Table 1.

Summary of key baseline characteristics of venetoclax studies

	Main cohort [n = 107]	Safety expansion [n = 51]	Ibrutinib failure [n = 43]	Idelalisib failure [n = 21]	Safety expansion [n = 41]	400 mg analysis set [n = 67]
Males	70 (65.4)	29 (56.9)	33 (76.7)	15 (71.4)	27 (65.9)	52 (77.6)
White	103 (97.2)	49 (96.1)	40 (93.0)	19 (90.5)	39 (95.1)	NR
Age ≥ 65 years	61 (57.0)	31 (60.8)	26 (60.5)	15 (71.4)	18 (43.9)	35 (52.2)
17p deletion
Present	72 (67.3)	44 (86.3)	21 (48.8)	2 (9.5)	20 (48.8)	14 (20.9)
Absent	2 (1.9)	1 (2.0)	NR	NR	NR	40 (59.7)
Indeterminate	6 (5.6)	1 (2.0)	NR	NR	NR	4 (6.0)
TP53 mutation
Present	61 (57.0)	32 (62.8)	15 (34.9)	1 (4.8)	11 (26.8)	14 (20.9)
Absent	17 (15.9)	9 (17.7)	NR	NR	NR	37 (55.2)
Indeterminate	6 (5.6)	1 (2.0)	NR	NR	NR	0
IGVH status
Present	8 (7.5)	5 (9.8)	4 (9.3)	2 (9.5)	11 (26.8)	NR
Absent	28 (26.2)	17 (33.3)	NR	NR	NR	NR
Binet stage at diagnosis
A	35 (32.7)	10 (19.6)	0 (0)	2 (9.5)	0 (0)	27 (40.3)
B	24 (22.4)	5 (9.8)	0 (0)	4 (19.1)	1 (2.4)	4 (6.0)
C	18 (16.8)	3 (5.9)	1 (2.3)	0 (0)	1 (2.4)	5 (7.5)
ECOG score
0	42 (39.3)	NR	13 (30.2)	5 (23.8)	16 (39.0)	31 (46.2)
1	56 (52.3)	NR	27 (62.8)	14 (66.7)	22 (53.7)	34 (50.8)
2	9 (8.4)	NR	3 (7.0)	2 (9.5)	3 (7.3)	0

Data are expressed as n (%)

Percentages were calculated by the ERG using the sample size as the denominator; where percentages do not total 100, this is due to missing data (although the ERG notes that by including missing data, the total sample size for staging in M14 is 109 rather than 105); percentages in the company submission were calculated using non-missing data

NR not reported, ECOG Eastern Cooperative Oncology Group, ERG Evidence Review Group, IGVH immunoglobulin heavy-chain variable-region