NCT01266967 · OUTCOME

Mean Blood Pressure at Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain · Source last updated 2014-05-08

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

Measure: MEAN
Unit: millimeters of mercury (mmHg)
Interval / dispersion: Standard Deviation
Time frame: Baseline; Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36

What was measured

Systolic and diastolic blood pressure were measured for all treated participants.

Analysis population: ATS Population. Only those participants with data available at the indicated time points were analyzed.

Groups in this outcome

GSK2118436 150 mg: No Prior Local Therapy

Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

GSK2118436 150 mg: Prior Local Therapy

Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.

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
GSK2118436 150 mg: No Prior Local Therapy	89
GSK2118436 150 mg: Prior Local Therapy	83

Reported measurements

Diastolic BP, Baseline, n=89,83

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	77.7	8.78	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	77.1	9.73	Not reported	Not reported	Not reported

Diastolic BP, Week 4, n=81, 78

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	74.0	10.12	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	74.6	10.88	Not reported	Not reported	Not reported

Diastolic BP, Week 8, n=70, 73

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	74.6	9.14	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	72.7	9.54	Not reported	Not reported	Not reported

Diastolic BP, Week 12, n=68, 62

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	75.2	7.70	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	74.3	11.64	Not reported	Not reported	Not reported

Diastolic BP, Week 16, n=52, 52

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	73.2	10.01	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	71.4	9.40	Not reported	Not reported	Not reported

Diastolic BP, Week 20, n=29, 34

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	73.6	9.98	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	71.7	9.67	Not reported	Not reported	Not reported

Diastolic BP, Week 24, n=22, 25

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	74.7	7.87	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	72.7	9.99	Not reported	Not reported	Not reported

Diastolic BP, Week 28, n=15, 17

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	73.9	6.98	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	76.5	8.37	Not reported	Not reported	Not reported

Diastolic BP, Week 32, n=9, 7

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	73.1	9.47	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	73.6	9.64	Not reported	Not reported	Not reported

Diastolic BP, Week 36, n=2, 1

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	75.5	7.78	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	93.0	NA	Not reported	Not reported	Standard deviation could not be calculated because only one participant was analyzed in this treatment group at this time point.

Systolic BP, Baseline, n=89, 83

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	126.6	16.73	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	123.9	14.17	Not reported	Not reported	Not reported

Systolic BP, Week 4, n=81, 78

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	122.2	13.68	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	121.9	15.37	Not reported	Not reported	Not reported

Systolic BP, Week 8, n=70, 73

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	123.0	12.71	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	117.3	14.53	Not reported	Not reported	Not reported

Systolic BP, Week 12, 68, 62

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	123.6	14.74	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	120.1	14.21	Not reported	Not reported	Not reported

Systolic BP, Week 16, n=52, 52

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	124.7	17.70	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	119.9	11.67	Not reported	Not reported	Not reported

Systolic BP, Week 20, n=29, 34

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	123.7	16.02	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	118.9	13.51	Not reported	Not reported	Not reported

Systolic BP, Week 24, n=22, 25

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	126.3	17.80	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	120.9	16.63	Not reported	Not reported	Not reported

Systolic BP, Week 28, n=15, 17

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	122.2	17.03	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	120.8	14.32	Not reported	Not reported	Not reported

Systolic BP, Week 32, n=9, 7

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	122.8	14.84	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	117.7	10.01	Not reported	Not reported	Not reported

Systolic BP, Week 36, n=2, 1

Values in millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg: No Prior Local Therapy	119.5	13.44	Not reported	Not reported	Not reported
GSK2118436 150 mg: Prior Local Therapy	128.0	NA	Not reported	Not reported	Standard deviation could not be calculated because only one participant was analyzed in this treatment group at this time point.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
8.78
value
77.7
group Id
OG001
spread
9.73
value
77.1
title
Diastolic BP, Baseline, n=89,83
categories
measurements
group Id
OG000
spread
10.12
value
74.0
group Id
OG001
spread
10.88
value
74.6
title
Diastolic BP, Week 4, n=81, 78
categories
measurements
group Id
OG000
spread
9.14
value
74.6
group Id
OG001
spread
9.54
value
72.7
title
Diastolic BP, Week 8, n=70, 73
categories
measurements
group Id
OG000
spread
7.70
value
75.2
group Id
OG001
spread
11.64
value
74.3
title
Diastolic BP, Week 12, n=68, 62
categories
measurements
group Id
OG000
spread
10.01
value
73.2
group Id
OG001
spread
9.40
value
71.4
title
Diastolic BP, Week 16, n=52, 52
categories
measurements
group Id
OG000
spread
9.98
value
73.6
group Id
OG001
spread
9.67
value
71.7
title
Diastolic BP, Week 20, n=29, 34
categories
measurements
group Id
OG000
spread
7.87
value
74.7
group Id
OG001
spread
9.99
value
72.7
title
Diastolic BP, Week 24, n=22, 25
categories
measurements
group Id
OG000
spread
6.98
value
73.9
group Id
OG001
spread
8.37
value
76.5
title
Diastolic BP, Week 28, n=15, 17
categories
measurements
group Id
OG000
spread
9.47
value
73.1
group Id
OG001
spread
9.64
value
73.6
title
Diastolic BP, Week 32, n=9, 7
categories
measurements
group Id
OG000
spread
7.78
value
75.5
comment
Standard deviation could not be calculated because only one participant was analyzed in this treatment group at this time point.
group Id
OG001
spread
NA
value
93.0
title
Diastolic BP, Week 36, n=2, 1
categories
measurements
group Id
OG000
spread
16.73
value
126.6
group Id
OG001
spread
14.17
value
123.9
title
Systolic BP, Baseline, n=89, 83
categories
measurements
group Id
OG000
spread
13.68
value
122.2
group Id
OG001
spread
15.37
value
121.9
title
Systolic BP, Week 4, n=81, 78

denoms

counts
group Id
OG000
value
89
group Id
OG001
value
83
units
Participants

description

Systolic and diastolic blood pressure were measured for all treated participants.

dispersion Type

Standard Deviation

groups

description
Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
id
OG000
title
GSK2118436 150 mg: No Prior Local Therapy
description
Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
id
OG001
title
GSK2118436 150 mg: Prior Local Therapy

param Type

MEAN

population Description

ATS Population. Only those participants with data available at the indicated time points were analyzed.

reporting Status

POSTED

time Frame

Baseline; Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36

title

Mean Blood Pressure at Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36

type

SECONDARY

unit Of Measure

millimeters of mercury (mmHg)

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Preserved source evidence · Not medical advice