NCT00934544 · OUTCOME

Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis)

Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial · Source last updated 2019-08-19

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

Measure: NUMBER
Unit: probability of response
Interval / dispersion: 95% Confidence Interval
Time frame: Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume

What was measured

This is defined as the interval between randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume

Analysis population: Full analysis set (FAS)

Groups in this outcome

Ruxolitinib

5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule

Best Available Therapy (BAT)

Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

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
Ruxolitinib	69
Best Available Therapy (BAT)	1

Reported measurements

12 weeks

Values in probability of response · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.23	Not reported	0.14	0.34	Not reported
Best Available Therapy (BAT)	0	Not reported	NA	NA	There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate

24 weeks

Values in probability of response · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.67	Not reported	0.54	0.76	Not reported
Best Available Therapy (BAT)	1	Not reported	NA	NA	There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate

36 weeks

Values in probability of response · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.87	Not reported	0.76	0.93	Not reported
Best Available Therapy (BAT)	1	Not reported	NA	NA	There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate

48 weeks

Values in probability of response · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.97	Not reported	0.89	0.99	Not reported
Best Available Therapy (BAT)	1	Not reported	NA	NA	There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.14
upper Limit
0.34
value
0.23
comment
There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate
group Id
OG001
lower Limit
NA
upper Limit
NA
value
0
title
12 weeks
categories
measurements
group Id
OG000
lower Limit
0.54
upper Limit
0.76
value
0.67
comment
There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate
group Id
OG001
lower Limit
NA
upper Limit
NA
value
1
title
24 weeks
categories
measurements
group Id
OG000
lower Limit
0.76
upper Limit
0.93
value
0.87
comment
There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate
group Id
OG001
lower Limit
NA
upper Limit
NA
value
1
title
36 weeks
categories
measurements
group Id
OG000
lower Limit
0.89
upper Limit
0.99
value
0.97
comment
There was only one BAT patient responder (≥ 35% reduction in spleen volume) but no consecutive readings to determine any value for duration of response - no Median or CI possible to calculate
group Id
OG001
lower Limit
NA
upper Limit
NA
value
1
title
48 weeks

denoms

counts
group Id
OG000
value
69
group Id
OG001
value
1
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
id
OG000
title
Ruxolitinib
description
Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
id
OG001
title
Best Available Therapy (BAT)

param Type

NUMBER

population Description

Full analysis set (FAS)

reporting Status

POSTED

time Frame

Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume

title

Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis)

type

SECONDARY

unit Of Measure

probability of response

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Preserved source evidence · Not medical advice