Table 2 AEs in Study 19: (a) episodes of any grade occurring after ≥ 2 years on treatment in > 7% of olaparib-arm patients in the overall population or BRCAm subgroup; (b) severity and impact of common AEs on treatment since the start of Study 19

From: Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy

(a)

Overall population

BRCAm patients

Patients on treatment ≥2 years, n (%), preferred term

Olaparib, n = 32

Placebo, n = 5

Olaparib, n = 21

Placebo, n = 5

Patients with any AE occurring after 2 years on treatment

24 (75)

4 (80)

16 (76)

4 (80)

 Fatigue/asthenia

6 (19)

0

4 (19)

0

 Constipation

5 (16)

0

4 (19)

0

 Pruritus

5 (16)

0

4 (19)

0

 Urinary tract infection

5 (16)

0

4 (19)

0

 Dizziness

5 (16)

0

3 (14)

0

 Dyspnoea

5 (16)

0

3 (14)

0

 Nausea

4 (13)

0

3 (14)

0

 Abdominal distension

4 (13)

0

3 (14)

0

 Back pain

4 (13)

0

3 (14)

0

 Upper respiratory tract infection

4 (13)

0

3 (14)

0

 Cough

4 (13)

0

2 (10)

0

 Pain in extremity

4 (13)

0

2 (10)

0

 Anaemiaa

3 (9)

0

3 (14)

0

 Bone pain

3 (9)

0

3 (14)

0

 Headache

3 (9)

1 (20)

2 (10)

1 (20)

 Peripheral swelling

3 (9)

0

2 (10)

0

 Blood creatinine increased

3 (9)

0

1 (5)

0

 Diarrhoea

3 (9)

0

1 (5)

0

 Sinusitis

3 (9)

0

1 (5)

0

 Vomiting

3 (9)

0

1 (5)

0

 Abdominal pain

2 (6)

1 (20)

2 (10)

1 (20)

 Alopecia

2 (6)

0

2 (10)

0

 Cystitis

2 (6)

0

2 (10)

0

 Ecchymosis

2 (6)

0

2 (10)

0

 Osteoarthritis

2 (6)

0

2 (10)

0

 Pancytopenia

2 (6)

0

2 (10)

0

 Pyrexia

2 (6)

0

2 (10)

0

 Sensory disturbance

2 (6)

0

2 (10)

0

 Sleep disorder

2 (6)

0

2 (10)

0

(b)

Nausea

Vomiting

Fatigue/asthenia

Anaemiaa

 

Olaparib

Placebo

Olaparib

Placebo

Olaparib

Placebo

Olaparib

Placebo

n

136

128

136

128

136

128

136

128

Patients with AEs

96 (71)

46 (36)

48 (35)

18 (14)

86 (63)

59 (46)

31 (23)

9 (7)

Patients whose first incidence occurred after >6 months on treatment

12 (9)

4 (3)

11 (8)

4 (3)

18 (13)

4 (3)

10 (7)

0

Total episodesb

129

58

92

20

118

72

40

10

 Grade 1

102 (79)

46 (79)

66 (72)

12 (60)

69 (58)

58 (81)

5 (13)

6 (60)

 Grade 2

24 (19)

12 (21)

23 (25)

7 (35)

37 (31)

10 (14)

24 (60)

3 (30)

 Grade 3 or 4

3 (2)

0

3 (3)

1 (5)

12 (10)

4 (6)

11 (28)

1 (10)

 Treatment interrupted

9 (7)

1 (2)

18 (20)

1 (5)

8 (7)

2 (3)

4 (10)

0

 Treatment dose reduced

5 (4)

0

4 (4)

1 (5)

9 (8)

1 (1)

8 (20)

1 (10)

 Treatment discontinued

1 (1)

1 (2)

0

0

0

0

0

0

 AE resolved

105 (81)

46 (79)

90 (98)

17 (85)

73 (62)

35 (49)

28 (70)

7 (70)

 Treatment required

56 (43)

10 (17)

21 (23)

3 (15)

5 (4)

3 (4)

30 (75)

2 (20)

Median time to onset of first event, days

4.0

13.0

52.0

64.5

28.0

29.0

29.0

92.0

Median duration of first event, months

2.7

0.8

0.1

0.1

3.0

3.3

2.8

0.5

  1. Arbitrary cut-off corresponding to three or more patients in the overall population, or two or more patients in the BRCAm subgroup
  2. All AEs reported after 2 years of treatment are included irrespective of whether this was the first incidence of a specific AE; incidences that began before 2 years, but that continued past 2 years on treatment are not included; no AEs were reported after 2 years by more than one patient in the placebo arm
  3. AE adverse event
  4. aIncludes patients with anaemia, haemoglobin decreased, red blood cell count decreased and haematocrit decreased
  5. bPatients could experience more than one episode of the AE
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