. 2020 Oct 20;26(1):e164–e172. doi: 10.1002/onco.13551

Table 4.

Safety results from SOLO‐1 and PAOLA‐1 trials

Trial name	Patient population	Maintenance treatment arms	Median time on therapy (months)	Discontinuations because of AE	All grade AEs	Grade 3–4 AEs	On treatment deaths
SOLO‐1 (n = 391)	BRCAm newly diagnosed advanced ovarian cancer	Olaparib vs. placebo	O: 24.6 P: 13.9	O: 12% P: 2%	O: 99% P: 92%	O: 30% P: 5%	No deaths because of AEs while on study drug or within 30 days after last dose in either arm
PAOLA‐1 (n = 806)	Newly diagnosed advanced ovarian cancer	O+B vs. P+B	O+B: 17.3 P+B: 15.6	O+B: 20% P+B: 6%	O+B: 99% P+B: 96%	O+B: 57% P+B: 50%	O+B: 1 death because of aplastic anemia/ pneumonia P+B: 4 deaths (2 myocardial infarction, 1 intestinal perforation, 1 cardiovascular failure)

Trial name

Patient population

Maintenance treatment arms

Median time on therapy (months)

Discontinuations because of AE

All grade AEs

Grade 3–4 AEs

On treatment deaths

SOLO‐1 (n = 391)

BRCAm newly diagnosed advanced ovarian cancer

Olaparib vs. placebo

O: 24.6

P: 13.9

O: 12%

P: 2%

O: 99%

P: 92%

O: 30%

P: 5%

No deaths because of AEs while on study drug or within 30 days after last dose in either arm

PAOLA‐1 (n = 806)

Newly diagnosed advanced ovarian cancer

O+B vs. P+B

O+B: 17.3

P+B: 15.6

O+B: 20%

P+B: 6%

O+B: 99%

P+B: 96%

O+B: 57%

P+B: 50%

O+B: 1 death because of aplastic anemia/ pneumonia

P+B: 4 deaths (2 myocardial infarction, 1 intestinal perforation, 1 cardiovascular failure)

Abbreviations: AE, adverse event; B, bevacizumab; BRCAm, BRCA mutated; O, olaparib; O+B, olaparib plus bevacizumab; P, placebo; P+B, placebo plus bevacizumab.