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. Author manuscript; available in PMC: 2021 Oct 4.
Published in final edited form as: Clin Cancer Res. 2020 Sep 30;26(24):6417–6428. doi: 10.1158/1078-0432.CCR-20-1068

Table 3.

SAEs with suspected relationship to study treatment, by preferred term–all grades.

Preferred term Dose-escalation group 1 (fasting)
n = 41		 Dose-escalation group 2 (fed)
n = 42		 Dose-expansion group 1 (CDK4/6i-naïve)
n = 16		 Dose-expansion group 2 (CDK4/6i-refractory)
n = 17
Total 6 (14.6) 4 (9.5) 2 (12.5) 0
 Pneumonitis 1 (2.4) 0 2 (12.5) 0
 Pneumonia 1 (2.4) 0 0 0
 Anemia 1 (2.4) 1 (2.4) 0 0
 Abdominal pain 0 1 (2.4) 0 0
 Cellulitis 0 1 (2.4) 0 0
 Diarrhea 0 1 (2.4) 0 0
 Dyspnea 0 1 (2.4) 0 0
 Febrile neutropenia 1 (2.4) 0 0 0
 Lymphopenia 1 (2.4) 0 0 0
 Pneumocystis jirovecii infection 0 0 1 (6.3) 0
 Rash 1 (2.4) 0 0 0
 Renal failure 1 (2.4) 0 0 0
 Thrombocytopenia 1 (2.4) 0 0 0

Note: A patient with multiple occurrences of an SAE under one treatment is counted only once in the SAE category for that treatment.

SAEs occurring up to 30 days after the final study treatment administration were included.