NCT01908426 · BASELINE

Baseline characteristics

Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib · Source last updated 2021-05-06

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

denoms

counts
group Id
BG000
value
470
group Id
BG001
value
237
group Id
BG002
value
707
units
Participants

groups

description
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
id
BG000
title
Cabozantinib (XL184)
description
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
22
upper Limit
86
value
64.0
group Id
BG001
lower Limit
24
upper Limit
86
value
64.0
group Id
BG002
lower Limit
22
upper Limit
86
value
64.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
240
group Id
BG001
value
124
group Id
BG002
value
364
title
< 65 years old
measurements
group Id
BG000
value
158
group Id
BG001
value
75
group Id
BG002
value
233
title
65 to < 75 years old
measurements
group Id
BG000
value
67
group Id
BG001
value
35
group Id
BG002
value
102
title
75 to < 85 years old
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
≥ 85 years old
title
Age, Customized
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
91
group Id
BG001
value
35
group Id
BG002
value
126
title
Female
measurements
group Id
BG000
value
379
group Id
BG001
value
202
group Id
BG002
value
581
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
12
group Id
BG002
value
30
title
Hispanic or Latino
measurements
group Id
BG000
value
417
group Id
BG001
value
215
group Id
BG002
value
632
title
Not Hispanic or Latino
measurements
group Id
BG000
value
35
group Id
BG001
value
10
group Id
BG002
value
45
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
159
group Id
BG001
value
82
group Id
BG002
value
241
title
Asian
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
8
group Id
BG001
value
11
group Id
BG002
value
19
title
Black or African American
measurements
group Id
BG000
value
264
group Id
BG001
value
130
group Id
BG002
value
394
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
36
group Id
BG001
value
13
group Id
BG002
value
49
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
11
group Id
BG002
value
26
title
Australia / New Zealand
categories
measurements
group Id
BG000
value
116
group Id
BG001
value
59
group Id
BG002
value
175
title
Asia
categories
measurements
group Id
BG000
value
231
group Id
BG001
value
108
group Id
BG002
value
339
title
Europe
categories
measurements
group Id
BG000
value
108
group Id
BG001
value
59
group Id
BG002
value
167
title
North America (USA / Canada)
param Type
COUNT_OF_PARTICIPANTS
title
Geographic Region
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
368
group Id
BG001
value
186
group Id
BG002
value
554
title
Yes
measurements
group Id
BG000
value
102
group Id
BG001
value
51
group Id
BG002
value
153
title
No
description
Interactive voice/web response system (IxRS)
param Type
COUNT_OF_PARTICIPANTS
title
Presence of extrahepatic spread of disease and/or macrovascular invasion (stratification per IxRS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
182
group Id
BG001
value
90
group Id
BG002
value
272
title
HBV (with or without known HCV)
measurements
group Id
BG000
value
100
group Id
BG001
value
51
group Id
BG002
value
151
title
HCV (without known HBV)
measurements
group Id
BG000
value
188
group Id
BG001
value
96
group Id
BG002
value
284
title
Other (neither HBV nor HCV)
param Type
COUNT_OF_PARTICIPANTS
title
Etiology of disease (stratification factor per IxRS),
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
116
group Id
BG001
value
59
group Id
BG002
value
175
title
Asia
measurements
group Id
BG000
value
354
group Id
BG001
value
178
group Id
BG002
value
532
title
Other Regions
param Type
COUNT_OF_PARTICIPANTS
title
Geographic region (stratification factor per IxRS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
245
group Id
BG001
value
131
group Id
BG002
value
376
title
0
measurements
group Id
BG000
value
224
group Id
BG001
value
106
group Id
BG002
value
330
title
1
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
2
description
The ECOG performance scale is: 0 = Normal activity. Fully active, able to carry on all predisease performance without restriction, 1 = Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work), 2 = In bed \< 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
78
group Id
BG001
value
42
group Id
BG002
value
120
title
Current
measurements
group Id
BG000
value
229
group Id
BG001
value
122
group Id
BG002
value
351
title
Former
measurements
group Id
BG000
value
160
group Id
BG001
value
71
group Id
BG002
value
231
title
Never
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Smoking history
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
65
group Id
BG001
value
30
group Id
BG002
value
95
title
Current
measurements
group Id
BG000
value
223
group Id
BG001
value
124
group Id
BG002
value
347
title
Former
measurements
group Id
BG000
value
176
group Id
BG001
value
81
group Id
BG002
value
257
title
Never
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Alcohol use
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
470
group Id
BG001
value
237
group Id
BG002
value
707
units
Participants

groups

description
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
id
BG000
title
Cabozantinib (XL184)
description
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
22
upper Limit
86
value
64.0
group Id
BG001
lower Limit
24
upper Limit
86
value
64.0
group Id
BG002
lower Limit
22
upper Limit
86
value
64.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
240
group Id
BG001
value
124
group Id
BG002
value
364
title
< 65 years old
measurements
group Id
BG000
value
158
group Id
BG001
value
75
group Id
BG002
value
233
title
65 to < 75 years old
measurements
group Id
BG000
value
67
group Id
BG001
value
35
group Id
BG002
value
102
title
75 to < 85 years old
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
≥ 85 years old
title
Age, Customized
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
91
group Id
BG001
value
35
group Id
BG002
value
126
title
Female
measurements
group Id
BG000
value
379
group Id
BG001
value
202
group Id
BG002
value
581
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
12
group Id
BG002
value
30
title
Hispanic or Latino
measurements
group Id
BG000
value
417
group Id
BG001
value
215
group Id
BG002
value
632
title
Not Hispanic or Latino
measurements
group Id
BG000
value
35
group Id
BG001
value
10
group Id
BG002
value
45
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
159
group Id
BG001
value
82
group Id
BG002
value
241
title
Asian
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
8
group Id
BG001
value
11
group Id
BG002
value
19
title
Black or African American
measurements
group Id
BG000
value
264
group Id
BG001
value
130
group Id
BG002
value
394
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
36
group Id
BG001
value
13
group Id
BG002
value
49
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
11
group Id
BG002
value
26
title
Australia / New Zealand
categories
measurements
group Id
BG000
value
116
group Id
BG001
value
59
group Id
BG002
value
175
title
Asia
categories
measurements
group Id
BG000
value
231
group Id
BG001
value
108
group Id
BG002
value
339
title
Europe
categories
measurements
group Id
BG000
value
108
group Id
BG001
value
59
group Id
BG002
value
167
title
North America (USA / Canada)
param Type
COUNT_OF_PARTICIPANTS
title
Geographic Region
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
368
group Id
BG001
value
186
group Id
BG002
value
554
title
Yes
measurements
group Id
BG000
value
102
group Id
BG001
value
51
group Id
BG002
value
153
title
No
description
Interactive voice/web response system (IxRS)
param Type
COUNT_OF_PARTICIPANTS
title
Presence of extrahepatic spread of disease and/or macrovascular invasion (stratification per IxRS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
182
group Id
BG001
value
90
group Id
BG002
value
272
title
HBV (with or without known HCV)
measurements
group Id
BG000
value
100
group Id
BG001
value
51
group Id
BG002
value
151
title
HCV (without known HBV)
measurements
group Id
BG000
value
188
group Id
BG001
value
96
group Id
BG002
value
284
title
Other (neither HBV nor HCV)
param Type
COUNT_OF_PARTICIPANTS
title
Etiology of disease (stratification factor per IxRS),
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
116
group Id
BG001
value
59
group Id
BG002
value
175
title
Asia
measurements
group Id
BG000
value
354
group Id
BG001
value
178
group Id
BG002
value
532
title
Other Regions
param Type
COUNT_OF_PARTICIPANTS
title
Geographic region (stratification factor per IxRS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
245
group Id
BG001
value
131
group Id
BG002
value
376
title
0
measurements
group Id
BG000
value
224
group Id
BG001
value
106
group Id
BG002
value
330
title
1
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
2
description
The ECOG performance scale is: 0 = Normal activity. Fully active, able to carry on all predisease performance without restriction, 1 = Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work), 2 = In bed \< 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
78
group Id
BG001
value
42
group Id
BG002
value
120
title
Current
measurements
group Id
BG000
value
229
group Id
BG001
value
122
group Id
BG002
value
351
title
Former
measurements
group Id
BG000
value
160
group Id
BG001
value
71
group Id
BG002
value
231
title
Never
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Smoking history
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
65
group Id
BG001
value
30
group Id
BG002
value
95
title
Current
measurements
group Id
BG000
value
223
group Id
BG001
value
124
group Id
BG002
value
347
title
Former
measurements
group Id
BG000
value
176
group Id
BG001
value
81
group Id
BG002
value
257
title
Never
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Alcohol use
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice