Table 3a.

a. Adverse events ≥ grade 3 in the first 90 days from the start of concurrent treatment (acute)

System Organ Class	Term	Grade	Relationship to Treatment	Days from Concurrent RX start
Nervous system disorders	Headache	3	Probable	78
General disorders and administration site conditions	Fatigue	3	Probable	85
Nervous system disorders	Syncope	3	Possible	89
Vascular disorders	Thromboembolic event*	4	Probable	42
Metabolism and nutrition disorders	Hyponatremia	3	Probable	55
	Hyperglycemia	3	Possible	90
Infections and infestations	Vaginal infection	3	Probable	28
Reproductive system and breast disorders	Vaginal inflammation	3	Possible	27
Investigations	Alanine aminotransferase increased	3	Possible	12
Blood and lymphatic system disorders	Febrile neutropenia	4	Probable	88
General disorders and administration site conditions	Fatigue	3	Possible	4