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NCT01668784 · OUTCOME

Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) · Source last updated 2022-08-09

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: Day 1 to 30 days post study completion (approximately 106 months)

What was measured

Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: \< 8.0 g/dL), Platelet Count (Gr 3: 25.0 -\< 50.0\*10\^9 c/L; Gr 4: \< 25.0\*10\^9 c/L), Leukocyte Count (Gr 3: 1.0 -\< 2.0\*10\^3 c/µL; Gr4: \< 1.0\*10\^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -\< 0.5\*10\^3 c/µL; Gr 4: \< 0.2\*10\^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - \< 1.0\*10\^3 c/µL; Gr 4: \< 0.5\*10\^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: \> 5.0 - 20.0 U/L \* ULN; Gr 4: \> 20.0 U/L \* ULN), AST (Gr 3: \> 5.0 - 20.0 U/L \* ULN; Gr 4: \> 20.0 U/L \* ULN), ALT (Gr 3: \> 5.0 - 20.0 U/L \* ULN; Gr 4: \> 20.0 U/L \* ULN), tBIL (Gr 3: \> 3.0 - 10.0 mg/dL \* ULN; Gr 4: \> 10.0 mg/dL \* ULN). Renal parameter=Creatinine (Grade: Gr3: \> 3.0 - 6.0 mg/dL \*ULN; Gr4: \> 6.0 mg/dL \*ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).

Analysis population: To all treated participants with evaluable measurements

Groups in this outcome

Nivolumab

Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Everolimus

Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

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
Nivolumab	406
Everolimus	397

Reported measurements

Hemoglobin, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	395
Everolimus	383

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	33	Not reported	Not reported	Not reported	Not reported
Everolimus	61	Not reported	Not reported	Not reported	Not reported

Platelet Count, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	391
Everolimus	379

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1	Not reported	Not reported	Not reported	Not reported
Everolimus	6	Not reported	Not reported	Not reported	Not reported

Platelet Count, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	391
Everolimus	379

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	0	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Leukocytes, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	394
Everolimus	380

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	0	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Leukocytes, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	394
Everolimus	380

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	391
Everolimus	377

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	28	Not reported	Not reported	Not reported	Not reported
Everolimus	43	Not reported	Not reported	Not reported	Not reported

Lymphocytes (absolute), Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	391
Everolimus	377

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	3	Not reported	Not reported	Not reported	Not reported
Everolimus	6	Not reported	Not reported	Not reported	Not reported

Absolute Neutrophil Count, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	392
Everolimus	378

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	0	Not reported	Not reported	Not reported	Not reported
Everolimus	2	Not reported	Not reported	Not reported	Not reported

Absolute Neutrophil Count, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	392
Everolimus	378

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	0	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	400
Everolimus	374

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	11	Not reported	Not reported	Not reported	Not reported
Everolimus	3	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	400
Everolimus	375

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	9	Not reported	Not reported	Not reported	Not reported
Everolimus	6	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	400
Everolimus	375

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	2	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	401
Everolimus	376

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	12	Not reported	Not reported	Not reported	Not reported
Everolimus	3	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	401
Everolimus	376

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Bilirubin Total, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	401
Everolimus	376

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	3	Not reported	Not reported	Not reported	Not reported
Everolimus	2	Not reported	Not reported	Not reported	Not reported

Creatinine, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	398
Everolimus	379

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	5	Not reported	Not reported	Not reported	Not reported
Everolimus	5	Not reported	Not reported	Not reported	Not reported

Creatinine, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	398
Everolimus	379

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	3	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Hypercalcemia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	339
Everolimus	315

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	7	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Hypercalcemia, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	339
Everolimus	315

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	4	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Hypocalcemia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	339
Everolimus	315

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	2	Not reported	Not reported	Not reported	Not reported
Everolimus	4	Not reported	Not reported	Not reported	Not reported

Hypocalcemia, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	339
Everolimus	315

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Hyperkalemia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	352
Everolimus	332

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	11	Not reported	Not reported	Not reported	Not reported
Everolimus	7	Not reported	Not reported	Not reported	Not reported

Hyperkalemia, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	352
Everolimus	332

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	3	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	352
Everolimus	332

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	5	Not reported	Not reported	Not reported	Not reported
Everolimus	3	Not reported	Not reported	Not reported	Not reported

Hypermagnesmia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	196
Everolimus	174

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	3	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesmia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	196
Everolimus	174

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1	Not reported	Not reported	Not reported	Not reported
Everolimus	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia, Grade 3

Analysis denominator · Participants

Group	Source count
Nivolumab	353
Everolimus	332

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	26	Not reported	Not reported	Not reported	Not reported
Everolimus	22	Not reported	Not reported	Not reported	Not reported

Hyponatremia, Grade 4

Analysis denominator · Participants

Group	Source count
Nivolumab	353
Everolimus	332

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1	Not reported	Not reported	Not reported	Not reported
Everolimus	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
33
group Id
OG001
value
61
denoms
counts
group Id
OG000
value
395
group Id
OG001
value
383
units
Participants
title
Hemoglobin, Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
391
group Id
OG001
value
379
units
Participants
title
Platelet Count, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
391
group Id
OG001
value
379
units
Participants
title
Platelet Count, Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
394
group Id
OG001
value
380
units
Participants
title
Leukocytes, Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
394
group Id
OG001
value
380
units
Participants
title
Leukocytes, Grade 4
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
43
denoms
counts
group Id
OG000
value
391
group Id
OG001
value
377
units
Participants
title
Lymphocytes (absolute), Grade 3
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
391
group Id
OG001
value
377
units
Participants
title
Lymphocytes (absolute), Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
392
group Id
OG001
value
378
units
Participants
title
Absolute Neutrophil Count, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
392
group Id
OG001
value
378
units
Participants
title
Absolute Neutrophil Count, Grade 4
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
400
group Id
OG001
value
374
units
Participants
title
Alkaline Phosphatase, Grade 3
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
400
group Id
OG001
value
375
units
Participants
title
Aspartate Aminotransferase, Grade 3
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
400
group Id
OG001
value
375
units
Participants
title
Aspartate Aminotransferase, Grade 4

denoms

counts
group Id
OG000
value
406
group Id
OG001
value
397
units
Participants

description

Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: \< 8.0 g/dL), Platelet Count (Gr 3: 25.0 -\< 50.0\*10\^9 c/L; Gr 4: \< 25.0\*10\^9 c/L), Leukocyte Count (Gr 3: 1.0 -\< 2.0\*10\^3 c/µL; Gr4: \< 1.0\*10\^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -\< 0.5\*10\^3 c/µL; Gr 4: \< 0.2\*10\^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - \< 1.0\*10\^3 c/µL; Gr 4: \< 0.5\*10\^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: \> 5.0 - 20.0 U/L \* ULN; Gr 4: \> 20.0 U/L \* ULN), AST (Gr 3: \> 5.0 - 20.0 U/L \* ULN; Gr 4: \> 20.0 U/L \* ULN), ALT (Gr 3: \> 5.0 - 20.0 U/L \* ULN; Gr 4: \> 20.0 U/L \* ULN), tBIL (Gr 3: \> 3.0 - 10.0 mg/dL \* ULN; Gr 4: \> 10.0 mg/dL \* ULN). Renal parameter=Creatinine (Grade: Gr3: \> 3.0 - 6.0 mg/dL \*ULN; Gr4: \> 6.0 mg/dL \*ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).

groups

description
Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
id
OG000
title
Nivolumab
description
Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
id
OG001
title
Everolimus

param Type

COUNT_OF_PARTICIPANTS

population Description

To all treated participants with evaluable measurements

reporting Status

POSTED

time Frame

Day 1 to 30 days post study completion (approximately 106 months)

title

Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice