0

6 (5.9)

2 (2.0)

0

Blood creatine phosphokinase increased

21 (10.3)

1 (0.5)

0

1 (1.0)

0

0

  1. ALT alanine aminotransferase, AST aspartate aminotransferase, TEAE treatment-emergent adverse event.
  2. aData are presented as number (percentage) of patients unless otherwise indicated.
  3. bIn the BF group, there were 5 cases of grade 5 TEAEs, which included 1 case of death due to disease progression, 1 case of death due to unknown causes, 1 case of sudden cardiac death, 1 case of infectious pneumonia, and 1 case of respiratory distress. In the F group, there were 3 cases of grade 5 TEAEs, which included 2 cases of death due to disease progression and 1 case of organ failure. All these death were identified unrelated with trial drug per investigator.