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 2 Summary of symptom improvement

	Idelalisib/bendamustine/rituximab, N = 207			Placebo/bendamustine/rituximab, N = 209
	Patients with MID improvement^a	Time to symptom improvement^b	Proportion of patients with any symptom improvement^c	Patients with MID improvement^a	Time to symptom improvement^b	Proportion of patients with any symptom improvement^c	HR (95% CI)	P-value
PWB	97 (69.3)	12.3 (9.1, 16.1) N = 140	139 (67.1)	89 (61.8)	20.9 (12.9, 30.1) N = 144	141 (67.5)	1.28 (0.96, 1.70)	0.1026
S/FWB	82 (59.0)	20.4 (12.1, 39.9) N = 139	130 (62.8)	79 (52.7)	32.4 (16.3, 72.7) N = 150	139 (66.5)	1.20 (0.88, 1.63)	0.2663
EWB	99 (62.7)	16.1 (8.9, 23.9) N = 158	159 (76.8)	103 (61.7)	16.9 (12.4, 24.4) N = 167	147 (70.3)	1.04 (0.79, 1.37)	0.8357
FWB	102 (60.0)	20.9 (12.1, 39.9) N = 170	142 (68.6)	100 (55.2)	24.7 (16.1, 44.3) N = 181	145 (69.4)	1.07 (0.81, 1.42)	0.6321
LeuS	142 (74.7)	8.4 (6.3, 12.7) N = 190	168 (81.2)	133 (68.6)	12.3 (11, 16.3) N = 194	168 (80.4)	1.22 (0.96, 1.55)	0.1134

Analyzed in the ITT population. Patients with baseline PWB/S/FWB/FWB > 25, EWB > 21, and LeuS > 63 are not included in the respective analysis of improvement
CI confidence interval, EWB emotional well-being, FWB functional well-being, HRQL health-related quality of life, HR hazard ratio, ITT intent-to-treat, LeuS leukemia-specific concerns, MID minimally important difference, PWB physical well-being, S/FWB social/family well-being
^aData presented as n (%). MID symptom improvement was defined as an increase of ≥3 points from baseline for PWB/S/FWB/FWB/EWB and 5 points for LeuS
^bData presented as median (95% CI), weeks. Patients who did not experience a symptom improvement compared to baseline were censored at their last available HRQL assessment time. Time to symptom improvement (weeks) = (date of first symptom improvement − date of randomization + 1)/7
^cData presented as n (%). Patients with any increase from baseline

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