Table 3.

All Attributable Adverse Events (n = 18 Evaluable Patients)

	Adverse Events	Grade 1	Grade 2	Grade 3	Grade 4	Total Patients (%)
Blood and lymphatic system disorders	Anemia	9 (1a)	3	0	0	12 (67%)
Cardiac disordersb	Atrioventricular block (first degree)	1	0	0	0	1 (6%)
	Conduction disorder	0	0	0	1c	1 (6%)
	Supraventricular tachycardia	0	1	0	0	1 (6%)
	Ventricular arrhythmia	0	0	0	1c	1 (6%)
	Ventricular tachycardia	0	0	0	1c	1 (6%)
Gastrointestinal disorders	Abdominal pain	4	2	0	0	6 (33%)
	Anal mucositis	1	0	0	0	1 (6%)
	Constipation	2	0	0	0	2 (11%)
	Diarrhea	3	1	0	0	4 (22%)
	Dysphagia	0	1	0	0	1 (6%)
	Oral mucositis	10 (4a)	1a	1a	0	12 (67%)
	Oral dysesthesia	1	0	0	0	1 (6%)
	Oral pain	2a	0	0	0	2 (11%)
	Nausea	4	1	0	0	5 (28%)
	Stomach pain	0	1	0	0	1 (6%)
	Vomiting	4 (1b)	3	0	0	7 (39%)
General disorders	Fatigue	6 (1b)	7 (2b)	0	0	13 (72%)
	Feverb	1	0	0	0	1 (6%)
Infections and infestations	Lung infectiond	0	0	1a,e	0	1 (6%)
	Paronychiaa	0	1	0	0	1 (6%)
	Skin infection	1	1	0	0	2 (11%)
	Urinary tract infection	0	1	0	0	1 (6%)
Investigations	Alanine aminotransferase increased	4	2	2	0	8 (44%)
	Aspartate aminotransferase increased	7	2	0	0	9 (50%)
	Cholesterol high	11 (10a)	0	2a	0	13 (72%)
	Creatinine increased	3 (1b)	1	0	0	4 (22%)
	Ejection fraction decreased	1	0	0	0	1 (6%)
	Electrocardiogram QT corrected interval prolongedb	2	0	0	0	2 (11%)
	Electrocardiogram T wave abnormalb,d	0	1	0	0	1 (6%)
	Lymphocyte count decreased	6	7	2	0	15 (83%)
	Neutrophil count decreased	0	8	3	3	14 (78%)
	Platelet count decreased	4	0	0	0	4 (22%)
	Weight loss	1b	2	0	0	3 (17%)
	White blood cell count decreased	7	7	3	0	17 (94%)
Metabolism and nutrition disorders	Anorexia	3 (1b)	1b	0	0	4 (22%)
	Dehydration	1	0	0	0	1 (6%)
	Hyperglycemia	5 (4a)	0	0	0	5 (28%)
	Hypertriglyceridemiaa	7	1	1	0	9 (50%)
	Hypokalemia	1b	0	0	1c	2 (11%)
	Hypophosphatemia	6	2 (1b)	0	0	8 (44%)
Musculoskeletal and connective tissue disorders	Arthralgiaa	1a	0	0	0	1 (6%)
	Back paina	0	1a	0	0	1 (6%)
	Myalgiaa	1a	0	0	0	1 (6%)
	Neck pain	1	0	0	0	1 (6%)
	Pain in extremity	2 (1a;1b)	1a	0	0	3 (17%)
Nervous system disorders	Headache	3	3	0	0	6 (33%)
	Intracranial hemorrhage	1a	0	0	0	1 (6%)
Psychiatric disorders	Insomnia	1	1a	0	0	2 (11%)
Renal and urinary disorders	Glucosuriaa	1	0	0	0	1 (6%)
	Hematuriaa	2	0	0	0	2 (11%)
	Proteinuriaa	2	0	0	0	2 (11%)
	Urinary tract paina	1	0	0	0	1 (6%)
	Urinary urgencya	1	0	0	0	1 (6%)
	Urinary frequencya	0	1	0	0	1 (6%)
Reproductive system and breast disorders	Vaginal inflammationa	0	1	0	0	1 (6%)
Respiratory, thoracic, and mediastinal disorders	Cougha	1	1			2 (11%)
	Dyspepsiab	0	1	0	0	1 (6%)
	Dyspnea	1	0	0	0	1 (6%)
	Epistaxis	1	0	0	0	1 (6%)
Skin and subcutaneous tissue disorders	Alopeciab	2	0	0	0	2 (11%)
	Dry skina	0	2	0	0	2 (11%)
	Eczema	1	0	0	0	1 (6%)
	Hyperhidrosisa	1	0	0	0	1 (6%)
	Pruritus	1	0	0	0	1 (6%)
	Rash maculo-papularb	1	0	0	0	1 (6%)
Vascular disorders	Hypertension	0	5a	1b	0	6 (33%)

Abbreviations: AEs, adverse events; DLT, dose-limiting toxicities

^aEverolimus attribution;

^bRibociclib attribution;

^cDMT, DMT Dose Modifying Toxicity;

^dSerious;

^eDLT.

All AEs deemed attributable to study agents; reporting only the highest grade reported per participant during study treatment.