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NCT02684006 · OUTCOME

Change From Baseline in EQ-5D Visual Analogue Scale (VAS) 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-VAS records the participant's self-rated health status from 0 (worst imaginable health status) to 100 (best imaginable health status), where higher scores indicated 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	347

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.9	16.12	Not reported	Not reported	Not reported
Sunitinib	-0.2	15.85	Not reported	Not reported	Not reported

Cycle 3 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	355
Sunitinib	312

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.4	16.39	Not reported	Not reported	Not reported
Sunitinib	0.4	16.44	Not reported	Not reported	Not reported

Cycle 4 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	333
Sunitinib	278

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-0.1	17.23	Not reported	Not reported	Not reported
Sunitinib	0.7	17.26	Not reported	Not reported	Not reported

Cycle 5 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	322
Sunitinib	258

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0.4	16.66	Not reported	Not reported	Not reported
Sunitinib	1.8	16.16	Not reported	Not reported	Not reported

Cycle 6 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	296
Sunitinib	224

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1.3	16.05	Not reported	Not reported	Not reported
Sunitinib	2.6	15.35	Not reported	Not reported	Not reported

Cycle 7 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	275
Sunitinib	197

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1.2	16.34	Not reported	Not reported	Not reported
Sunitinib	3.3	14.91	Not reported	Not reported	Not reported

Cycle 8 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	266
Sunitinib	174

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1.4	16.54	Not reported	Not reported	Not reported
Sunitinib	2.9	13.84	Not reported	Not reported	Not reported

Cycle 9 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	246
Sunitinib	154

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2.0	16.06	Not reported	Not reported	Not reported
Sunitinib	3.3	13.77	Not reported	Not reported	Not reported

Cycle 10 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	233
Sunitinib	150

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1.6	15.12	Not reported	Not reported	Not reported
Sunitinib	2.4	14.46	Not reported	Not reported	Not reported

Cycle 11 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	225
Sunitinib	135

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2.5	15.70	Not reported	Not reported	Not reported
Sunitinib	4.1	12.91	Not reported	Not reported	Not reported

Cycle 12 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	207
Sunitinib	121

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2.1	14.72	Not reported	Not reported	Not reported
Sunitinib	2.6	14.59	Not reported	Not reported	Not reported

Cycle 13 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	205
Sunitinib	110

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.0	14.39	Not reported	Not reported	Not reported
Sunitinib	2.7	14.29	Not reported	Not reported	Not reported

Cycle 14 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	196
Sunitinib	101

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2.7	15.07	Not reported	Not reported	Not reported
Sunitinib	3.0	13.98	Not reported	Not reported	Not reported

Cycle 15 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	192
Sunitinib	101

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.1	14.97	Not reported	Not reported	Not reported
Sunitinib	4.7	13.63	Not reported	Not reported	Not reported

Cycle 16 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	175
Sunitinib	94

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2.9	15.08	Not reported	Not reported	Not reported
Sunitinib	3.6	14.02	Not reported	Not reported	Not reported

Cycle 17 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	167
Sunitinib	88

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.0	15.44	Not reported	Not reported	Not reported
Sunitinib	3.2	12.88	Not reported	Not reported	Not reported

Cycle 18 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	162
Sunitinib	82

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.2	15.31	Not reported	Not reported	Not reported
Sunitinib	2.0	13.69	Not reported	Not reported	Not reported

Cycle 19 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	147
Sunitinib	78

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.5	15.61	Not reported	Not reported	Not reported
Sunitinib	3.0	13.10	Not reported	Not reported	Not reported

Cycle 20 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	142
Sunitinib	71

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.9	15.15	Not reported	Not reported	Not reported
Sunitinib	3.1	12.58	Not reported	Not reported	Not reported

Cycle 21 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	132
Sunitinib	67

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.7	16.30	Not reported	Not reported	Not reported
Sunitinib	2.1	13.00	Not reported	Not reported	Not reported

Cycle 22 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	128
Sunitinib	60

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.3	16.43	Not reported	Not reported	Not reported
Sunitinib	2.6	12.82	Not reported	Not reported	Not reported

Cycle 23 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	117
Sunitinib	58

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.7	16.90	Not reported	Not reported	Not reported
Sunitinib	1.3	15.16	Not reported	Not reported	Not reported

Cycle 24 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	115
Sunitinib	55

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3.3	18.70	Not reported	Not reported	Not reported
Sunitinib	4.5	13.45	Not reported	Not reported	Not reported

Cycle 25 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	113
Sunitinib	54

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.6	15.28	Not reported	Not reported	Not reported
Sunitinib	4.2	14.42	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	4.4	17.10	Not reported	Not reported	Not reported
Sunitinib	3.4	13.00	Not reported	Not reported	Not reported

Cycle 27 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	106
Sunitinib	45

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.7	16.59	Not reported	Not reported	Not reported
Sunitinib	5.4	13.43	Not reported	Not reported	Not reported

Cycle 28 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	98
Sunitinib	40

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.3	16.08	Not reported	Not reported	Not reported
Sunitinib	5.0	13.84	Not reported	Not reported	Not reported

Cycle 29 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	98
Sunitinib	38

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.8	15.44	Not reported	Not reported	Not reported
Sunitinib	5.4	14.24	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	6.0	15.78	Not reported	Not reported	Not reported
Sunitinib	5.3	14.61	Not reported	Not reported	Not reported

Cycle 31 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	89
Sunitinib	35

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.7	15.42	Not reported	Not reported	Not reported
Sunitinib	5.2	14.88	Not reported	Not reported	Not reported

Cycle 32 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	85
Sunitinib	31

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.4	16.35	Not reported	Not reported	Not reported
Sunitinib	6.0	13.57	Not reported	Not reported	Not reported

Cycle 33 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	79
Sunitinib	29

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.5	16.07	Not reported	Not reported	Not reported
Sunitinib	3.6	20.61	Not reported	Not reported	Not reported

Cycle 34 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	76
Sunitinib	26

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.8	15.25	Not reported	Not reported	Not reported
Sunitinib	6.1	15.91	Not reported	Not reported	Not reported

Cycle 35 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	65
Sunitinib	26

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.0	14.53	Not reported	Not reported	Not reported
Sunitinib	6.4	15.61	Not reported	Not reported	Not reported

Cycle 36 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	64
Sunitinib	24

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.0	15.63	Not reported	Not reported	Not reported
Sunitinib	5.2	17.11	Not reported	Not reported	Not reported

Cycle 37 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	63
Sunitinib	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.8	14.63	Not reported	Not reported	Not reported
Sunitinib	4.5	15.86	Not reported	Not reported	Not reported

Cycle 38 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	58
Sunitinib	20

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.3	14.58	Not reported	Not reported	Not reported
Sunitinib	4.3	17.58	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	5.3	14.04	Not reported	Not reported	Not reported
Sunitinib	5.9	15.75	Not reported	Not reported	Not reported

Cycle 40 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	54
Sunitinib	18

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.0	15.00	Not reported	Not reported	Not reported
Sunitinib	4.7	18.17	Not reported	Not reported	Not reported

Cycle 41 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	52
Sunitinib	17

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.6	13.69	Not reported	Not reported	Not reported
Sunitinib	6.2	18.37	Not reported	Not reported	Not reported

Cycle 42 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	47
Sunitinib	17

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.3	13.68	Not reported	Not reported	Not reported
Sunitinib	5.4	18.19	Not reported	Not reported	Not reported

Cycle 43 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	44
Sunitinib	16

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.6	11.64	Not reported	Not reported	Not reported
Sunitinib	5.4	20.14	Not reported	Not reported	Not reported

Cycle 44 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	47
Sunitinib	16

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.9	13.38	Not reported	Not reported	Not reported
Sunitinib	5.1	19.77	Not reported	Not reported	Not reported

Cycle 45 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	44
Sunitinib	15

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.3	12.55	Not reported	Not reported	Not reported
Sunitinib	1.5	17.97	Not reported	Not reported	Not reported

Cycle 46 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	41
Sunitinib	15

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6.7	13.25	Not reported	Not reported	Not reported
Sunitinib	0.3	19.31	Not reported	Not reported	Not reported

Cycle 47 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	38
Sunitinib	13

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.4	11.10	Not reported	Not reported	Not reported
Sunitinib	2.5	18.07	Not reported	Not reported	Not reported

Cycle 48 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	38
Sunitinib	12

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.4	11.73	Not reported	Not reported	Not reported
Sunitinib	3.5	21.77	Not reported	Not reported	Not reported

Cycle 49 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	35
Sunitinib	12

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.2	12.21	Not reported	Not reported	Not reported
Sunitinib	1.9	21.42	Not reported	Not reported	Not reported

Cycle 50 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	33
Sunitinib	12

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4.8	13.07	Not reported	Not reported	Not reported
Sunitinib	2.9	20.53	Not reported	Not reported	Not reported

Cycle 51 (Day 1)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	26
Sunitinib	10

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5.8	12.36	Not reported	Not reported	Not reported
Sunitinib	2.1	22.93	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	4.2	11.37	Not reported	Not reported	Not reported
Sunitinib	1.5	19.94	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	3.2	11.43	Not reported	Not reported	Not reported
Sunitinib	7.7	16.22	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	4.6	11.54	Not reported	Not reported	Not reported
Sunitinib	7.5	13.34	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	4.6	11.65	Not reported	Not reported	Not reported
Sunitinib	7.8	17.89	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	-0.6	8.08	Not reported	Not reported	Not reported
Sunitinib	-6.0	5.66	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	-1.9	10.67	Not reported	Not reported	Not reported
Sunitinib	-2.0	NA	Not reported	Not reported	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	-2.1	8.59	Not reported	Not reported	Not reported
Sunitinib	-2.0	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	0.0	9.35	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	-1.7	16.07	Not reported	Not reported	Not reported

End of treatment

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	277
Sunitinib	296

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	-5.0	19.92	Not reported	Not reported	Not reported
Sunitinib	-4.3	19.63	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16.12
value
-0.9
group Id
OG001
spread
15.85
value
-0.2
denoms
counts
group Id
OG000
value
381
group Id
OG001
value
347
units
Participants
title
Cycle 2 (Day 1)
categories
measurements
group Id
OG000
spread
16.39
value
-0.4
group Id
OG001
spread
16.44
value
0.4
denoms
counts
group Id
OG000
value
355
group Id
OG001
value
312
units
Participants
title
Cycle 3 (Day 1)
categories
measurements
group Id
OG000
spread
17.23
value
-0.1
group Id
OG001
spread
17.26
value
0.7
denoms
counts
group Id
OG000
value
333
group Id
OG001
value
278
units
Participants
title
Cycle 4 (Day 1)
categories
measurements
group Id
OG000
spread
16.66
value
0.4
group Id
OG001
spread
16.16
value
1.8
denoms
counts
group Id
OG000
value
322
group Id
OG001
value
258
units
Participants
title
Cycle 5 (Day 1)
categories
measurements
group Id
OG000
spread
16.05
value
1.3
group Id
OG001
spread
15.35
value
2.6
denoms
counts
group Id
OG000
value
296
group Id
OG001
value
224
units
Participants
title
Cycle 6 (Day 1)
categories
measurements
group Id
OG000
spread
16.34
value
1.2
group Id
OG001
spread
14.91
value
3.3
denoms
counts
group Id
OG000
value
275
group Id
OG001
value
197
units
Participants
title
Cycle 7 (Day 1)
categories
measurements
group Id
OG000
spread
16.54
value
1.4
group Id
OG001
spread
13.84
value
2.9
denoms
counts
group Id
OG000
value
266
group Id
OG001
value
174
units
Participants
title
Cycle 8 (Day 1)
categories
measurements
group Id
OG000
spread
16.06
value
2.0
group Id
OG001
spread
13.77
value
3.3
denoms
counts
group Id
OG000
value
246
group Id
OG001
value
154
units
Participants
title
Cycle 9 (Day 1)
categories
measurements
group Id
OG000
spread
15.12
value
1.6
group Id
OG001
spread
14.46
value
2.4
denoms
counts
group Id
OG000
value
233
group Id
OG001
value
150
units
Participants
title
Cycle 10 (Day 1)
categories
measurements
group Id
OG000
spread
15.70
value
2.5
group Id
OG001
spread
12.91
value
4.1
denoms
counts
group Id
OG000
value
225
group Id
OG001
value
135
units
Participants
title
Cycle 11 (Day 1)
categories
measurements
group Id
OG000
spread
14.72
value
2.1
group Id
OG001
spread
14.59
value
2.6
denoms
counts
group Id
OG000
value
207
group Id
OG001
value
121
units
Participants
title
Cycle 12 (Day 1)
categories
measurements
group Id
OG000
spread
14.39
value
3.0
group Id
OG001
spread
14.29
value
2.7
denoms
counts
group Id
OG000
value
205
group Id
OG001
value
110
units
Participants
title
Cycle 13 (Day 1)

denoms

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

description

EQ-VAS records the participant's self-rated health status from 0 (worst imaginable health status) to 100 (best imaginable health status), where higher scores indicated 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 EQ-5D Visual Analogue Scale (VAS) Score

type

SECONDARY

unit Of Measure

Units on a scale

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Preserved source evidence · Not medical advice