Number of Participants With Treatment-Emergent Adverse Events (AEs; All-Causality and Treatment-Related)
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 time of Study Start up to 33 months
What was measured
An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs in the table below were treatment-emergent AEs. Grade 3 and 4 AEs in the table below indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Treatment-related AEs were determined by investigators.
Analysis population: The safety analysis population included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization unless the incorrect treatment(s) were received throughout the dosing period, in which case participants were classified according to the first study treatment received.
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
142
Reported measurements
AEs (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
149
Not reported
Not reported
Not reported
Not reported
Crizotinib
140
Not reported
Not reported
Not reported
Not reported
AEs (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
144
Not reported
Not reported
Not reported
Not reported
Crizotinib
133
Not reported
Not reported
Not reported
Not reported
SAEs (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
51
Not reported
Not reported
Not reported
Not reported
Crizotinib
39
Not reported
Not reported
Not reported
Not reported
SAEs (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
12
Not reported
Not reported
Not reported
Not reported
Crizotinib
7
Not reported
Not reported
Not reported
Not reported
Maximum Grade 3 or 4 AEs (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
108
Not reported
Not reported
Not reported
Not reported
Crizotinib
79
Not reported
Not reported
Not reported
Not reported
Maximum Grade 3 or 4 AEs (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
83
Not reported
Not reported
Not reported
Not reported
Crizotinib
52
Not reported
Not reported
Not reported
Not reported
Maximum Grade 5 AEs (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
7
Not reported
Not reported
Not reported
Not reported
Crizotinib
7
Not reported
Not reported
Not reported
Not reported
Maximum Grade 5 AEs (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
2
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
AEs causing study discontinuation (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
7
Not reported
Not reported
Not reported
Not reported
Crizotinib
8
Not reported
Not reported
Not reported
Not reported
AEs causing study discontinuation (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
2
Not reported
Not reported
Not reported
Not reported
Crizotinib
0
Not reported
Not reported
Not reported
Not reported
AEs causing study treatment discontinuation (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
10
Not reported
Not reported
Not reported
Not reported
Crizotinib
13
Not reported
Not reported
Not reported
Not reported
AEs causing study treatment discontinuation (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
7
Not reported
Not reported
Not reported
Not reported
Crizotinib
7
Not reported
Not reported
Not reported
Not reported
AEs causing dose reduction or temporary discontinuation (all-causality)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
79
Not reported
Not reported
Not reported
Not reported
Crizotinib
71
Not reported
Not reported
Not reported
Not reported
AEs causing dose reduction or temporary discontinuation (treatment-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
60
Not reported
Not reported
Not reported
Not reported
Crizotinib
54
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
149
group Id
OG001
value
140
title
AEs (all-causality)
categories
measurements
group Id
OG000
value
144
group Id
OG001
value
133
title
AEs (treatment-related)
categories
measurements
group Id
OG000
value
51
group Id
OG001
value
39
title
SAEs (all-causality)
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
7
title
SAEs (treatment-related)
categories
measurements
group Id
OG000
value
108
group Id
OG001
value
79
title
Maximum Grade 3 or 4 AEs (all-causality)
categories
measurements
group Id
OG000
value
83
group Id
OG001
value
52
title
Maximum Grade 3 or 4 AEs (treatment-related)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
7
title
Maximum Grade 5 AEs (all-causality)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Maximum Grade 5 AEs (treatment-related)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
8
title
AEs causing study discontinuation (all-causality)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
AEs causing study discontinuation (treatment-related)
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
13
title
AEs causing study treatment discontinuation (all-causality)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
7
title
AEs causing study treatment discontinuation (treatment-related)
denoms
counts
group Id
OG000
value
149
group Id
OG001
value
142
units
Participants
description
An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs in the table below were treatment-emergent AEs. Grade 3 and 4 AEs in the table below indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Treatment-related AEs were determined by investigators.
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
The safety analysis population included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization unless the incorrect treatment(s) were received throughout the dosing period, in which case participants were classified according to the first study treatment received.
reporting Status
POSTED
time Frame
From time of Study Start up to 33 months
title
Number of Participants With Treatment-Emergent Adverse Events (AEs; All-Causality and Treatment-Related)
Triangle