NCT02569242 · BASELINE

Baseline characteristics

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer · Source last updated 2022-07-06

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

denoms

counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants

groups

description
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
id
BG000
title
Nivolumab Arm
description
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
id
BG001
title
Active Comparator Arm （Docetaxel/Paclitaxel）
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
112
group Id
BG001
value
85
group Id
BG002
value
197
title
Between 18 and 65 years
measurements
group Id
BG000
value
98
group Id
BG001
value
124
group Id
BG002
value
222
title
>=65 years
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
57
upper Limit
69
value
64
group Id
BG001
lower Limit
57
upper Limit
72
value
67
group Id
BG002
lower Limit
57
upper Limit
71
value
65
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
dispersion Type
INTER_QUARTILE_RANGE
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
24
group Id
BG002
value
55
title
Female
measurements
group Id
BG000
value
179
group Id
BG001
value
185
group Id
BG002
value
364
title
Male
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
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
201
group Id
BG001
value
200
group Id
BG002
value
401
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
9
group Id
BG001
value
9
group Id
BG002
value
18
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
201
group Id
BG001
value
200
group Id
BG002
value
401
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Asian
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
9
group Id
BG002
value
18
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
White
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
107
group Id
BG002
value
208
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
0
categories
measurements
group Id
BG000
value
109
group Id
BG001
value
102
group Id
BG002
value
211
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
1
description
performance status 0；Fully active, able to continue all pre-disease activities without restriction performance status 1；Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
param Type
COUNT_OF_PARTICIPANTS
title
ECOG performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
107
group Id
BG001
value
120
group Id
BG002
value
227
units
Participants
title
II - III
categories
measurements
group Id
BG000
value
94
group Id
BG001
value
100
group Id
BG002
value
194
denoms
counts
group Id
BG000
value
107
group Id
BG001
value
120
group Id
BG002
value
227
units
Participants
title
IV
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
107
group Id
BG001
value
120
group Id
BG002
value
227
units
Participants
title
unknown
description
In this study, the TNM Classification of Malignant Tumours, Seventh Edition, published by the Union for International Cancer Control (UICC) (hereinafter referred to as "the TNM classification") will be used to determine disease stage. please refer to the protocol information. Higher numbers mean the cancer is more advanced.
param Type
COUNT_OF_PARTICIPANTS
population Description
Summarized for subjects with non-recurrent esophageal cancer.
title
Disease stage : TNM classification
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
111
group Id
BG001
value
94
group Id
BG002
value
205
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Surgery
categories
measurements
group Id
BG000
value
153
group Id
BG001
value
142
group Id
BG002
value
295
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Radiothrapy
categories
measurements
group Id
BG000
value
210
group Id
BG001
value
208
group Id
BG002
value
418
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Systemic anticancer therapy
param Type
COUNT_OF_PARTICIPANTS
title
Previous therapies
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
91
group Id
BG002
value
180
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<=1
categories
measurements
group Id
BG000
value
121
group Id
BG001
value
118
group Id
BG002
value
239
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=2
param Type
COUNT_OF_PARTICIPANTS
title
Number of organs of metastases
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
159
group Id
BG001
value
163
group Id
BG002
value
322
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Lymph node
categories
measurements
group Id
BG000
value
57
group Id
BG001
value
54
group Id
BG002
value
111
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Liver
categories
measurements
group Id
BG000
value
98
group Id
BG001
value
92
group Id
BG002
value
190
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Lung
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
25
group Id
BG002
value
48
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Bone
param Type
COUNT_OF_PARTICIPANTS
title
Site of metastases
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
109
group Id
BG001
value
107
group Id
BG002
value
216
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<1%
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
102
group Id
BG002
value
203
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=1%
categories
measurements
group Id
BG000
value
136
group Id
BG001
value
137
group Id
BG002
value
273
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<5%
categories
measurements
group Id
BG000
value
74
group Id
BG001
value
72
group Id
BG002
value
146
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=5%
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
152
group Id
BG002
value
298
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<10%
categories
measurements
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=10%
description
In this study, the subject will test positive for PD-L1 when cancerous cells with stained cell membranes account for ≧1% of at least 100 evaluable cancerous cells and will test negative for PD-L1 when such cells account for \<1%, the same applies to 5% and 10%.
param Type
COUNT_OF_PARTICIPANTS
title
PD-L1 expression
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
32
group Id
BG002
value
62
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Never
categories
measurements
group Id
BG000
value
159
group Id
BG001
value
147
group Id
BG002
value
306
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Former
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
30
group Id
BG002
value
51
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Current
param Type
COUNT_OF_PARTICIPANTS
title
History of smoking
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants

groups

description
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
id
BG000
title
Nivolumab Arm
description
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
id
BG001
title
Active Comparator Arm （Docetaxel/Paclitaxel）
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
112
group Id
BG001
value
85
group Id
BG002
value
197
title
Between 18 and 65 years
measurements
group Id
BG000
value
98
group Id
BG001
value
124
group Id
BG002
value
222
title
>=65 years
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
57
upper Limit
69
value
64
group Id
BG001
lower Limit
57
upper Limit
72
value
67
group Id
BG002
lower Limit
57
upper Limit
71
value
65
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
dispersion Type
INTER_QUARTILE_RANGE
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
24
group Id
BG002
value
55
title
Female
measurements
group Id
BG000
value
179
group Id
BG001
value
185
group Id
BG002
value
364
title
Male
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
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
201
group Id
BG001
value
200
group Id
BG002
value
401
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
9
group Id
BG001
value
9
group Id
BG002
value
18
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
201
group Id
BG001
value
200
group Id
BG002
value
401
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Asian
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
9
group Id
BG002
value
18
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
White
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
107
group Id
BG002
value
208
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
0
categories
measurements
group Id
BG000
value
109
group Id
BG001
value
102
group Id
BG002
value
211
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
1
description
performance status 0；Fully active, able to continue all pre-disease activities without restriction performance status 1；Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
param Type
COUNT_OF_PARTICIPANTS
title
ECOG performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
107
group Id
BG001
value
120
group Id
BG002
value
227
units
Participants
title
II - III
categories
measurements
group Id
BG000
value
94
group Id
BG001
value
100
group Id
BG002
value
194
denoms
counts
group Id
BG000
value
107
group Id
BG001
value
120
group Id
BG002
value
227
units
Participants
title
IV
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
107
group Id
BG001
value
120
group Id
BG002
value
227
units
Participants
title
unknown
description
In this study, the TNM Classification of Malignant Tumours, Seventh Edition, published by the Union for International Cancer Control (UICC) (hereinafter referred to as "the TNM classification") will be used to determine disease stage. please refer to the protocol information. Higher numbers mean the cancer is more advanced.
param Type
COUNT_OF_PARTICIPANTS
population Description
Summarized for subjects with non-recurrent esophageal cancer.
title
Disease stage : TNM classification
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
111
group Id
BG001
value
94
group Id
BG002
value
205
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Surgery
categories
measurements
group Id
BG000
value
153
group Id
BG001
value
142
group Id
BG002
value
295
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Radiothrapy
categories
measurements
group Id
BG000
value
210
group Id
BG001
value
208
group Id
BG002
value
418
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Systemic anticancer therapy
param Type
COUNT_OF_PARTICIPANTS
title
Previous therapies
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
91
group Id
BG002
value
180
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<=1
categories
measurements
group Id
BG000
value
121
group Id
BG001
value
118
group Id
BG002
value
239
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=2
param Type
COUNT_OF_PARTICIPANTS
title
Number of organs of metastases
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
159
group Id
BG001
value
163
group Id
BG002
value
322
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Lymph node
categories
measurements
group Id
BG000
value
57
group Id
BG001
value
54
group Id
BG002
value
111
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Liver
categories
measurements
group Id
BG000
value
98
group Id
BG001
value
92
group Id
BG002
value
190
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Lung
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
25
group Id
BG002
value
48
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Bone
param Type
COUNT_OF_PARTICIPANTS
title
Site of metastases
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
109
group Id
BG001
value
107
group Id
BG002
value
216
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<1%
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
102
group Id
BG002
value
203
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=1%
categories
measurements
group Id
BG000
value
136
group Id
BG001
value
137
group Id
BG002
value
273
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<5%
categories
measurements
group Id
BG000
value
74
group Id
BG001
value
72
group Id
BG002
value
146
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=5%
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
152
group Id
BG002
value
298
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
<10%
categories
measurements
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
>=10%
description
In this study, the subject will test positive for PD-L1 when cancerous cells with stained cell membranes account for ≧1% of at least 100 evaluable cancerous cells and will test negative for PD-L1 when such cells account for \<1%, the same applies to 5% and 10%.
param Type
COUNT_OF_PARTICIPANTS
title
PD-L1 expression
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
32
group Id
BG002
value
62
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Never
categories
measurements
group Id
BG000
value
159
group Id
BG001
value
147
group Id
BG002
value
306
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Former
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
30
group Id
BG002
value
51
denoms
counts
group Id
BG000
value
210
group Id
BG001
value
209
group Id
BG002
value
419
units
Participants
title
Current
param Type
COUNT_OF_PARTICIPANTS
title
History of smoking
unit Of Measure
Participants

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Preserved source evidence · Not medical advice