Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) in the Pediatric Population
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 342 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 chemistry laboratory assessments 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. Unplanned laboratory test results were also included.
Analysis population: Enrolled pediatric (\<18 years old) participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.
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
3
IMT Arm
2
Other Tumors
0
Reported measurements
Anemia
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
Hemoglobin increased
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
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
0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased
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
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
0
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
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
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
Alanine aminotransferase increased
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
Alkaline phosphatase increased
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
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
0
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased
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
Creatinine increased
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
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
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
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
Hypermagnesemia
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
Hypernatremia
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
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
Hypocalcemia
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
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
0
Not reported
Not reported
Not reported
Not reported
Hypokalemia
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
Hypomagnesemia
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
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
Hypophosphatemia
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
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Anemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Hemoglobin increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Lymphocyte count increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
title
Neutrophil count decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Platelet count decreased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
White blood cell decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Alkaline phosphatase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Blood bilirubin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Creatinine increased
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
0
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 chemistry laboratory assessments 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. Unplanned laboratory test results were also included.
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
Enrolled pediatric (\<18 years old) participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.
reporting Status
POSTED
time Frame
From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)
title
Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) in the Pediatric Population
Triangle