NCT00387764 · OUTCOME

Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer · Source last updated 2014-01-14

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: From Baseline to investigational product discontinuation (up to 6.230 years)

What was measured

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett's formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett's QTc value) were summarized using the following reference ranges: \<450, 450 to 479, 480 to 499, 500 to 549, and \>550 milliseconds.

Analysis population: ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.

Groups in this outcome

Pazopanib 800 mg

Participants received pazopanib 800 milligrams (mg) once daily.

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
Pazopanib 800 mg	77

Reported measurements

Remained or reduced to <450

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pazopanib 800 mg	63	Not reported	Not reported	Not reported	Not reported

Remained at Baseline level of 450-479

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pazopanib 800 mg	2	Not reported	Not reported	Not reported	Not reported

Increased to 450-479

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pazopanib 800 mg	8	Not reported	Not reported	Not reported	Not reported

Increased to 480-499

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pazopanib 800 mg	3	Not reported	Not reported	Not reported	Not reported

Increased to >=500

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pazopanib 800 mg	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
63
title
Remained or reduced to <450
categories
measurements
group Id
OG000
value
2
title
Remained at Baseline level of 450-479
categories
measurements
group Id
OG000
value
8
title
Increased to 450-479
categories
measurements
group Id
OG000
value
3
title
Increased to 480-499
categories
measurements
group Id
OG000
value
1
title
Increased to >=500

denoms

counts
group Id
OG000
value
77
units
Participants

description

groups

description
Participants received pazopanib 800 milligrams (mg) once daily.
id
OG000
title
Pazopanib 800 mg

param Type

NUMBER

population Description

ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.

reporting Status

POSTED

time Frame

From Baseline to investigational product discontinuation (up to 6.230 years)

title

Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice