NCT01183780 · BASELINE

Baseline characteristics

A Study in Second Line Metastatic Colorectal Cancer · Source last updated 2019-09-25

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

denoms

counts
group Id
BG000
value
536
group Id
BG001
value
536
group Id
BG002
value
1072
units
Participants

groups

description
On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
BG000
title
Ramucirumab + FOLFIRI
description
On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
BG001
title
Placebo + FOLFIRI
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
324
group Id
BG001
value
321
group Id
BG002
value
645
title
Between 18 and 65 years
measurements
group Id
BG000
value
212
group Id
BG001
value
215
group Id
BG002
value
427
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
21.0
upper Limit
83.0
value
62.0
group Id
BG001
lower Limit
33.0
upper Limit
87.0
value
62.0
group Id
BG002
lower Limit
21.0
upper Limit
87.0
value
62.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
247
group Id
BG001
value
210
group Id
BG002
value
457
title
Female
measurements
group Id
BG000
value
289
group Id
BG001
value
326
group Id
BG002
value
615
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
39
group Id
BG002
value
77
title
Hispanic or Latino
measurements
group Id
BG000
value
248
group Id
BG001
value
221
group Id
BG002
value
469
title
Not Hispanic or Latino
measurements
group Id
BG000
value
250
group Id
BG001
value
276
group Id
BG002
value
526
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
1
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
111
group Id
BG001
value
103
group Id
BG002
value
214
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
14
group Id
BG001
value
16
group Id
BG002
value
30
title
Black or African American
measurements
group Id
BG000
value
405
group Id
BG001
value
410
group Id
BG002
value
815
title
White
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
141
group Id
BG001
value
142
group Id
BG002
value
283
title
United States
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Portugal
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Taiwan
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
title
Greece
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
60
group Id
BG002
value
111
title
Spain
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
7
group Id
BG002
value
14
title
Israel
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
20
group Id
BG002
value
37
title
Italy
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
India
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
15
group Id
BG002
value
27
title
France
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Puerto Rico
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
19
group Id
BG002
value
35
title
Australia
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
8
group Id
BG002
value
11
title
Denmark
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

All randomized participants.

Complete source fields

denoms

counts
group Id
BG000
value
536
group Id
BG001
value
536
group Id
BG002
value
1072
units
Participants

groups

description
On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
BG000
title
Ramucirumab + FOLFIRI
description
On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
id
BG001
title
Placebo + FOLFIRI
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
324
group Id
BG001
value
321
group Id
BG002
value
645
title
Between 18 and 65 years
measurements
group Id
BG000
value
212
group Id
BG001
value
215
group Id
BG002
value
427
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
21.0
upper Limit
83.0
value
62.0
group Id
BG001
lower Limit
33.0
upper Limit
87.0
value
62.0
group Id
BG002
lower Limit
21.0
upper Limit
87.0
value
62.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
247
group Id
BG001
value
210
group Id
BG002
value
457
title
Female
measurements
group Id
BG000
value
289
group Id
BG001
value
326
group Id
BG002
value
615
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
39
group Id
BG002
value
77
title
Hispanic or Latino
measurements
group Id
BG000
value
248
group Id
BG001
value
221
group Id
BG002
value
469
title
Not Hispanic or Latino
measurements
group Id
BG000
value
250
group Id
BG001
value
276
group Id
BG002
value
526
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
1
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
111
group Id
BG001
value
103
group Id
BG002
value
214
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
14
group Id
BG001
value
16
group Id
BG002
value
30
title
Black or African American
measurements
group Id
BG000
value
405
group Id
BG001
value
410
group Id
BG002
value
815
title
White
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
141
group Id
BG001
value
142
group Id
BG002
value
283
title
United States
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Portugal
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Taiwan
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
title
Greece
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
60
group Id
BG002
value
111
title
Spain
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
7
group Id
BG002
value
14
title
Israel
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
20
group Id
BG002
value
37
title
Italy
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
India
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
15
group Id
BG002
value
27
title
France
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Puerto Rico
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
19
group Id
BG002
value
35
title
Australia
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
8
group Id
BG002
value
11
title
Denmark
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

All randomized participants.

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

Preserved source evidence · Independent clinical review pending · Not medical advice