Table 1.

HRQoL Instrument Completion and Compliance Rates in the All-Comer Population.

Treatment visit	Category, rate %	EORTC QLQ-C30		EORTC QLQ-EN24a		EQ-5D-5L VAS
		L+P	TPC	L+P	TPC	L+P	TPC
		n = 388	n = 364	n = 388	n = 364	n = 388	n = 364
Baseline	Completion	95.4	96.4	79.6	82.7	96.6	97.8
	Compliance	95.9	96.7	80.1	82.9	97.2	98.1
Week 12	Completion	79.9	62.4	66.2	52.2	79.9	62.6
	Compliance	92.8	87.0	77.6	72.8	92.8	87.4
Week 24	Completion	59.8	24.5	49.0	20.9	59.8	24.7
	Compliance	88.9	73.6	72.8	63.3	88.9	74.4
Week 36	Completion	47.2	4.9	39.2	3.8	47.4	4.9
	Compliance	88.4	72.0	73.8	56.0	88.9	72.0

The completion rate at a specific timepoint was defined as the number of patients who completed at least one item at that specific timepoint divided by the number of patients in the HRQoL full analysis set. The compliance rate was defined as the number of patients who completed at least one item at the specific timepoint divided by the number of patients expected to complete the PRO assessment at that visit, not including patients missing by design (i.e. death, discontinuation, translation not available). Median duration of treatment (among patients in the safety analysis set; L+P: n = 406, TPC: n = 388) was 231 days in the L+P arm and 104.5 days in the TPC arm. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire; EORTC QLQ-EN24, EORTC QLQ-Endometrial, 24 questions; EQ-5D-5L, EuroQoL 5 dimensions, 5 levels; HRQoL, health-related quality of life; L+P, lenvatinib + pembrolizumab; PRO, patient-reported outcome; TPC, treatment of physician’s choice; VAS, visual analog scale.

^aTranslation of the EORTC QLQ-EN24 questionnaire was not available in some sites at the start of study enrolment, resulting in lower completion rates compared with the other questionnaires.