Number of Participants With Changes in Chemistry 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
Group
Source count
Lorlatinib
149
Crizotinib
141
Reported measurements
Alanine aminotransferase increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
4
Not reported
Not reported
Not reported
Not reported
Crizotinib
5
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Alkaline phosphate increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Alkaline phosphate increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
3
Not reported
Not reported
Not reported
Not reported
Crizotinib
4
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Creatine kinase increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
3
Not reported
Not reported
Not reported
Not reported
Crizotinib
5
Not reported
Not reported
Not reported
Not reported
Creatine kinase increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
2
Not reported
Not reported
Not reported
Not reported
Creatinine increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
1
Not reported
Not reported
Not reported
Not reported
Crizotinib
3
Not reported
Not reported
Not reported
Not reported
Creatinine increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Gamma glutamyl transferase increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
9
Not reported
Not reported
Not reported
Not reported
Crizotinib
8
Not reported
Not reported
Not reported
Not reported
Gamma glutamyl transferase increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Hypercalcemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypercalcemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hyperglycemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
9
Not reported
Not reported
Not reported
Not reported
Crizotinib
3
Not reported
Not reported
Not reported
Not reported
Hyperglycemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
1
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hyperkalemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
2
Not reported
Not reported
Not reported
Not reported
Crizotinib
3
Not reported
Not reported
Not reported
Not reported
Hyperkalemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
2
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
1
Not reported
Not reported
Not reported
Not reported
Crizotinib
9
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Crizotinib
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Hypocalcemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
1
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypocalcemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypoglycemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypoglycemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Hypokalemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
3
Not reported
Not reported
Not reported
Not reported
Hypokalemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Hyponatremia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
5
Not reported
Not reported
Not reported
Not reported
Crizotinib
10
Not reported
Not reported
Not reported
Not reported
Hyponatremia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
3
Not reported
Not reported
Not reported
Not reported
Crizotinib
4
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Lipase increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
8
Not reported
Not reported
Not reported
Not reported
Crizotinib
6
Not reported
Not reported
Not reported
Not reported
Lipase increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
3
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Serum amylase increased (Postbaseline Maximum Grade 3)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
1
Not reported
Not reported
Not reported
Not reported
Crizotinib
2
Not reported
Not reported
Not reported
Not reported
Serum amylase increased (Postbaseline Maximum Grade 4)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
0
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
5
title
Alanine aminotransferase increased (Postbaseline Maximum Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Alanine aminotransferase increased (Postbaseline Maximum Grade 4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Alkaline phosphate increased (Postbaseline Maximum Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Alkaline phosphate increased (Postbaseline Maximum Grade 4)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
title
Aspartate aminotransferase increased (Postbaseline Maximum Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Aspartate aminotransferase increased (Postbaseline Maximum Grade 4)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Blood bilirubin increased (Postbaseline Maximum Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Blood bilirubin increased (Postbaseline Maximum Grade 4)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
title
Creatine kinase increased (Postbaseline Maximum Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Creatine kinase increased (Postbaseline Maximum Grade 4)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
title
Creatinine increased (Postbaseline Maximum Grade 3)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Creatinine increased (Postbaseline Maximum Grade 4)
denoms
counts
group Id
OG000
value
149
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
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
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 Chemistry Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
Triangle