NCT00142116 · OUTCOME

Time to Progression

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia · Source last updated 2014-06-02

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

Measure: MEDIAN
Unit: months
Interval / dispersion: Full Range
Time frame: 49.1 months

What was measured

Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.

Groups in this outcome

Thalidomide and Rituximab

Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later. Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks. Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.

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
Thalidomide and Rituximab	25

Reported measurements

TTP for all evaluable patients

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Thalidomide and Rituximab	34.8	Not reported	1.0	49.1	Not reported

TTP for responding patients

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Thalidomide and Rituximab	38.7	Not reported	10.3	49.1	Not reported

TTP for previously treated patients

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Thalidomide and Rituximab	15.25	Not reported	1.0	45.8	Not reported

TTP for previously untreated patients

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Thalidomide and Rituximab	36.04	Not reported	2.5	49.1	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.0
upper Limit
49.1
value
34.8
title
TTP for all evaluable patients
categories
measurements
group Id
OG000
lower Limit
10.3
upper Limit
49.1
value
38.7
title
TTP for responding patients
categories
measurements
group Id
OG000
lower Limit
1.0
upper Limit
45.8
value
15.25
title
TTP for previously treated patients
categories
measurements
group Id
OG000
lower Limit
2.5
upper Limit
49.1
value
36.04
title
TTP for previously untreated patients

denoms

counts
group Id
OG000
value
25
units
Participants

description

Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.

dispersion Type

Full Range

groups

description
Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later. Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks. Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
id
OG000
title
Thalidomide and Rituximab

param Type

MEDIAN

reporting Status

POSTED

time Frame

49.1 months

title

Time to Progression

type

PRIMARY

unit Of Measure

months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice