NCT01121588 · BASELINE

Baseline characteristics

Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) · Source last updated 2025-01-23

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

denoms

counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants

groups

description
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
BG000
title
ALCL Arm
description
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
BG001
title
IMT Arm
description
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
BG002
title
Other Tumors
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
15.0
upper Limit
37.0
value
25.0
group Id
BG001
lower Limit
16.0
upper Limit
73.0
value
32.0
group Id
BG002
lower Limit
18.0
upper Limit
73.0
value
49.0
group Id
BG003
lower Limit
15.0
upper Limit
73.0
value
32.0
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Overall Population
categories
measurements
group Id
BG000
lower Limit
15.0
upper Limit
16.0
value
15.0
group Id
BG001
lower Limit
16.0
upper Limit
17.0
value
16.5
group Id
BG003
lower Limit
15.0
upper Limit
17.0
value
16.0
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Pediatric Population
dispersion Type
FULL_RANGE
param Type
MEDIAN
population Description
The data for age was provided for the overall population and the pediatric population. Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. Number Analyzed for Pediatric Population = Number of participants \<18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study.
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
title
<18
measurements
group Id
BG000
value
14
group Id
BG001
value
6
group Id
BG002
value
15
group Id
BG003
value
35
title
Between 18 and 65 years
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
4
title
>=65 years
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
description
Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study.
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
10
group Id
BG003
value
19
title
Female
measurements
group Id
BG000
value
12
group Id
BG001
value
5
group Id
BG002
value
8
group Id
BG003
value
25
title
Male
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Overall population
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
2
title
Female
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
3
title
Male
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Pediatric Population
param Type
COUNT_OF_PARTICIPANTS
population Description
The data for sex was provided for the overall population and the pediatric population. Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. Number Analyzed for Pediatric Population = Number of participants \<18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study.
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
4
group Id
BG002
value
7
group Id
BG003
value
23
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
White
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Black
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
11
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Asian
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
White
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Black
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
4
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Asia
description
Racial Designation for pediatric population.
param Type
COUNT_OF_PARTICIPANTS
population Description
Number Analyzed for Pediatric Population = Number of participants \<18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study.
title
Race/Ethnicity, Customized
unit Of Measure
Participants

population Description

Baseline population included all enrolled participants who received at least one dose of study intervention.

Complete source fields

denoms

counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants

groups

description
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
BG000
title
ALCL Arm
description
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
BG001
title
IMT Arm
description
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
BG002
title
Other Tumors
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
15.0
upper Limit
37.0
value
25.0
group Id
BG001
lower Limit
16.0
upper Limit
73.0
value
32.0
group Id
BG002
lower Limit
18.0
upper Limit
73.0
value
49.0
group Id
BG003
lower Limit
15.0
upper Limit
73.0
value
32.0
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Overall Population
categories
measurements
group Id
BG000
lower Limit
15.0
upper Limit
16.0
value
15.0
group Id
BG001
lower Limit
16.0
upper Limit
17.0
value
16.5
group Id
BG003
lower Limit
15.0
upper Limit
17.0
value
16.0
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Pediatric Population
dispersion Type
FULL_RANGE
param Type
MEDIAN
population Description
The data for age was provided for the overall population and the pediatric population. Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. Number Analyzed for Pediatric Population = Number of participants \<18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study.
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
title
<18
measurements
group Id
BG000
value
14
group Id
BG001
value
6
group Id
BG002
value
15
group Id
BG003
value
35
title
Between 18 and 65 years
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
4
title
>=65 years
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
description
Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study.
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
10
group Id
BG003
value
19
title
Female
measurements
group Id
BG000
value
12
group Id
BG001
value
5
group Id
BG002
value
8
group Id
BG003
value
25
title
Male
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Overall population
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
2
title
Female
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
3
title
Male
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Pediatric Population
param Type
COUNT_OF_PARTICIPANTS
population Description
The data for sex was provided for the overall population and the pediatric population. Number Analyzed for Overall Population = Number of participants (regardless of age) with the corresponding type(s) of tumor, who were enrolled and treated in this study. Number Analyzed for Pediatric Population = Number of participants \<18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study.
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
4
group Id
BG002
value
7
group Id
BG003
value
23
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
White
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Black
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
11
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
18
group Id
BG003
value
44
units
Participants
title
Asian
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
White
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Black
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
4
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
5
units
Participants
title
Asia
description
Racial Designation for pediatric population.
param Type
COUNT_OF_PARTICIPANTS
population Description
Number Analyzed for Pediatric Population = Number of participants \<18 years of age with the corresponding type(s) of tumor, who were enrolled and treated in this study.
title
Race/Ethnicity, Customized
unit Of Measure
Participants

population Description

Baseline population included all enrolled participants who received at least one dose of study intervention.

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Preserved source evidence · Not medical advice