Table 3.

Serious Adverse events (classified by SOC) - maximum grade per cycle

		Olaparib (n = 32)			Placebo (n = 27)
		Grade			Grade
AE soc	ae_term	3	4	5	2	3
Blood and lymphatic system disorders	Anemia	1(3%)	1(3%)
Gastrointestinal disorders	Diarrhea	1(3%)
	Rectal fistula					1(4%)
	Vomiting	1(3%)
	Intestinal stoma obstruction		1(3%)
Infections and infestations	Lung infection	2(6%)		1(3%)
	Sepsis	1(3%)		1(3%)
	Upper respiratory infection	1(3%)
	Urinary tract infection	1(3%)
	Vascular disorders - Other, specify					1(4%)
Investigations	Creatinine increased				1(4%)
Musculoskeletal and connective tissue disorders	Pain					1(4%)
Nervous system disorders	Edema cerebral	1(3%)
	Headache					1(4%)
	Stroke				1(4%)
	Nervous system disorders - Other, specify	1(3%)
Renal and urinary disorders	Acute kidney injury	1(3%)
Respiratory, thoracic and mediastinal disorders	Infections and infestations - Other, specify					1(4%)
	Dyspnea	1(3%)
Vascular disorders	Thromboembolic event					1(4%)
	Vascular disorders - Other, specify	1(3%)