Number of Participant With Vital Signs and Body Weight Data Meeting Pre-defined Criteria
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
Vital signs data included pulse, systolic blood pressure, and diastolic blood pressure. Measurements were only provided once per timepoint. If multiple assessments were provided per timepoint, the maximum value were used for reporting. The pre-defined criteria of vital sign and body weight data were as follows: maximum pulse rate \>120 beats per minute (bpm); minimum pulse rate \<50 bpm; maximum increase in pulse rate ≥30 bpm; maximum decrease in pulse rate ≥30 bpm; increase in systolic blood Pressure ≥40 mmHg; decrease in systolic blood pressure ≥40 mmHg; decrease in systolic blood pressure ≥60 mmHg; increase in diastolic blood pressure ≥20 mmHg; decrease in diastolic blood pressure ≥20 mmHg; decrease in diastolic blood pressure ≥40 mmHg; increase in body weight ≥10%; increase in body weight ≥20%; decrease in body weight ≥10%.
Analysis population: "Number of Participants Analyzed" included all participants in the safety analysis population. "Number Analyzed" included all participants in the safety analysis population with evaluable data against the pre-defined criteria.
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
Sitting pulse rate: pulse >120 bpm
Analysis denominator · Participants
Group
Source count
Lorlatinib
149
Crizotinib
142
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
7
Not reported
Not reported
Not reported
Not reported
Crizotinib
1
Not reported
Not reported
Not reported
Not reported
Sitting pulse rate: pulse <50 bpm
Analysis denominator · Participants
Group
Source count
Lorlatinib
149
Crizotinib
142
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
4
Not reported
Not reported
Not reported
Not reported
Crizotinib
22
Not reported
Not reported
Not reported
Not reported
Sitting pulse rate: change ≥30 bpm increase
Analysis denominator · Participants
Group
Source count
Lorlatinib
147
Crizotinib
142
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lorlatinib
24
Not reported
Not reported
Not reported
Not reported
Crizotinib
3
Not reported
Not reported
Not reported
Not reported
Sitting pulse rate: change ≥30 bpm decrease
Analysis denominator · Participants
Group
Source count
Lorlatinib
147
Crizotinib
142
Values in Participants · Interval/dispersion: Not reported
Body weight (kg): percent change from baseline ≥10% increase
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
146
group Id
OG001
value
137
units
Participants
title
Body weight (kg): percent change from baseline ≥20% increase
denoms
counts
group Id
OG000
value
149
group Id
OG001
value
142
units
Participants
description
Vital signs data included pulse, systolic blood pressure, and diastolic blood pressure. Measurements were only provided once per timepoint. If multiple assessments were provided per timepoint, the maximum value were used for reporting. The pre-defined criteria of vital sign and body weight data were as follows: maximum pulse rate \>120 beats per minute (bpm); minimum pulse rate \<50 bpm; maximum increase in pulse rate ≥30 bpm; maximum decrease in pulse rate ≥30 bpm; increase in systolic blood Pressure ≥40 mmHg; decrease in systolic blood pressure ≥40 mmHg; decrease in systolic blood pressure ≥60 mmHg; increase in diastolic blood pressure ≥20 mmHg; decrease in diastolic blood pressure ≥20 mmHg; decrease in diastolic blood pressure ≥40 mmHg; increase in body weight ≥10%; increase in body weight ≥20%; decrease in body weight ≥10%.
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
"Number of Participants Analyzed" included all participants in the safety analysis population. "Number Analyzed" included all participants in the safety analysis population with evaluable data against the pre-defined criteria.
reporting Status
POSTED
time Frame
From Baseline up to 33 months
title
Number of Participant With Vital Signs and Body Weight Data Meeting Pre-defined Criteria
Triangle