Table 2 Most frequent AEs in the Chinese cohort overall population (safety population)^a

From: Capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer: phase 3 CAPItello-291 study extended Chinese cohort

AE, n (%)	Capivasertib–fulvestrant (n = 71)						Placebo–fulvestrant (n = 62)
AE, n (%)	Any grade	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5	Any grade	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Any AE	67 (94.4)	12 (16.9)	20 (28.2)	31 (43.7)	3 (4.2)	1 (1.4)^b	56 (90.3)	19 (30.6)	29 (46.8)	6 (9.7)	2 (3.2)	0
Diarrhea	43 (60.6)	29 (40.8)	9 (12.7)	5 (7.0)	0	0	7 (11.3)	7 (11.3)	0	0	0	0
Hyperglycemia	41 (57.7)	30 (42.3)	10 (14.1)	0	1 (1.4)	0	11 (17.7)	11 (17.7)	0	0	0	0
Rash^c	36 (50.7)	13 (18.3)	12 (16.9)	11 (15.5)	0	0	6 (9.7)	4 (6.5)	2 (3.2)	0	0	0
Anemia	22 (31.0)	10 (14.1)	10 (14.1)	2 (2.8)	0	0	12 (19.4)	6 (9.7)	5 (8.1)	1 (1.6)	0	0
Hypokalemia	18 (25.4)	13 (18.3)	1 (1.4)	4 (5.6)	0	0	6 (9.7)	2 (3.2)	1 (1.6)	3 (4.8)	0	0
Weight decreased	17 (23.9)	12 (16.9)	5 (7.0)	0	0	0	3 (4.8)	2 (3.2)	0	1 (1.6)	0	0
Hypertriglyceridemia	16 (22.5)	9 (12.7)	4 (5.6)	3 (4.2)	0	0	4 (6.5)	4 (6.5)	0	0	0	0
Pyrexia	16 (22.5)	9 (12.7)	7 (9.9)	0	0	0	3 (4.8)	3 (4.8)	0	0	0	0
Urinary tract infection	15 (21.1)	4 (5.6)	10 (14.1)	1 (1.4)	0	0	12 (19.4)	3 (4.8)	9 (14.5)	0	0	0
White blood cell count decreased	15 (21.1)	4 (5.6)	10 (14.1)	1 (1.4)	0	0	5 (8.1)	3 (4.8)	2 (3.2)	0	0	0
Neutrophil count decreased	14 (19.7)	6 (8.5)	6 (8.5)	2 (2.8)	0	0	4 (6.5)	3 (4.8)	1 (1.6)	0	0	0
Alanine aminotransferase increased	13 (18.3)	12 (16.9)	0	1 (1.4)	0	0	21 (33.9)	18 (29.0)	3 (4.8)	0	0	0
Glycosylated hemoglobin increased	13 (18.3)	13 (18.3)	0	0	0	0	3 (4.8)	3 (4.8)	0	0	0	0
Proteinuria	12 (16.9)	11 (15.5)	1 (1.4)	0	0	0	5 (8.1)	4 (6.5)	1 (1.6)	0	0	0
Nausea	11 (15.5)	8 (11.3)	2 (2.8)	1 (1.4)	0	0	2 (3.2)	2 (3.2)	0	0	0	0
Aspartate aminotransferase increased	10 (14.1)	9 (12.7)	1 (1.4)	0	0	0	18 (29.0)	14 (22.6)	3 (4.8)	1 (1.6)	0	0
COVID-19	10 (14.1)	5 (7.0)	5 (7.0)	0	0	0	5 (8.1)	5 (8.1)	0	0	0	0
Hypophosphatemia	9 (12.7)	8 (11.3)	1 (1.4)	0	0	0	3 (4.8)	3 (4.8)	0	0	0	0
Stomatitis	9 (12.7)	5 (7.0)	4 (5.6)	0	0	0	0	0	0	0	0	0
Blood creatinine increased	8 (11.3)	4 (5.6)	4 (5.6)	0	0	0	2 (3.2)	2 (3.2)	0	0	0	0
Blood thyroid stimulating hormone increased	8 (11.3)	8 (11.3)	0	0	0	0	5 (8.1)	5 (8.1)	0	0	0	0
Decreased appetite	8 (11.3)	6 (8.5)	2 (2.8)	0	0	0	3 (4.8)	1 (1.6)	2 (3.2)	0	0	0
Hypercholesterolemia	8 (11.3)	7 (9.9)	1 (1.4)	0	0	0	4 (6.5)	4 (6.5)	0	0	0	0
Hypoalbuminemia	8 (11.3)	7 (9.9)	1 (1.4)	0	0	0	7 (11.3)	5 (8.1)	2 (3.2)	0	0	0
Hypocalcemia	8 (11.3)	4 (5.6)	4 (5.6)	0	0	0	3 (4.8)	3 (4.8)	0	0	0	0
Vomiting	8 (11.3)	6 (8.5)	0	2 (2.8)	0	0	3 (4.8)	3 (4.8)	0	0	0	0

AE adverse event, COVID-19 coronavirus disease 2019.
^aThe safety population included all the patients who received at least one dose of capivasertib, fulvestrant or placebo. The listed AEs were reported as a single term in at least 10% of the patients for any grade in either group. AEs are reported regardless of the relationship to the study drugs. ^bDeath from renal failure not considered by the investigator to be related to capivasertib or fulvestrant. Renal failure is not included in the table as a preferred term, as the frequency of AEs of any grade was below the threshold of at least 10% in either group (n = 2 [2.8%] in the capivasertib–fulvestrant group; n = 0 in the placebo–fulvestrant group). ^cGroup term of rash includes the preferred terms of rash, rash macular, rash maculopapular, rash papular and rash pruritic.

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Table 2 Most frequent AEs in the Chinese cohort overall population (safety population)^a

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