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NCT02684006 · OUTCOME

Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)

What was measured

EQ-5D-5L is a 5-item participant-completed questionnaire designed to assess health status in terms of a single utility score. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. Published UK weights were used to create a single summary utility score. Utility scores range from -0.594 to 1, with higher scores representing better health status.

Analysis population: FAS included all randomized participants. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable for the specified rows.

Groups in this outcome

Avelumab + Axitinib

Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.

Sunitinib

Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	442
Sunitinib	444

Reported measurements

Cycle 2 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	381
Sunitinib	355

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.034	0.1743	Not reported	Not reported	Not reported
Sunitinib	0.001	0.1632	Not reported	Not reported	Not reported

Cycle 3 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	356
Sunitinib	317

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.023	0.1826	Not reported	Not reported	Not reported
Sunitinib	-0.017	0.1804	Not reported	Not reported	Not reported

Cycle 4 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	335
Sunitinib	283

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.029	0.1829	Not reported	Not reported	Not reported
Sunitinib	-0.022	0.1667	Not reported	Not reported	Not reported

Cycle 5 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	324
Sunitinib	260

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.019	0.1622	Not reported	Not reported	Not reported
Sunitinib	-0.016	0.1826	Not reported	Not reported	Not reported

Cycle 6 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	300
Sunitinib	229

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.025	0.1787	Not reported	Not reported	Not reported
Sunitinib	-0.003	0.1967	Not reported	Not reported	Not reported

Cycle 7 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	276
Sunitinib	202

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.018	0.1651	Not reported	Not reported	Not reported
Sunitinib	0.008	0.1618	Not reported	Not reported	Not reported

Cycle 8 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	264
Sunitinib	177

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.029	0.1848	Not reported	Not reported	Not reported
Sunitinib	0.002	0.1731	Not reported	Not reported	Not reported

Cycle 9 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	249
Sunitinib	155

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.029	0.2021	Not reported	Not reported	Not reported
Sunitinib	-0.011	0.1662	Not reported	Not reported	Not reported

Cycle 10 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	236
Sunitinib	152

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.025	0.1935	Not reported	Not reported	Not reported
Sunitinib	-0.018	0.1617	Not reported	Not reported	Not reported

Cycle 11 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	228
Sunitinib	138

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.020	0.1854	Not reported	Not reported	Not reported
Sunitinib	0.004	0.1642	Not reported	Not reported	Not reported

Cycle 12 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	209
Sunitinib	123

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.026	0.1875	Not reported	Not reported	Not reported
Sunitinib	-0.016	0.1712	Not reported	Not reported	Not reported

Cycle 13 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	208
Sunitinib	111

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.026	0.1777	Not reported	Not reported	Not reported
Sunitinib	-0.017	0.1549	Not reported	Not reported	Not reported

Cycle 14 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	197
Sunitinib	102

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.036	0.1938	Not reported	Not reported	Not reported
Sunitinib	-0.006	0.1600	Not reported	Not reported	Not reported

Cycle 15 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	192
Sunitinib	102

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.036	0.1892	Not reported	Not reported	Not reported
Sunitinib	0.018	0.1487	Not reported	Not reported	Not reported

Cycle 16 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	175
Sunitinib	95

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.044	0.1757	Not reported	Not reported	Not reported
Sunitinib	0.020	0.1663	Not reported	Not reported	Not reported

Cycle 17 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	168
Sunitinib	89

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.050	0.1950	Not reported	Not reported	Not reported
Sunitinib	-0.000	0.1675	Not reported	Not reported	Not reported

Cycle 18 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	160
Sunitinib	81

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.040	0.1667	Not reported	Not reported	Not reported
Sunitinib	-0.027	0.1765	Not reported	Not reported	Not reported

Cycle 19 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	148
Sunitinib	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.059	0.1959	Not reported	Not reported	Not reported
Sunitinib	0.003	0.1665	Not reported	Not reported	Not reported

Cycle 20 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	143
Sunitinib	71

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.050	0.1942	Not reported	Not reported	Not reported
Sunitinib	0.001	0.1538	Not reported	Not reported	Not reported

Cycle 21 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	135
Sunitinib	67

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.048	0.1902	Not reported	Not reported	Not reported
Sunitinib	-0.004	0.1904	Not reported	Not reported	Not reported

Cycle 22 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	129
Sunitinib	60

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0.037	0.1919	Not reported	Not reported	Not reported
Sunitinib	0.002	0.1561	Not reported	Not reported	Not reported

Cycle 23 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	118
Sunitinib	58

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.033	0.2021	Not reported	Not reported	Not reported
Sunitinib	-0.028	0.1729	Not reported	Not reported	Not reported

Cycle 24 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	116
Sunitinib	54

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.036	0.1982	Not reported	Not reported	Not reported
Sunitinib	0.004	0.1618	Not reported	Not reported	Not reported

Cycle 25 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	112
Sunitinib	54

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.019	0.1825	Not reported	Not reported	Not reported
Sunitinib	-0.007	0.1678	Not reported	Not reported	Not reported

Cycle 26 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	111
Sunitinib	48

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.039	0.1927	Not reported	Not reported	Not reported
Sunitinib	-0.009	0.1471	Not reported	Not reported	Not reported

Cycle 27 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	107
Sunitinib	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.046	0.2233	Not reported	Not reported	Not reported
Sunitinib	0.014	0.1492	Not reported	Not reported	Not reported

Cycle 28 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	99
Sunitinib	40

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.039	0.2060	Not reported	Not reported	Not reported
Sunitinib	-0.007	0.1639	Not reported	Not reported	Not reported

Cycle 29 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	99
Sunitinib	38

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.019	0.2095	Not reported	Not reported	Not reported
Sunitinib	0.017	0.1601	Not reported	Not reported	Not reported

Cycle 30 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	94
Sunitinib	36

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.032	0.2244	Not reported	Not reported	Not reported
Sunitinib	-0.003	0.1557	Not reported	Not reported	Not reported

Cycle 31 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	90
Sunitinib	35

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.042	0.2246	Not reported	Not reported	Not reported
Sunitinib	-0.009	0.1508	Not reported	Not reported	Not reported

Cycle 32 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	86
Sunitinib	31

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.044	0.2095	Not reported	Not reported	Not reported
Sunitinib	0.032	0.1255	Not reported	Not reported	Not reported

Cycle 33 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	80
Sunitinib	29

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.051	0.2294	Not reported	Not reported	Not reported
Sunitinib	-0.060	0.3550	Not reported	Not reported	Not reported

Cycle 34 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	77
Sunitinib	26

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.029	0.1776	Not reported	Not reported	Not reported
Sunitinib	0.038	0.1558	Not reported	Not reported	Not reported

Cycle 35 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	66
Sunitinib	26

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.010	0.1442	Not reported	Not reported	Not reported
Sunitinib	-0.002	0.1610	Not reported	Not reported	Not reported

Cycle 36 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	65
Sunitinib	24

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.016	0.1599	Not reported	Not reported	Not reported
Sunitinib	0.030	0.1551	Not reported	Not reported	Not reported

Cycle 37 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	64
Sunitinib	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.027	0.1507	Not reported	Not reported	Not reported
Sunitinib	0.052	0.1601	Not reported	Not reported	Not reported

Cycle 38 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	59
Sunitinib	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.016	0.1459	Not reported	Not reported	Not reported
Sunitinib	0.057	0.1666	Not reported	Not reported	Not reported

Cycle 39 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	56
Sunitinib	18

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.042	0.1569	Not reported	Not reported	Not reported
Sunitinib	0.052	0.1386	Not reported	Not reported	Not reported

Cycle 40 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	55
Sunitinib	18

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.021	0.1484	Not reported	Not reported	Not reported
Sunitinib	0.060	0.1232	Not reported	Not reported	Not reported

Cycle 41 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	51
Sunitinib	17

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.030	0.1492	Not reported	Not reported	Not reported
Sunitinib	0.056	0.1853	Not reported	Not reported	Not reported

Cycle 42 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	48
Sunitinib	17

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.021	0.1634	Not reported	Not reported	Not reported
Sunitinib	0.034	0.1585	Not reported	Not reported	Not reported

Cycle 43 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	45
Sunitinib	16

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.031	0.1334	Not reported	Not reported	Not reported
Sunitinib	0.011	0.2062	Not reported	Not reported	Not reported

Cycle 44 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	48
Sunitinib	16

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.028	0.1300	Not reported	Not reported	Not reported
Sunitinib	0.016	0.2114	Not reported	Not reported	Not reported

Cycle 45 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	45
Sunitinib	15

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.050	0.1442	Not reported	Not reported	Not reported
Sunitinib	0.007	0.2191	Not reported	Not reported	Not reported

Cycle 46 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	43
Sunitinib	15

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.042	0.1380	Not reported	Not reported	Not reported
Sunitinib	-0.007	0.2495	Not reported	Not reported	Not reported

Cycle 47 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	39
Sunitinib	13

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.019	0.1240	Not reported	Not reported	Not reported
Sunitinib	-0.015	0.2335	Not reported	Not reported	Not reported

Cycle 48 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	39
Sunitinib	12

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.025	0.1566	Not reported	Not reported	Not reported
Sunitinib	0.009	0.2833	Not reported	Not reported	Not reported

Cycle 49 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	36
Sunitinib	12

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.028	0.1356	Not reported	Not reported	Not reported
Sunitinib	0.010	0.1873	Not reported	Not reported	Not reported

Cycle 50 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	34
Sunitinib	12

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.028	0.1359	Not reported	Not reported	Not reported
Sunitinib	0.028	0.2507	Not reported	Not reported	Not reported

Cycle 51 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	26
Sunitinib	11

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.011	0.1304	Not reported	Not reported	Not reported
Sunitinib	-0.010	0.2594	Not reported	Not reported	Not reported

Cycle 52 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	25
Sunitinib	11

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.036	0.1265	Not reported	Not reported	Not reported
Sunitinib	-0.035	0.2524	Not reported	Not reported	Not reported

Cycle 53 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	18
Sunitinib	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.084	0.1437	Not reported	Not reported	Not reported
Sunitinib	0.048	0.1308	Not reported	Not reported	Not reported

Cycle 54 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	18
Sunitinib	8

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.040	0.1425	Not reported	Not reported	Not reported
Sunitinib	0.078	0.1157	Not reported	Not reported	Not reported

Cycle 55 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	14
Sunitinib	5

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.046	0.1121	Not reported	Not reported	Not reported
Sunitinib	0.051	0.1060	Not reported	Not reported	Not reported

Cycle 56 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	9
Sunitinib	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.083	0.1081	Not reported	Not reported	Not reported
Sunitinib	0.025	0.1796	Not reported	Not reported	Not reported

Cycle 57 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	8
Sunitinib	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.104	0.1347	Not reported	Not reported	Not reported
Sunitinib	0.031	NA	Not reported	Not reported	Standard deviation (SD) could not be calculated as only 1 participant was analyzed.

Cycle 58 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	7
Sunitinib	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.078	0.1408	Not reported	Not reported	Not reported
Sunitinib	0.031	NA	Not reported	Not reported	SD could not be calculated as only 1 participant was analyzed.

Cycle 59 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	5
Sunitinib	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.106	0.1053	Not reported	Not reported	Not reported

Cycle 60 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	3
Sunitinib	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.040	0.1167	Not reported	Not reported	Not reported

End of Treatment

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	275
Sunitinib	297

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.111	0.2464	Not reported	Not reported	Not reported
Sunitinib	-0.069	0.2375	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.1743
value
-0.034
group Id
OG001
spread
0.1632
value
0.001
denoms
counts
group Id
OG000
value
381
group Id
OG001
value
355
units
Participants
title
Cycle 2 (Day 1)
categories
measurements
group Id
OG000
spread
0.1826
value
-0.023
group Id
OG001
spread
0.1804
value
-0.017
denoms
counts
group Id
OG000
value
356
group Id
OG001
value
317
units
Participants
title
Cycle 3 (Day 1)
categories
measurements
group Id
OG000
spread
0.1829
value
-0.029
group Id
OG001
spread
0.1667
value
-0.022
denoms
counts
group Id
OG000
value
335
group Id
OG001
value
283
units
Participants
title
Cycle 4 (Day 1)
categories
measurements
group Id
OG000
spread
0.1622
value
-0.019
group Id
OG001
spread
0.1826
value
-0.016
denoms
counts
group Id
OG000
value
324
group Id
OG001
value
260
units
Participants
title
Cycle 5 (Day 1)
categories
measurements
group Id
OG000
spread
0.1787
value
-0.025
group Id
OG001
spread
0.1967
value
-0.003
denoms
counts
group Id
OG000
value
300
group Id
OG001
value
229
units
Participants
title
Cycle 6 (Day 1)
categories
measurements
group Id
OG000
spread
0.1651
value
-0.018
group Id
OG001
spread
0.1618
value
0.008
denoms
counts
group Id
OG000
value
276
group Id
OG001
value
202
units
Participants
title
Cycle 7 (Day 1)
categories
measurements
group Id
OG000
spread
0.1848
value
-0.029
group Id
OG001
spread
0.1731
value
0.002
denoms
counts
group Id
OG000
value
264
group Id
OG001
value
177
units
Participants
title
Cycle 8 (Day 1)
categories
measurements
group Id
OG000
spread
0.2021
value
-0.029
group Id
OG001
spread
0.1662
value
-0.011
denoms
counts
group Id
OG000
value
249
group Id
OG001
value
155
units
Participants
title
Cycle 9 (Day 1)
categories
measurements
group Id
OG000
spread
0.1935
value
-0.025
group Id
OG001
spread
0.1617
value
-0.018
denoms
counts
group Id
OG000
value
236
group Id
OG001
value
152
units
Participants
title
Cycle 10 (Day 1)
categories
measurements
group Id
OG000
spread
0.1854
value
-0.020
group Id
OG001
spread
0.1642
value
0.004
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
138
units
Participants
title
Cycle 11 (Day 1)
categories
measurements
group Id
OG000
spread
0.1875
value
-0.026
group Id
OG001
spread
0.1712
value
-0.016
denoms
counts
group Id
OG000
value
209
group Id
OG001
value
123
units
Participants
title
Cycle 12 (Day 1)
categories
measurements
group Id
OG000
spread
0.1777
value
-0.026
group Id
OG001
spread
0.1549
value
-0.017
denoms
counts
group Id
OG000
value
208
group Id
OG001
value
111
units
Participants
title
Cycle 13 (Day 1)

denoms

counts
group Id
OG000
value
442
group Id
OG001
value
444
units
Participants

description

EQ-5D-5L is a 5-item participant-completed questionnaire designed to assess health status in terms of a single utility score. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. Published UK weights were used to create a single summary utility score. Utility scores range from -0.594 to 1, with higher scores representing better health status.

dispersion Type

Standard Deviation

groups

description
Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
id
OG000
title
Avelumab + Axitinib
description
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
id
OG001
title
Sunitinib

param Type

MEAN

population Description

FAS included all randomized participants. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable for the specified rows.

reporting Status

POSTED

time Frame

Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)

title

Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score

type

SECONDARY

unit Of Measure

Units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice