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NCT03052608 · OUTCOME

Number of Participants With Suicidal Ideation and Suicidal Behavior Across Time

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: Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1, C22D1, C24D1, C26D1, C28D1, C30D1, C32D1, C34D1, C36D1, C38D1 and End of Treatment

What was measured

Suicidal ideation and behaviors were assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events and provides a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation, and deterrents), all of which are significantly predictive of completed suicide.

Analysis population: "Number of Participants Analyzed" included all participants in the safety analysis population within each treatment group. "Number Analyzed" included all participants with assessment scores at each specified time point.

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

Baseline

Analysis denominator · Participants

Group	Source count
Lorlatinib	147
Crizotinib	121

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	3	Not reported	Not reported	Not reported	Not reported
Crizotinib	7	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	138
Crizotinib	119

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0	Not reported	Not reported	Not reported	Not reported
Crizotinib	5	Not reported	Not reported	Not reported	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	137
Crizotinib	113

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	1	Not reported	Not reported	Not reported	Not reported
Crizotinib	1	Not reported	Not reported	Not reported	Not reported

Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	131
Crizotinib	109

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

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	128
Crizotinib	103

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

Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	123
Crizotinib	93

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

Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	122
Crizotinib	85

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

Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	115
Crizotinib	68

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

Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	114
Crizotinib	55

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

Cycle 14 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	109
Crizotinib	44

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

Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	103
Crizotinib	35

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

Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	81
Crizotinib	25

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

Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	67
Crizotinib	15

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

Cycle 22 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	54
Crizotinib	13

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

Cycle 24 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	41
Crizotinib	9

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

Cycle 26 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	33
Crizotinib	8

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

Cycle 28 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	23
Crizotinib	6

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

Cycle 30 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	14
Crizotinib	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

Cycle 32 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	10
Crizotinib	2

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

Cycle 34 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	6
Crizotinib	1

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

Cycle 36 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	2
Crizotinib	1

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

Cycle 38 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	1
Crizotinib	0

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0	Not reported	Not reported	Not reported	Not reported

End of Treatment

Analysis denominator · Participants

Group	Source count
Lorlatinib	20
Crizotinib	62

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
3
group Id
OG001
value
7
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
121
units
Participants
title
Baseline
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
138
group Id
OG001
value
119
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
137
group Id
OG001
value
113
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
131
group Id
OG001
value
109
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
128
group Id
OG001
value
103
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
93
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
85
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
115
group Id
OG001
value
68
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
114
group Id
OG001
value
55
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
109
group Id
OG001
value
44
units
Participants
title
Cycle 14 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
103
group Id
OG001
value
35
units
Participants
title
Cycle 16 Day 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
81
group Id
OG001
value
25
units
Participants
title
Cycle 18 Day 1

denoms

counts
group Id
OG000
value
149
group Id
OG001
value
142
units
Participants

description

Suicidal ideation and behaviors were assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events and provides a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation, and deterrents), all of which are significantly predictive of completed suicide.

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 within each treatment group. "Number Analyzed" included all participants with assessment scores at each specified time point.

reporting Status

POSTED

time Frame

Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1, C22D1, C24D1, C26D1, C28D1, C30D1, C32D1, C34D1, C36D1, C38D1 and End of Treatment

title

Number of Participants With Suicidal Ideation and Suicidal Behavior Across Time

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice