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NCT03052608 · OUTCOME

Number of Participants With Changes in Lipid Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25

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 Baseline up to 33 months

What was measured

Laboratory test results were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grades 1 and 2 indicate mild and moderate AE, respectively; Grades 3 and 4 indicate severe AE and life-threatening consequences respectively; Grade 5 indicates death due to AE. Participants with laboratory test abnormalities were summarized according to the worst grade for each laboratory test result. All participants meeting the postbaseline grade criteria in the table below had baseline maximum grades lower than 3.

Analysis population: Participants in the safety analysis population who had at least one on-study assessment for the parameter of interest.

Groups in this outcome

Lorlatinib

Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

Crizotinib

Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Lorlatinib149
Crizotinib141

Reported measurements

Cholesterol high (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lorlatinib26Not reportedNot reportedNot reportedNot reported
Crizotinib0Not reportedNot reportedNot reportedNot reported
Cholesterol high (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lorlatinib3Not reportedNot reportedNot reportedNot reported
Crizotinib0Not reportedNot reportedNot reportedNot reported
Hypertriglyceridemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lorlatinib20Not reportedNot reportedNot reportedNot reported
Crizotinib0Not reportedNot reportedNot reportedNot reported
Hypertriglyceridemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lorlatinib13Not reportedNot reportedNot reportedNot reported
Crizotinib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        0
    title
    Cholesterol high (Postbaseline Maximum Grade 3)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Cholesterol high (Postbaseline Maximum Grade 4)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
    title
    Hypertriglyceridemia (Postbaseline Maximum Grade 3)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
    title
    Hypertriglyceridemia (Postbaseline Maximum Grade 4)
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    2. group Id
      OG001
      value
      141
    units
    Participants
description
Laboratory test results were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grades 1 and 2 indicate mild and moderate AE, respectively; Grades 3 and 4 indicate severe AE and life-threatening consequences respectively; Grade 5 indicates death due to AE. Participants with laboratory test abnormalities were summarized according to the worst grade for each laboratory test result. All participants meeting the postbaseline grade criteria in the table below had baseline maximum grades lower than 3.
groups
  1. description
    Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    OG000
    title
    Lorlatinib
  2. description
    Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    OG001
    title
    Crizotinib
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants in the safety analysis population who had at least one on-study assessment for the parameter of interest.
reporting Status
POSTED
time Frame
From Baseline up to 33 months
title
Number of Participants With Changes in Lipid Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice