Table 2 Summary of AEs in the Asian subgroup and the global OlympiAD study population.

From: Olaparib monotherapy for Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer: OlympiAD randomized trial subgroup analysis

 

Asian subgroup

Global OlympiAD study population

Olaparib (N = 59)

Chemotherapy TPC (N = 27)

Olaparib (N = 205)

Chemotherapy TPC (N = 91)

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

Any AE

59 (100)

27 (45.8)

26 (96.3)

16 (59.3)

200 (97.6)

78 (38)

87 (95.6)

45 (49.5)

Nausea

32 (54.2)

0

11 (40.7)

0

119 (58.0)

0

32 (35.2)

1 (1.1)

Anaemia†

26 (44.1)

12 (20.3)

9 (33.3)

4 (14.8)

82 (40.0)

33 (16.1)

24 (26.4)

4 (4.4)

Neutropenia‡

5 (8.5)

1 (1.7)

7 (25.9)

4 (14.8)

56 (27.3)

19 (9.3)

45 (49.5)

24 (26.4)

Decreased WBC count

23 (39.0)

6 (10.2)

14 (51.9)

8 (29.6)

33 (16.1)

7 (3.4)

19 (20.9)

9 (9.9)

Vomiting

17 (28.8)

0

6 (22.2)

0

66 (32.2)

0

14 (15.4)

1 (1.1)

Increased ALT

16 (27.1)

1 (1.7)

7 (25.9)

1 (3.7)

24 (11.7)

3 (1.5)

16 (17.6)

1 (1.1)

Increased AST

13 (22.0)

2 (3.4)

8 (29.6)

0

20 (9.8)

5 (2.4)

15 (16.5)

0

Decreased appetite

11 (18.6)

0

7 (25.9)

0

35 (17.1)

0

11 (12.1)

0

Upper respiratory tract infection

10 (16.9)

1 (1.7)

6 (22.2)

0

27 (13.2)

1 (0.5)

9 (9.9)

0

Fatigue

10 (16.9)

0

1 (3.7)

0

61 (29.8)

7 (3.4)

22 (24.2)

1 (1.1)

Diarrhoea

9 (15.3)

0

6 (22.2)

0

42 (20.5)

1 (0.5)

20 (22.0)

0

Pyrexia

8 (13.6)

0

6 (22.2)

0

30 (14.6)

0

16 (17.6)

0

Headache

7 (11.9)

0

4 (14.8)

1 (3.7)

42 (20.5)

2 (1.0)

14 (15.4)

2 (2.2)

PPE syndrome

1 (1.7)

0

5 (18.5)

1 (3.7)

1 (0.5)

0

19 (20.9)

2 (2.2)

Dose reduction due to AEs, n (%)

10 (16.9)

—

8 (29.6)

—

52 (25.4)

—

28 (30.8)

—

Treatment interruption due to AEs, n (%)

17 (28.8)

—

6 (22.2)

—

74 (36.1)

—

26 (28.6)

—

Treatment discontinuations because of AEs, n (%)

4 (6.8)

—

2 (7.4)

—

10 (4.9)

—

7 (7.7)

—

  1. Most common AE of any grade occurring in ≥20% of Asian patients or the global OlympiAD study population in either treatment arm. AEs were graded using the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 4.0, and data were collected for the duration of study and the 30-day post-treatment follow-up period. Data cut-off 25 September 2017; †Anaemia includes anaemia, decreased haemoglobin level, decreased haematocrit, decreased red blood cell count and erythropenia; ‡Neutropenia includes febrile neutropenia, granulocytopenia, decreased granulocyte count, neutropenia, neutropenic sepsis, decreased neutrophil count and neutropenic infection. AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; PPE, palmar–plantar erythrodysesthesia; WBC, white blood cell.
Back to article page