NCT00932893 · OUTCOME

Number of Participants With Categorical Maximum QTcF for Crizotinib

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2

What was measured

QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (\<) 450 milliseconds (msec), 450 msec to \<480 msec, 480 msec to \<500 msec, and more than or equal to (\>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.

Analysis population: ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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
Crizotinib	155

Reported measurements

<450 msec

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	137	Not reported	Not reported	Not reported	Not reported

450 msec to <480 msec

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	9	Not reported	Not reported	Not reported	Not reported

480 msec to <500 msec

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

>=500 msec

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Crizotinib	8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
137
title
<450 msec
categories
measurements
group Id
OG000
value
9
title
450 msec to <480 msec
categories
measurements
group Id
OG000
value
1
title
480 msec to <500 msec
categories
measurements
group Id
OG000
value
8
title
>=500 msec

denoms

counts
group Id
OG000
value
155
units
Participants

description

groups

description
Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
id
OG000
title
Crizotinib

param Type

NUMBER

population Description

ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.

reporting Status

POSTED

time Frame

Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2

title

Number of Participants With Categorical Maximum QTcF for Crizotinib

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice