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NCT01154140 · OUTCOME

Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to follow up period (up to 72 months)

What was measured

Anemia(grade\[g\]1:Less than\[\<\] Lower limit of normal\[LLN\] to 10gram per\[/\] deciliter\[g/dL\],g2:\<10 to 8g/dL,g3:\<8g/dL,g4:lifethreatening);platelet (g1:\<LLN to 75\*10\^3/millimeter\[mm\]\^3,g2:\<75\*10\^3/mm\^3 to 50\*10\^3/mm\^3,g3:\<50\*10\^3/mm\^3 to 25\*10\^3/mm\^3,g4:\<25\*10\^3/mm\^3);lymphopenia(g1:\<LLN to 8\*10\^2/mm\^3,g2:\<8\*10\^2 to 5\*10\^2/mm\^3,g3:\<5\*10\^2 to 2\*10\^2/mm\^3,g4:\<2\*10\^2/mm\^3);neutrophil (Absolute)(g1:\<LLN to 15\*10\^2/mm\^3,g2:\<15\*10\^2 to 10\*10\^2/mm\^3,g3:\<10\*10\^2 to 5\*10\^2/mm\^3,g4:\<5\*10\^2/mm\^3);white blood cell count(g1:\<LLN to 3\*10\^3/mm\^3,g2:\<3\*10\^3 to 2\*10\^3/mm\^3,g3:\<2\*10\^3 to 1\*10\^3/mm\^3,g4:\<1\*10\^3/mm\^3);hemoglobin(g1:increase in hemoglobin level\>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level\>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level\>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.

Analysis population: Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure.

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

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

Analysis denominator · Participants

GroupSource count
Crizotinib170
Chemotherapy165

Reported measurements

Anemia: Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib47.1Not reportedNot reportedNot reportedNot reported
Chemotherapy46.7Not reportedNot reportedNot reportedNot reported
Anemia: Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib13.5Not reportedNot reportedNot reportedNot reported
Chemotherapy27.9Not reportedNot reportedNot reportedNot reported
Anemia: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib0.6Not reportedNot reportedNot reportedNot reported
Chemotherapy10.9Not reportedNot reportedNot reportedNot reported
Hemoglobin increased: Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib6.5Not reportedNot reportedNot reportedNot reported
Chemotherapy3.0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased: Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib0.6Not reportedNot reportedNot reportedNot reported
Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased: Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib3.5Not reportedNot reportedNot reportedNot reported
Chemotherapy1.2Not reportedNot reportedNot reportedNot reported
Lymphopenia: Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib34.1Not reportedNot reportedNot reportedNot reported
Chemotherapy26.1Not reportedNot reportedNot reportedNot reported
Lymphopenia: Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib24.7Not reportedNot reportedNot reportedNot reported
Chemotherapy33.9Not reportedNot reportedNot reportedNot reported
Lymphopenia: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib10.6Not reportedNot reportedNot reportedNot reported
Chemotherapy13.9Not reportedNot reportedNot reportedNot reported
Lymphopenia: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib2.4Not reportedNot reportedNot reportedNot reported
Chemotherapy1.8Not reportedNot reportedNot reportedNot reported
Neutrophils (Absolute): Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib20.6Not reportedNot reportedNot reportedNot reported
Chemotherapy14.5Not reportedNot reportedNot reportedNot reported
Neutrophils (Absolute): Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib20.0Not reportedNot reportedNot reportedNot reported
Chemotherapy26.7Not reportedNot reportedNot reportedNot reported
Neutrophils (Absolute): Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib14.1Not reportedNot reportedNot reportedNot reported
Chemotherapy13.9Not reportedNot reportedNot reportedNot reported
Neutrophils (Absolute): Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib0.6Not reportedNot reportedNot reportedNot reported
Chemotherapy3.6Not reportedNot reportedNot reportedNot reported
Platelets: Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib9.4Not reportedNot reportedNot reportedNot reported
Chemotherapy21.8Not reportedNot reportedNot reportedNot reported
Platelets: Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib2.4Not reportedNot reportedNot reportedNot reported
Chemotherapy7.9Not reportedNot reportedNot reportedNot reported
Platelets: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib0.6Not reportedNot reportedNot reportedNot reported
Chemotherapy7.9Not reportedNot reportedNot reportedNot reported
Platelets: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib0.0Not reportedNot reportedNot reportedNot reported
Chemotherapy0.6Not reportedNot reportedNot reportedNot reported
White blood cells: Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib23.5Not reportedNot reportedNot reportedNot reported
Chemotherapy34.5Not reportedNot reportedNot reportedNot reported
White blood cells: Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib22.9Not reportedNot reportedNot reportedNot reported
Chemotherapy24.2Not reportedNot reportedNot reportedNot reported
White blood cells: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib2.9Not reportedNot reportedNot reportedNot reported
Chemotherapy9.1Not reportedNot reportedNot reportedNot reported
White blood cells: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib0.0Not reportedNot reportedNot reportedNot reported
Chemotherapy0.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47.1
      2. group Id
        OG001
        value
        46.7
    title
    Anemia: Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13.5
      2. group Id
        OG001
        value
        27.9
    title
    Anemia: Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.6
      2. group Id
        OG001
        value
        10.9
    title
    Anemia: Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
      2. group Id
        OG001
        value
        3.0
    title
    Hemoglobin increased: Grade 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.6
      2. group Id
        OG001
        value
        0.0
    title
    Hemoglobin increased: Grade 2
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3.5
      2. group Id
        OG001
        value
        1.2
    title
    Lymphocyte count increased: Grade 2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        34.1
      2. group Id
        OG001
        value
        26.1
    title
    Lymphopenia: Grade 1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        24.7
      2. group Id
        OG001
        value
        33.9
    title
    Lymphopenia: Grade 2
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        10.6
      2. group Id
        OG001
        value
        13.9
    title
    Lymphopenia: Grade 3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2.4
      2. group Id
        OG001
        value
        1.8
    title
    Lymphopenia: Grade 4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        20.6
      2. group Id
        OG001
        value
        14.5
    title
    Neutrophils (Absolute): Grade 1
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
      2. group Id
        OG001
        value
        26.7
    title
    Neutrophils (Absolute): Grade 2
denoms
  1. counts
    1. group Id
      OG000
      value
      170
    2. group Id
      OG001
      value
      165
    units
    Participants
description
Anemia(grade\[g\]1:Less than\[\<\] Lower limit of normal\[LLN\] to 10gram per\[/\] deciliter\[g/dL\],g2:\<10 to 8g/dL,g3:\<8g/dL,g4:lifethreatening);platelet (g1:\<LLN to 75\*10\^3/millimeter\[mm\]\^3,g2:\<75\*10\^3/mm\^3 to 50\*10\^3/mm\^3,g3:\<50\*10\^3/mm\^3 to 25\*10\^3/mm\^3,g4:\<25\*10\^3/mm\^3);lymphopenia(g1:\<LLN to 8\*10\^2/mm\^3,g2:\<8\*10\^2 to 5\*10\^2/mm\^3,g3:\<5\*10\^2 to 2\*10\^2/mm\^3,g4:\<2\*10\^2/mm\^3);neutrophil (Absolute)(g1:\<LLN to 15\*10\^2/mm\^3,g2:\<15\*10\^2 to 10\*10\^2/mm\^3,g3:\<10\*10\^2 to 5\*10\^2/mm\^3,g4:\<5\*10\^2/mm\^3);white blood cell count(g1:\<LLN to 3\*10\^3/mm\^3,g2:\<3\*10\^3 to 2\*10\^3/mm\^3,g3:\<2\*10\^3 to 1\*10\^3/mm\^3,g4:\<1\*10\^3/mm\^3);hemoglobin(g1:increase in hemoglobin level\>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level\>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level\>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.
groups
  1. description
    Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
    id
    OG000
    title
    Crizotinib
  2. description
    Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline up to follow up period (up to 72 months)
title
Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice