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NCT02684006 · OUTCOME

Number of Participants According to Grade Shift in Chemistry Parameters

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

What was measured

Following chemistry parameters were assessed: alanine aminotransferase(ALT) increased, alkaline phosphatase(ALP) increased, aspartate aminotransferase(AST) increased, blood bilirubin increased, cholesterol high, creatinine phosphokinase(CPK) increased, creatinine increased, gamma glutamyl transferase(GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesmia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased and serum amylase increased. Laboratory abnormality graded as per NCI CTCAE v4.03; G0=non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported. Only non-zero categories for any reporting arm are reported.

Analysis population: Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "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	428
Sunitinib	433

Reported measurements

ALT increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	42	Not reported	Not reported	Not reported	Not reported
Sunitinib	19	Not reported	Not reported	Not reported	Not reported

ALT increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

ALP increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	9	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

ALP increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5	Not reported	Not reported	Not reported	Not reported
Sunitinib	6	Not reported	Not reported	Not reported	Not reported

ALP increased (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

ALP increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

AST increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	26	Not reported	Not reported	Not reported	Not reported
Sunitinib	16	Not reported	Not reported	Not reported	Not reported

AST increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

AST increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3	Not reported	Not reported	Not reported	Not reported
Sunitinib	6	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Cholesterol high (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	413

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	8	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Cholesterol high (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	413

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Cholesterol high (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	413

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

CPK increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	417
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	7	Not reported	Not reported	Not reported	Not reported
Sunitinib	7	Not reported	Not reported	Not reported	Not reported

CPK increased (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	417
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

CPK increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	417
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

CPK increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	417
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Creatinine increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	7	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Creatinine increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	5	Not reported	Not reported	Not reported	Not reported

Creatinine increased (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Creatinine increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

GGT increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	15	Not reported	Not reported	Not reported	Not reported
Sunitinib	16	Not reported	Not reported	Not reported	Not reported

GGT increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	20	Not reported	Not reported	Not reported	Not reported
Sunitinib	7	Not reported	Not reported	Not reported	Not reported

GGT increased (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	12	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

GGT increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	7	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

GGT increased (Baseline G4 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	415

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypercalcemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

Hypercalcemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Hypercalcemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypercalcemia (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Hypercalcemia (Baseline G4 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	37	Not reported	Not reported	Not reported	Not reported
Sunitinib	20	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	5	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Hyperglycemia (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	6	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

Hyperkalemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	19	Not reported	Not reported	Not reported	Not reported
Sunitinib	16	Not reported	Not reported	Not reported	Not reported

Hyperkalemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	5	Not reported	Not reported	Not reported	Not reported

Hyperkalemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Hyperkalemia (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Hyperkalemia (Baseline G4 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	13	Not reported	Not reported	Not reported	Not reported
Sunitinib	20	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Hypernatremia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	7	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	411

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	18	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	411

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	31	Not reported	Not reported	Not reported	Not reported
Sunitinib	23	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	411

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	15	Not reported	Not reported	Not reported	Not reported
Sunitinib	6	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	411

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	5	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia (Baseline G4 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	411

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypoalbunemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3	Not reported	Not reported	Not reported	Not reported
Sunitinib	6	Not reported	Not reported	Not reported	Not reported

Hypoalbunemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypoalbunemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Hypoalbunemia (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Hypocalcemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

Hypocalcemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	0	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypocalcemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	418
Sunitinib	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Hypoglycemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypokalemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	17	Not reported	Not reported	Not reported	Not reported
Sunitinib	15	Not reported	Not reported	Not reported	Not reported

Hypokalemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	3	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2	Not reported	Not reported	Not reported	Not reported
Sunitinib	1	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	42	Not reported	Not reported	Not reported	Not reported
Sunitinib	35	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	19	Not reported	Not reported	Not reported	Not reported
Sunitinib	14	Not reported	Not reported	Not reported	Not reported

Hyponatremia (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	428
Sunitinib	433

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	2	Not reported	Not reported	Not reported	Not reported

Lipase increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	414

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	63	Not reported	Not reported	Not reported	Not reported
Sunitinib	27	Not reported	Not reported	Not reported	Not reported

Lipase increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	414

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	19	Not reported	Not reported	Not reported	Not reported
Sunitinib	8	Not reported	Not reported	Not reported	Not reported

Lipase increased (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	414

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	7	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Lipase increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	414

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	2	Not reported	Not reported	Not reported	Not reported
Sunitinib	7	Not reported	Not reported	Not reported	Not reported

Lipase increased (Baseline G4 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	419
Sunitinib	414

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	0	Not reported	Not reported	Not reported	Not reported

Serum amylase increased (Baseline G0 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	412
Sunitinib	407

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	21	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

Serum amylase increased (Baseline G1 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	412
Sunitinib	407

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	12	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

Serum amylase increased (Baseline G2 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	412
Sunitinib	407

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	4	Not reported	Not reported	Not reported	Not reported
Sunitinib	4	Not reported	Not reported	Not reported	Not reported

Serum amylase increased (Baseline G3 to post-baseline G3-4)

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	412
Sunitinib	407

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	1	Not reported	Not reported	Not reported	Not reported
Sunitinib	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
42
group Id
OG001
value
19
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
ALT increased (Baseline G0 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
ALT increased (Baseline G1 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
ALP increased (Baseline G0 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
ALP increased (Baseline G1 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
ALP increased (Baseline G2 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
ALP increased (Baseline G3 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
16
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
AST increased (Baseline G0 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
AST increased (Baseline G1 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
AST increased (Baseline G3 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
Blood bilirubin increased (Baseline G0 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants
title
Blood bilirubin increased (Baseline G1 to post-baseline G3-4)
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
419
group Id
OG001
value
413
units
Participants
title
Cholesterol high (Baseline G0 to post-baseline G3-4)

denoms

counts
group Id
OG000
value
428
group Id
OG001
value
433
units
Participants

description

Following chemistry parameters were assessed: alanine aminotransferase(ALT) increased, alkaline phosphatase(ALP) increased, aspartate aminotransferase(AST) increased, blood bilirubin increased, cholesterol high, creatinine phosphokinase(CPK) increased, creatinine increased, gamma glutamyl transferase(GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesmia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased and serum amylase increased. Laboratory abnormality graded as per NCI CTCAE v4.03; G0=non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported. Only non-zero categories for any reporting arm are reported.

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

COUNT_OF_PARTICIPANTS

population Description

Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows.

reporting Status

POSTED

time Frame

From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

title

Number of Participants According to Grade Shift in Chemistry Parameters

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice