NCT03052608 · OUTCOME
Number of Participant With Maximum Increase From Baseline in Electrocardiogram (ECG) 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
Baseline was defined as the last assessment performed on or prior to date of the first dose of study treatment. Triplicate ECGs were collected in the study and the average of the replicate assessments were used for summary analysis. The pre-defined criteria of ECG data were as follows: change from baseline in QTcF ≥60 msec, ≥30 msec but \<60 msec, \<30 msec; change from baseline in QTcB ≥60 msec, ≥30 msec but \<60 msec, \<30 msec; PR change ≥50% if absolute baseline value was \<200 msec; PR change ≥25% if absolute baseline value was ≥200 msec; QRS change ≥50% if absolute baseline value was \<100 msec; QRS change ≥25% if absolute baseline value was ≥100 msec.
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
Change of QTcF ≥60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 146 |
|---|
| Crizotinib | 138 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
30 msec ≤ Change of QTcF <60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 146 |
|---|
| Crizotinib | 138 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
Change of QTcF <30 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 146 |
|---|
| Crizotinib | 138 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 92 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
Change of QTcB ≥60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 149 |
|---|
| Crizotinib | 141 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
30 msec ≤ Change of QTcB <60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 149 |
|---|
| Crizotinib | 141 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
Change of QTcB <30 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 149 |
|---|
| Crizotinib | 141 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 90 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 100 | Not reported | Not reported | Not reported | Not reported |
|---|
PR change ≥50% if absolute baseline value was <200 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 146 |
|---|
| Crizotinib | 140 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
PR change ≥25% if absolute baseline value was ≥200 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 146 |
|---|
| Crizotinib | 140 |
|---|
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 |
|---|
QRS change ≥50% if absolute baseline value was <100 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 149 |
|---|
| Crizotinib | 141 |
|---|
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 |
|---|
QRS change ≥25% if absolute baseline value was ≥100 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 149 |
|---|
| Crizotinib | 141 |
|---|
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 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- Change of QTcF ≥60 msec
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 41
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- 30 msec ≤ Change of QTcF <60 msec
- categories
- measurements
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 81
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- Change of QTcF <30 msec
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 15
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 141
- units
- Participants
- title
- Change of QTcB ≥60 msec
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 26
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 141
- units
- Participants
- title
- 30 msec ≤ Change of QTcB <60 msec
- categories
- measurements
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 141
- units
- Participants
- title
- Change of QTcB <30 msec
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 140
- units
- Participants
- title
- PR change ≥50% if absolute baseline value was <200 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 140
- units
- Participants
- title
- PR change ≥25% if absolute baseline value was ≥200 msec
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 141
- units
- Participants
- title
- QRS change ≥50% if absolute baseline value was <100 msec
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 141
- units
- Participants
- title
- QRS change ≥25% if absolute baseline value was ≥100 msec
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 142
- units
- Participants
- description
- Baseline was defined as the last assessment performed on or prior to date of the first dose of study treatment. Triplicate ECGs were collected in the study and the average of the replicate assessments were used for summary analysis. The pre-defined criteria of ECG data were as follows: change from baseline in QTcF ≥60 msec, ≥30 msec but \<60 msec, \<30 msec; change from baseline in QTcB ≥60 msec, ≥30 msec but \<60 msec, \<30 msec; PR change ≥50% if absolute baseline value was \<200 msec; PR change ≥25% if absolute baseline value was ≥200 msec; QRS change ≥50% if absolute baseline value was \<100 msec; QRS change ≥25% if absolute baseline value was ≥100 msec.
- 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 Maximum Increase From Baseline in Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle