NCT00561470 · BASELINE

Baseline characteristics

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen · Source last updated 2012-09-28

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

denoms

counts
group Id
BG000
value
614
group Id
BG001
value
612
group Id
BG002
value
1226
units
Participants

groups

description
Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
id
BG000
title
Placebo/Folfiri
description
Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
id
BG001
title
Aflibercept/Folfiri
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
10.8
value
60.2
group Id
BG001
spread
10.5
value
59.5
group Id
BG002
spread
10.7
value
59.8
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
376
group Id
BG001
value
407
group Id
BG002
value
783
title
<65 years
categories
measurements
group Id
BG000
value
199
group Id
BG001
value
172
group Id
BG002
value
371
title
>=65 but <75 years
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
33
group Id
BG002
value
72
title
>=75 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
353
group Id
BG001
value
365
group Id
BG002
value
718
title
Male
categories
measurements
group Id
BG000
value
261
group Id
BG001
value
247
group Id
BG002
value
508
title
Female
param Type
NUMBER
title
Sex/Gender, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
523
group Id
BG001
value
548
group Id
BG002
value
1071
title
Caucasian/White
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
16
group Id
BG002
value
43
title
Black
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
35
group Id
BG002
value
86
title
Asian/Oriental
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
13
group Id
BG002
value
26
title
Other
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
ARGENTINA
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
54
group Id
BG002
value
96
title
AUSTRALIA
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
AUSTRIA
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
45
group Id
BG002
value
82
title
BELGIUM
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
27
group Id
BG002
value
48
title
BRAZIL
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
33
group Id
BG002
value
64
title
CHILE
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
47
group Id
BG002
value
77
title
CZECH REPUBLIC
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
DENMARK
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
3
group Id
BG002
value
10
title
ESTONIA
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
FRANCE
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
12
group Id
BG002
value
35
title
GERMANY
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
19
title
GREECE
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
350
group Id
BG001
value
349
group Id
BG002
value
699
title
Participants with ECOG Score = 0
categories
measurements
group Id
BG000
value
250
group Id
BG001
value
250
group Id
BG002
value
500
title
Participants with ECOG Score = 1
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
27
title
Participants with ECOG Score = 2
description
The ECOG score assesses how the disease affects a participant's daily living abilities. It ranges from 0-5, with 0 being the best and 5 being the worst outcome. "0" reflects a fully active participant, able to carry on all pre-disease performance without restriction. "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. "2" reflects an ambulatory participant, who is up and about more than 50% of waking hours, and capable of all self-care but unable to carry out any work activities.
param Type
NUMBER
title
Eastern Cooperative Oncology Group (ECOG) performance status score
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
187
group Id
BG001
value
186
group Id
BG002
value
373
title
Yes
categories
measurements
group Id
BG000
value
427
group Id
BG001
value
426
group Id
BG002
value
853
title
No
description
Number of participants randomized in the prior bevacizumab stratum as per the interactive voice response system (IVRS).
param Type
NUMBER
title
Prior Bevacizumab
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
614
group Id
BG001
value
612
group Id
BG002
value
1226
units
Participants

groups

description
Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
id
BG000
title
Placebo/Folfiri
description
Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
id
BG001
title
Aflibercept/Folfiri
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
10.8
value
60.2
group Id
BG001
spread
10.5
value
59.5
group Id
BG002
spread
10.7
value
59.8
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
376
group Id
BG001
value
407
group Id
BG002
value
783
title
<65 years
categories
measurements
group Id
BG000
value
199
group Id
BG001
value
172
group Id
BG002
value
371
title
>=65 but <75 years
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
33
group Id
BG002
value
72
title
>=75 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
353
group Id
BG001
value
365
group Id
BG002
value
718
title
Male
categories
measurements
group Id
BG000
value
261
group Id
BG001
value
247
group Id
BG002
value
508
title
Female
param Type
NUMBER
title
Sex/Gender, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
523
group Id
BG001
value
548
group Id
BG002
value
1071
title
Caucasian/White
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
16
group Id
BG002
value
43
title
Black
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
35
group Id
BG002
value
86
title
Asian/Oriental
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
13
group Id
BG002
value
26
title
Other
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
ARGENTINA
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
54
group Id
BG002
value
96
title
AUSTRALIA
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
AUSTRIA
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
45
group Id
BG002
value
82
title
BELGIUM
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
27
group Id
BG002
value
48
title
BRAZIL
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
33
group Id
BG002
value
64
title
CHILE
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
47
group Id
BG002
value
77
title
CZECH REPUBLIC
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
DENMARK
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
3
group Id
BG002
value
10
title
ESTONIA
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
FRANCE
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
12
group Id
BG002
value
35
title
GERMANY
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
19
title
GREECE
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
350
group Id
BG001
value
349
group Id
BG002
value
699
title
Participants with ECOG Score = 0
categories
measurements
group Id
BG000
value
250
group Id
BG001
value
250
group Id
BG002
value
500
title
Participants with ECOG Score = 1
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
27
title
Participants with ECOG Score = 2
description
The ECOG score assesses how the disease affects a participant's daily living abilities. It ranges from 0-5, with 0 being the best and 5 being the worst outcome. "0" reflects a fully active participant, able to carry on all pre-disease performance without restriction. "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. "2" reflects an ambulatory participant, who is up and about more than 50% of waking hours, and capable of all self-care but unable to carry out any work activities.
param Type
NUMBER
title
Eastern Cooperative Oncology Group (ECOG) performance status score
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
187
group Id
BG001
value
186
group Id
BG002
value
373
title
Yes
categories
measurements
group Id
BG000
value
427
group Id
BG001
value
426
group Id
BG002
value
853
title
No
description
Number of participants randomized in the prior bevacizumab stratum as per the interactive voice response system (IVRS).
param Type
NUMBER
title
Prior Bevacizumab
unit Of Measure
participants

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

Preserved source evidence · Not medical advice