TABLE 2.

TEAEs by system organ class and grade

	CTCAE (V5) Grade
System organ class preferred term	Grade 1–2	Grade 3	Grade 4–5
Patient with any TEAE	28 (51.9%)	18 (33.3%)	7 (13.0%)
Blood and lymphatic system disorders	9 (16.7%)	3 (5.6%)	0
Anemia	10 (18.5%)	2 (3.7%)	0
Eye disorders	12 (22.2%)	0	0
Gastrointestinal disorders	35 (64.8%)	5 (9.3%)	0
Constipation	12 (22.2%)	0	0
Diarrhea	17 (31.5%)	0	0
Dry mouth	8 (14.8%)	0	0
Nausea	6 (11.1%)	0	0
Stomatitis	11 (20.4%)	0	0
General disorders and administration site conditions	18 (33.3%)	0	1 (1.9%)
Fatigue	11 (20.4%)	0	0
Infections and infestations	4 (7.4%)	4 (7.4%)	2 (3.7%)
Investigations	19 (35.2%)	2 (3.7%)	2 (3.7%)
Alanine aminotransferase increased	5 (9.3%)	1 (1.9%)	0
Aspartate aminotransferase increased	4 (7.4%)	2 (3.7%)	0
Blood creatinine increased	7 (13.0%)	0	0
Metabolism and nutrition disorders	30 (55.6%)	10 (18.5%)	0
Decreased appetite	6 (11.1%)	0	0
Hypercalcemia	5 (9.3%)	1 (1.9%)	0
Hyperphosphatemia	29 (53.7%)	8 (14.8%)	0
Musculoskeletal and connective tissue disorders	14 (25.9%)	1 (1.9%)	0
Nervous system disorders	7 (13.0%)	2 (3.7%)	1 (1.9%)
Psychiatric disorders	7 (13.0%)	0	0
Respiratory, thoracic, and mediastinal disorders	7 (13.0%)	1 (1.9%)	1 (1.9%)
Skin and subcutaneous tissue disorders	14 (25.9%)	0	0
Vascular disorders	5 (9.3%)	3 (5.6%)	0

Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; MedDRA = Medical Dictionary for Regulatory Activities; NCI = National Cancer Institute; TRAE = Treatment-Emergent Adverse Event.

NOTE: N represents the number of patients in the Safety Analysis Set in A1 Treatment and is the denominator for percentages. Patients having more than one TRAE within an SOC and PT are counted only once for that SOC/PT at their maximum CTCAE Grade. MedDRA Version 24.0. Grading was determined by Investigator assessment based on NCI-CTCAE, Version 5.0.