ALINA: Adverse events occurring in ≥10% of patients in either trial group¹

Adverse event, n (%)1,* Safety evaluable cohort	ALECENSA (n=128)		Chemotherapy (n=120)
	Any Grade	Grade 3 or 4	Any Grade	Grade 3 or 4
Any adverse event	126 (98.4)	38 (29.7)	112 (93.3)	37 (30.08)
Nausea	10 (7.8)	0	87 (72.5)	5 (4.2)
Creatine kinase increased	55 (43.0)	8 (6.2)	1 (0.8)	1 (0.8)
Constipation	54 (42.2)	1 (0.8)	30 (25.0)	1 (0.8)
Aspartate aminotransferase increased	53 (41.4)	1 (0.8)	6 (5.0)	0
Alanine aminotransferase increased	43 (33.6)	2 (1.6)	11 (9.2)	0
Blood bilirubin increased	43 (33.6)	2 (1.6)	1 (0.8)	0
Decreased appetite	7 (5.5)	0	35 (29.2)	1 (0.8)
COVID-19	37 (28.9)	0	1 (0.8)	0
Myalgia	36 (28.1)	1 (0.8)	2 (1.7)	0
Anaemia	30 (23.4)	0	31 (25.8)	1 (0.8)
Vomiting	9 (7.0)	0	30 (25.0)	2 (1.7)
Alkaline phosphatase increased	32 (25.0)	0	4 (3.3)	0
White blood cell count decreased	2 (1.6)	0	23 (19.2)	4 (3.3)
Neutrophil count decreased	3 (2.3)	0	21 (17.5)	12 (10.0)
Asthenia	14 (10.9)	0	19 (15.8)	3 (2.5)
Neutropenia	2 (1.6)	0	19 (15.8)	10 (8.3)
Creatinine increased	19 (14.8)	1 (0.8)	6 (5.0)	0
Cough	19 (14.8)	1 (0.8)	4 (3.3)	0
Fatigue	18 (14.1)	1 (0.8)	16 (13.3)	2 (1.7)
Rash	18 (14.1)	1 (0.8)	7 (5.8)	0
Malaise	6 (4.7)	0	16 (13.3)	0
Weight increased	17 (13.3)	1 (0.8)	1 (0.8)	0
Diarrhoea	16 (12.5)	1 (0.8)	10 (8.3)	1 (0.8)
Headache	14 (10.9)	0	8 (6.7)	0
Dyspnoea	13 (10.2)	1 (0.8)	3 (2.5)	0
Dysgeusia	13 (10.2)	0	3 (2.5)	0
Oedema, peripheral	13 (10.2)	0	1 (0.8)	0

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Adverse event, n (%)1,* Safety evaluable cohort	ALECENSA (n=128)
	Any Grade	Grade 3 or 4
Any adverse event	126 (98.4)	38 (29.7)
Nausea	10 (7.8)	0
Creatine kinase increased	55 (43.0)	8 (6.2)
Constipation	54 (42.2)	1 (0.8)
Aspartate aminotransferase increased	53 (41.4)	1 (0.8)
Alanine aminotransferase increased	43 (33.6)	2 (1.6)
Blood bilirubin increased	43 (33.6)	2 (1.6)
Decreased appetite	7 (5.5)	0
COVID-19	37 (28.9)	0
Myalgia	36 (28.1)	1 (0.8)
Anaemia	30 (23.4)	0
Vomiting	9 (7.0)	0
Alkaline phosphatase increased	32 (25.0)	0
White blood cell count decreased	2 (1.6)	0
Neutrophil count decreased	3 (2.3)	0
Asthenia	14 (10.9)	0
Neutropenia	2 (1.6)	0
Creatinine increased	19 (14.8)	1 (0.8)
Cough	19 (14.8)	1 (0.8)
Fatigue	18 (14.1)	1 (0.8)
Rash	18 (14.1)	1 (0.8)
Malaise	6 (4.7)	0
Weight increased	17 (13.3)	1 (0.8)
Diarrhoea	16 (12.5)	1 (0.8)
Headache	14 (10.9)	0
Dyspnoea	13 (10.2)	1 (0.8)
Dysgeusia	13 (10.2)	0
Oedema, peripheral	13 (10.2)	0

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Adverse event, n (%)1,* Safety evaluable cohort	Chemotherapy (n=120)
	Any Grade	Grade 3 or 4
Any adverse event	112 (93.3)	37 (30.08)
Nausea	87 (72.5)	5 (4.2)
Creatine kinase increased	1 (0.8)	1 (0.8)
Constipation	30 (25.0)	1 (0.8)
Aspartate aminotransferase increased	6 (5.0)	0
Alanine aminotransferase increased	11 (9.2)	0
Blood bilirubin increased	1 (0.8)	0
Decreased appetite	35 (29.2)	1 (0.8)
COVID-19	1 (0.8)	0
Myalgia	2 (1.7)	0
Anaemia	31 (25.8)	1 (0.8)
Vomiting	30 (25.0)	2 (1.7)
Alkaline phosphatase increased	4 (3.3)	0
White blood cell count decreased	23 (19.2)	4 (3.3)
Neutrophil count decreased	21 (17.5)	12 (10.0)
Asthenia	19 (15.8)	3 (2.5)
Neutropenia	19 (15.8)	10 (8.3)
Creatinine increased	6 (5.0)	0
Cough	4 (3.3)	0
Fatigue	16 (13.3)	2 (1.7)
Rash	7 (5.8)	0
Malaise	16 (13.3)	0
Weight increased	1 (0.8)	0
Diarrhoea	10 (8.3)	1 (0.8)
Headache	8 (6.7)	0
Dyspnoea	3 (2.5)	0
Dysgeusia	3 (2.5)	0
Oedema, peripheral	1 (0.8)	0

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