Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial

Table 1 Scores for the HRQL questionnaires at baseline

	Idelalisib/rituximab/bendamustine, N = 207	n	Placebo/rituximab/bendamustine, N = 209	n
FACT-Leu total score^a	125.27 (24.103)	196	123.17 (27.540)	202
Trial outcome index score^b	86.12 (18.662)	196	84.71 (21.337)	203
Physical well-being	21.77 (5.012)	197	21.39 (5.418)	203
Social/family well-being	21.51 (5.502)	198	21.40 (5.392)	203
Emotional well-being	17.68 (4.215)	198	16.93 (4.902)	204
Functional well-being	17.99 (6.068)	199	17.32 (6.135)	204
Leukemia-specific symptoms	46.31 (10.312)	199	45.95 (12.206)	204
EQ-5D utility index	0.78 (0.217)	197	0.78 (0.228)	195
EQ-VAS	68.8 (17.81)	190	67.4 (19.28)	194

Analyzed in the ITT population. All data presented as mean (SD); n indicates number of patients available for HRQL assessment at baseline
EQ-5D EuroQoL Five-Dimension, FACT-Leu functional assessment of cancer therapy–leukemia, EWB emotional well-being, FWB functional well-being, HRQL health-related quality of life, ITT intent-to-treat, LeuS leukemia-specific concerns, PWB physical well-being, S/FWB social/family well-being, SD standard deviation, TOI trial outcome index, VAS visual analog scale
^aFACT-Leu Total = LeuS + PWB + S/FWB + EWB + FWB
^bTOI = LeuS + PWB + FWB

ISSN: 1477-7525