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NCT01121588 · OUTCOME

Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries)

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)

What was measured

Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and clinical chemistry parameters were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated.

Analysis population: Number analyzed = Number of participants with a postbaseline value during the study treatment for this outcome measure for each specified row.

Groups in this outcome

ALCL Arm

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.

IMT Arm

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.

Other Tumors

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Reported measurements

Anemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	1	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	5	Not reported	Not reported	Not reported	Not reported

Hemoglobin increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	1	Not reported	Not reported	Not reported	Not reported
IMT Arm	1	Not reported	Not reported	Not reported	Not reported
Other Tumors	4	Not reported	Not reported	Not reported	Not reported

Lymphocyte count increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	8	Not reported	Not reported	Not reported	Not reported
IMT Arm	3	Not reported	Not reported	Not reported	Not reported
Other Tumors	1	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	3	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	1	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	2	Not reported	Not reported	Not reported	Not reported
IMT Arm	1	Not reported	Not reported	Not reported	Not reported
Other Tumors	2	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	4	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	1	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	1	Not reported	Not reported	Not reported	Not reported

Creatinine increased

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hypercalcemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	14

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hyperkalemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	2	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	14

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	1	Not reported	Not reported	Not reported	Not reported

Hypernatremia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	2	Not reported	Not reported	Not reported	Not reported

Hypocalcemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	14

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hypoglycemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	2	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	2	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	14

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	0	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	2	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Analysis denominator · Participants

Group	Source count
ALCL Arm	16
IMT Arm	9
Other Tumors	14

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	3	Not reported	Not reported	Not reported	Not reported
IMT Arm	0	Not reported	Not reported	Not reported	Not reported
Other Tumors	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
5
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Anemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Hemoglobin increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Lymphocyte count increased
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
3
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Neutrophil count decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Platelet count decreased
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
White blood cell decreased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Alkaline phosphatase increased
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Blood bilirubin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants
title
Creatinine increased

denoms

counts
group Id
OG000
value
16
group Id
OG001
value
9
group Id
OG002
value
16
units
Participants

description

Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and clinical chemistry parameters were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated.

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
OG000
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
OG001
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
OG002
title
Other Tumors

param Type

COUNT_OF_PARTICIPANTS

population Description

Number analyzed = Number of participants with a postbaseline value during the study treatment for this outcome measure for each specified row.

reporting Status

POSTED

time Frame

From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)

title

Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice