14 / 21
Integrated Safety Results:
Adverse Events Overview
Individual AE occurring in
≥20% of patients
†
Any grade,
% (n)
Grade 2,
% (n)
Grade 3,
% (n)
Grade 4,
% (n)
Nausea
76.9 (290)
23.6 (89)
5.0 (19)
0
Asthenia/fatigue
‡
76.7 (289)
36.3 (137) 10.9 (41)
0
Vomiting
46.2 (174)
13.0 (49)
4.0 (15)
0
Anaemia/haemoglobin
decreased
‡
43.8 (165)
10.3 (39)
23.3 (88)
1.6 (6)
ALT/AST increased
‡
41.4 (156)
11.9 (45)
10.6 (40)
0.3 (1)
Constipation
39.8 (150)
12.7 (48)
1.6 (6)
0
Decreased appetite
39.3 (148)
14.6 (55)
2.7 (10)
0
Dysgeusia
39.3 (148)
9.3 (35)
0.3 (1)
0
Diarrhoea
34.5 (130)
10.1 (38)
2.4 (9)
0
Abdominal pain
31.6 (119)
13.5 (51)
3.4 (13)
0
Dyspnoea
21.5 (81)
7.2 (27)
0.5 (2)
0
Thrombocytopenia/platelet
count decreased
‡
21.0 (79)
3.4 (13)
4.0 (15)
0.5 (2)
Blood creatinine increased 21.0 (79)
8.0 (30)
0.5 (2)
0
Oza AM et al.
Gynecol Oncol
. 2017;147:267–275
Summary of AEs
1
Integrated ovarian carcinoma safety population
(N=377)
†
% (n)
AE leading to dose modification
61.8 (233)
AE leading to dose reduction
45.9 (173)
AE leading to treatment
interruption
58.6 (221)
AE leading to treatment
discontinuation
‡
9.8 (37)
AE leading to death
2.4 (9)
Malignant neoplasm progression
2.1 (8)
Non-progression AE leading to
death
0.3 (1)