Number of Participants With Laboratory Values Grade Shifting From Baseline
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma · Source last updated 2026-08-24
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 first dose to 30 days following last dose (Up to 30 Months)
What was measured
Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
Analysis population: All Treated Participants
Groups in this outcome
Treatment A
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
Treatment B
Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses)
Then
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
Treatment C
Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
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
Treatment A
320
Treatment B
50
Treatment C
320
Reported measurements
Hemoglobin: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
251
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
117
Not reported
Not reported
Not reported
Not reported
Treatment B
23
Not reported
Not reported
Not reported
Not reported
Treatment C
190
Not reported
Not reported
Not reported
Not reported
Hemoglobin: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
251
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
8
Not reported
Not reported
Not reported
Not reported
Treatment B
5
Not reported
Not reported
Not reported
Not reported
Treatment C
15
Not reported
Not reported
Not reported
Not reported
Platelet Count: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
48
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
129
Not reported
Not reported
Not reported
Not reported
Treatment B
24
Not reported
Not reported
Not reported
Not reported
Treatment C
216
Not reported
Not reported
Not reported
Not reported
Platelet Count: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
48
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
2
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
30
Not reported
Not reported
Not reported
Not reported
Leukocytes: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
311
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
116
Not reported
Not reported
Not reported
Not reported
Treatment B
26
Not reported
Not reported
Not reported
Not reported
Treatment C
206
Not reported
Not reported
Not reported
Not reported
Leukocytes: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
311
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
1
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
16
Not reported
Not reported
Not reported
Not reported
Lymphocytes: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
228
Treatment B
36
Treatment C
225
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
95
Not reported
Not reported
Not reported
Not reported
Treatment B
20
Not reported
Not reported
Not reported
Not reported
Treatment C
102
Not reported
Not reported
Not reported
Not reported
Lymphocytes: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
228
Treatment B
36
Treatment C
225
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
15
Not reported
Not reported
Not reported
Not reported
Treatment B
4
Not reported
Not reported
Not reported
Not reported
Treatment C
23
Not reported
Not reported
Not reported
Not reported
Neutrophil: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
311
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
112
Not reported
Not reported
Not reported
Not reported
Treatment B
22
Not reported
Not reported
Not reported
Not reported
Treatment C
209
Not reported
Not reported
Not reported
Not reported
Neutrophil: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
311
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
10
Not reported
Not reported
Not reported
Not reported
Treatment B
2
Not reported
Not reported
Not reported
Not reported
Treatment C
36
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
131
Not reported
Not reported
Not reported
Not reported
Treatment B
31
Not reported
Not reported
Not reported
Not reported
Treatment C
115
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
9
Not reported
Not reported
Not reported
Not reported
Treatment B
6
Not reported
Not reported
Not reported
Not reported
Treatment C
5
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase (AST): Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
245
Not reported
Not reported
Not reported
Not reported
Treatment B
42
Not reported
Not reported
Not reported
Not reported
Treatment C
177
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase (AST): Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
25
Not reported
Not reported
Not reported
Not reported
Treatment B
19
Not reported
Not reported
Not reported
Not reported
Treatment C
8
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase (ALT): Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
249
Not reported
Not reported
Not reported
Not reported
Treatment B
43
Not reported
Not reported
Not reported
Not reported
Treatment C
121
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase (ALT) Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
31
Not reported
Not reported
Not reported
Not reported
Treatment B
24
Not reported
Not reported
Not reported
Not reported
Treatment C
11
Not reported
Not reported
Not reported
Not reported
Bilirubin: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
55
Not reported
Not reported
Not reported
Not reported
Treatment B
17
Not reported
Not reported
Not reported
Not reported
Treatment C
68
Not reported
Not reported
Not reported
Not reported
Bilirubin: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
316
Treatment B
49
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
3
Not reported
Not reported
Not reported
Not reported
Treatment B
3
Not reported
Not reported
Not reported
Not reported
Treatment C
3
Not reported
Not reported
Not reported
Not reported
Creatinine: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
311
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
123
Not reported
Not reported
Not reported
Not reported
Treatment B
22
Not reported
Not reported
Not reported
Not reported
Treatment C
132
Not reported
Not reported
Not reported
Not reported
Creatinine: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
311
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
4
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
2
Not reported
Not reported
Not reported
Not reported
Amylase: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
285
Treatment B
46
Treatment C
277
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
117
Not reported
Not reported
Not reported
Not reported
Treatment B
26
Not reported
Not reported
Not reported
Not reported
Treatment C
77
Not reported
Not reported
Not reported
Not reported
Amylase: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
285
Treatment B
46
Treatment C
277
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
28
Not reported
Not reported
Not reported
Not reported
Treatment B
10
Not reported
Not reported
Not reported
Not reported
Treatment C
16
Not reported
Not reported
Not reported
Not reported
Lipase: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
308
Treatment B
47
Treatment C
300
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
127
Not reported
Not reported
Not reported
Not reported
Treatment B
27
Not reported
Not reported
Not reported
Not reported
Treatment C
114
Not reported
Not reported
Not reported
Not reported
Lipase: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
308
Treatment B
47
Treatment C
300
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
42
Not reported
Not reported
Not reported
Not reported
Treatment B
20
Not reported
Not reported
Not reported
Not reported
Treatment C
40
Not reported
Not reported
Not reported
Not reported
Hypernatremia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
33
Not reported
Not reported
Not reported
Not reported
Treatment B
7
Not reported
Not reported
Not reported
Not reported
Treatment C
24
Not reported
Not reported
Not reported
Not reported
Hypernatremia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
0
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
0
Not reported
Not reported
Not reported
Not reported
Hyponatremia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
136
Not reported
Not reported
Not reported
Not reported
Treatment B
30
Not reported
Not reported
Not reported
Not reported
Treatment C
111
Not reported
Not reported
Not reported
Not reported
Hyponatremia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
310
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
34
Not reported
Not reported
Not reported
Not reported
Treatment B
8
Not reported
Not reported
Not reported
Not reported
Treatment C
37
Not reported
Not reported
Not reported
Not reported
Hyperkalemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
111
Not reported
Not reported
Not reported
Not reported
Treatment B
25
Not reported
Not reported
Not reported
Not reported
Treatment C
82
Not reported
Not reported
Not reported
Not reported
Hyperkalemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
15
Not reported
Not reported
Not reported
Not reported
Treatment B
2
Not reported
Not reported
Not reported
Not reported
Treatment C
3
Not reported
Not reported
Not reported
Not reported
Hypokalemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
61
Not reported
Not reported
Not reported
Not reported
Treatment B
8
Not reported
Not reported
Not reported
Not reported
Treatment C
35
Not reported
Not reported
Not reported
Not reported
Hypokalemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
317
Treatment B
49
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
10
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
5
Not reported
Not reported
Not reported
Not reported
Hypercalcemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
314
Treatment B
48
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
30
Not reported
Not reported
Not reported
Not reported
Treatment B
7
Not reported
Not reported
Not reported
Not reported
Treatment C
46
Not reported
Not reported
Not reported
Not reported
Hypercalcemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
314
Treatment B
48
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
1
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
3
Not reported
Not reported
Not reported
Not reported
Hypocalcemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
314
Treatment B
48
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
170
Not reported
Not reported
Not reported
Not reported
Treatment B
25
Not reported
Not reported
Not reported
Not reported
Treatment C
73
Not reported
Not reported
Not reported
Not reported
Hypocalcemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
314
Treatment B
48
Treatment C
309
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
6
Not reported
Not reported
Not reported
Not reported
Treatment B
2
Not reported
Not reported
Not reported
Not reported
Treatment C
2
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
308
Treatment B
49
Treatment C
304
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
38
Not reported
Not reported
Not reported
Not reported
Treatment B
9
Not reported
Not reported
Not reported
Not reported
Treatment C
26
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
308
Treatment B
49
Treatment C
304
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
12
Not reported
Not reported
Not reported
Not reported
Treatment B
4
Not reported
Not reported
Not reported
Not reported
Treatment C
7
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
308
Treatment B
49
Treatment C
304
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
146
Not reported
Not reported
Not reported
Not reported
Treatment B
16
Not reported
Not reported
Not reported
Not reported
Treatment C
77
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
308
Treatment B
49
Treatment C
304
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
4
Not reported
Not reported
Not reported
Not reported
Treatment B
1
Not reported
Not reported
Not reported
Not reported
Treatment C
1
Not reported
Not reported
Not reported
Not reported
Hyperphosphatemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
307
Treatment B
49
Treatment C
307
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
0
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
0
Not reported
Not reported
Not reported
Not reported
Hyperphosphatemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
307
Treatment B
49
Treatment C
307
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
0
Not reported
Not reported
Not reported
Not reported
Treatment B
0
Not reported
Not reported
Not reported
Not reported
Treatment C
0
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
307
Treatment B
49
Treatment C
307
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
211
Not reported
Not reported
Not reported
Not reported
Treatment B
33
Not reported
Not reported
Not reported
Not reported
Treatment C
147
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
307
Treatment B
49
Treatment C
307
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
85
Not reported
Not reported
Not reported
Not reported
Treatment B
12
Not reported
Not reported
Not reported
Not reported
Treatment C
31
Not reported
Not reported
Not reported
Not reported
Hyperglycemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
170
Treatment B
33
Treatment C
173
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
74
Not reported
Not reported
Not reported
Not reported
Treatment B
17
Not reported
Not reported
Not reported
Not reported
Treatment C
76
Not reported
Not reported
Not reported
Not reported
Hyperglycemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
170
Treatment B
33
Treatment C
173
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
6
Not reported
Not reported
Not reported
Not reported
Treatment B
2
Not reported
Not reported
Not reported
Not reported
Treatment C
3
Not reported
Not reported
Not reported
Not reported
Hypoglycemia: Any grade
Analysis denominator · Participants
Group
Source count
Treatment A
262
Treatment B
45
Treatment C
270
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
67
Not reported
Not reported
Not reported
Not reported
Treatment B
9
Not reported
Not reported
Not reported
Not reported
Treatment C
37
Not reported
Not reported
Not reported
Not reported
Hypoglycemia: Grade 3-4
Analysis denominator · Participants
Group
Source count
Treatment A
262
Treatment B
45
Treatment C
270
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment A
2
Not reported
Not reported
Not reported
Not reported
Treatment B
1
Not reported
Not reported
Not reported
Not reported
Treatment C
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
117
group Id
OG001
value
23
group Id
OG002
value
190
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
49
group Id
OG002
value
251
units
Participants
title
Hemoglobin: Any grade
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
5
group Id
OG002
value
15
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
49
group Id
OG002
value
251
units
Participants
title
Hemoglobin: Grade 3-4
categories
measurements
group Id
OG000
value
129
group Id
OG001
value
24
group Id
OG002
value
216
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
48
group Id
OG002
value
310
units
Participants
title
Platelet Count: Any grade
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
30
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
48
group Id
OG002
value
310
units
Participants
title
Platelet Count: Grade 3-4
categories
measurements
group Id
OG000
value
116
group Id
OG001
value
26
group Id
OG002
value
206
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
49
group Id
OG002
value
311
units
Participants
title
Leukocytes: Any grade
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
16
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
49
group Id
OG002
value
311
units
Participants
title
Leukocytes: Grade 3-4
categories
measurements
group Id
OG000
value
95
group Id
OG001
value
20
group Id
OG002
value
102
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
36
group Id
OG002
value
225
units
Participants
title
Lymphocytes: Any grade
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
4
group Id
OG002
value
23
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
36
group Id
OG002
value
225
units
Participants
title
Lymphocytes: Grade 3-4
categories
measurements
group Id
OG000
value
112
group Id
OG001
value
22
group Id
OG002
value
209
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
49
group Id
OG002
value
311
units
Participants
title
Neutrophil: Any grade
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
2
group Id
OG002
value
36
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
49
group Id
OG002
value
311
units
Participants
title
Neutrophil: Grade 3-4
categories
measurements
group Id
OG000
value
131
group Id
OG001
value
31
group Id
OG002
value
115
denoms
counts
group Id
OG000
value
317
group Id
OG001
value
49
group Id
OG002
value
310
units
Participants
title
Alkaline Phosphatase: Any grade
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
6
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
317
group Id
OG001
value
49
group Id
OG002
value
310
units
Participants
title
Alkaline Phosphatase: Grade 3-4
denoms
counts
group Id
OG000
value
320
group Id
OG001
value
50
group Id
OG002
value
320
units
Participants
description
Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
groups
description
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
id
OG000
title
Treatment A
description
Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses)
Then
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
id
OG001
title
Treatment B
description
Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
id
OG002
title
Treatment C
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Participants
reporting Status
POSTED
time Frame
From first dose to 30 days following last dose (Up to 30 Months)
title
Number of Participants With Laboratory Values Grade Shifting From Baseline