NCT00405756 · BASELINE

Baseline characteristics

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older. · Source last updated 2017-01-11

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

denoms

counts
group Id
BG000
value
152
group Id
BG001
value
153
group Id
BG002
value
154
group Id
BG003
value
459
units
Participants

groups

description
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
BG000
title
MPR+R
description
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
BG001
title
MPR+p
description
Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
BG002
title
MPp+p
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.33
value
72.0
group Id
BG001
spread
5.20
value
72.1
group Id
BG002
spread
5.26
value
72.0
group Id
BG003
spread
5.25
value
72.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
116
group Id
BG001
value
116
group Id
BG002
value
116
group Id
BG003
value
348
title
<=75 years
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
37
group Id
BG002
value
38
group Id
BG003
value
111
title
>75 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
71
group Id
BG002
value
79
group Id
BG003
value
231
title
Female
measurements
group Id
BG000
value
71
group Id
BG001
value
82
group Id
BG002
value
75
group Id
BG003
value
228
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Gender
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
151
group Id
BG001
value
151
group Id
BG002
value
151
group Id
BG003
value
453
title
White
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Black
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Hispanic
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Asian / Pacific Islander
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
American Indian or Alaska Native
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
4
title
Other
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
14.77
value
73.5
group Id
BG001
spread
12.79
value
72.0
group Id
BG002
spread
15.20
value
72.1
group Id
BG003
spread
14.28
value
72.5
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kilograms
classes
categories
measurements
group Id
BG000
spread
9.81
value
164.8
group Id
BG001
spread
9.33
value
165.3
group Id
BG002
spread
9.79
value
165.7
group Id
BG003
spread
9.63
value
165.3
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Height
unit Of Measure
centimeter
classes
categories
measurements
group Id
BG000
spread
17.71
value
133.9
group Id
BG001
spread
18.60
value
135.5
group Id
BG002
spread
20.13
value
136.4
group Id
BG003
spread
18.83
value
135.3
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Systolic Blood Pressure
unit Of Measure
mmHg
classes
categories
measurements
group Id
BG000
spread
9.53
value
78.5
group Id
BG001
spread
9.99
value
77.4
group Id
BG002
spread
10.40
value
78.8
group Id
BG003
spread
9.98
value
78.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Diastolic Blood Pressure
unit Of Measure
mmHg
classes
categories
measurements
group Id
BG000
spread
0.41
value
36.5
group Id
BG001
spread
0.38
value
36.5
group Id
BG002
spread
0.40
value
36.5
group Id
BG003
spread
0.40
value
36.5
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Temperature
unit Of Measure
degrees centigrade
classes
categories
measurements
group Id
BG000
spread
9.77
value
76.0
group Id
BG001
spread
10.50
value
77.3
group Id
BG002
spread
10.80
value
76.3
group Id
BG003
spread
10.36
value
76.5
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Pulse
unit Of Measure
beats per minute
classes
categories
measurements
group Id
BG000
spread
11.95
value
81.1
group Id
BG001
spread
11.71
value
82.2
group Id
BG002
spread
11.46
value
84.0
group Id
BG003
spread
11.74
value
82.4
description
Karnofsky Performance Scale classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the greater the impairment and worse prospect of survival for most serious illnesses.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Karnofsky Performance Scale
unit Of Measure
units on a scale
classes
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
32
group Id
BG002
value
28
group Id
BG003
value
88
title
Stage I
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
47
group Id
BG002
value
48
group Id
BG003
value
145
title
Stage II
categories
measurements
group Id
BG000
value
74
group Id
BG001
value
74
group Id
BG002
value
78
group Id
BG003
value
226
title
Stage III
description
ISS form multiple myeloma divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Higher stages represent more advanced disease.
param Type
NUMBER
title
International Staging System (ISS)
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
152
group Id
BG001
value
153
group Id
BG002
value
154
group Id
BG003
value
459
units
Participants

groups

description
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
BG000
title
MPR+R
description
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
BG001
title
MPR+p
description
Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
BG002
title
MPp+p
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.33
value
72.0
group Id
BG001
spread
5.20
value
72.1
group Id
BG002
spread
5.26
value
72.0
group Id
BG003
spread
5.25
value
72.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
116
group Id
BG001
value
116
group Id
BG002
value
116
group Id
BG003
value
348
title
<=75 years
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
37
group Id
BG002
value
38
group Id
BG003
value
111
title
>75 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
71
group Id
BG002
value
79
group Id
BG003
value
231
title
Female
measurements
group Id
BG000
value
71
group Id
BG001
value
82
group Id
BG002
value
75
group Id
BG003
value
228
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Gender
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
151
group Id
BG001
value
151
group Id
BG002
value
151
group Id
BG003
value
453
title
White
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Black
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Hispanic
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Asian / Pacific Islander
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
American Indian or Alaska Native
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
4
title
Other
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
14.77
value
73.5
group Id
BG001
spread
12.79
value
72.0
group Id
BG002
spread
15.20
value
72.1
group Id
BG003
spread
14.28
value
72.5
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kilograms
classes
categories
measurements
group Id
BG000
spread
9.81
value
164.8
group Id
BG001
spread
9.33
value
165.3
group Id
BG002
spread
9.79
value
165.7
group Id
BG003
spread
9.63
value
165.3
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Height
unit Of Measure
centimeter
classes
categories
measurements
group Id
BG000
spread
17.71
value
133.9
group Id
BG001
spread
18.60
value
135.5
group Id
BG002
spread
20.13
value
136.4
group Id
BG003
spread
18.83
value
135.3
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Systolic Blood Pressure
unit Of Measure
mmHg
classes
categories
measurements
group Id
BG000
spread
9.53
value
78.5
group Id
BG001
spread
9.99
value
77.4
group Id
BG002
spread
10.40
value
78.8
group Id
BG003
spread
9.98
value
78.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Diastolic Blood Pressure
unit Of Measure
mmHg
classes
categories
measurements
group Id
BG000
spread
0.41
value
36.5
group Id
BG001
spread
0.38
value
36.5
group Id
BG002
spread
0.40
value
36.5
group Id
BG003
spread
0.40
value
36.5
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Temperature
unit Of Measure
degrees centigrade
classes
categories
measurements
group Id
BG000
spread
9.77
value
76.0
group Id
BG001
spread
10.50
value
77.3
group Id
BG002
spread
10.80
value
76.3
group Id
BG003
spread
10.36
value
76.5
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Pulse
unit Of Measure
beats per minute
classes
categories
measurements
group Id
BG000
spread
11.95
value
81.1
group Id
BG001
spread
11.71
value
82.2
group Id
BG002
spread
11.46
value
84.0
group Id
BG003
spread
11.74
value
82.4
description
Karnofsky Performance Scale classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the greater the impairment and worse prospect of survival for most serious illnesses.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Karnofsky Performance Scale
unit Of Measure
units on a scale
classes
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
32
group Id
BG002
value
28
group Id
BG003
value
88
title
Stage I
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
47
group Id
BG002
value
48
group Id
BG003
value
145
title
Stage II
categories
measurements
group Id
BG000
value
74
group Id
BG001
value
74
group Id
BG002
value
78
group Id
BG003
value
226
title
Stage III
description
ISS form multiple myeloma divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Higher stages represent more advanced disease.
param Type
NUMBER
title
International Staging System (ISS)
unit Of Measure
participants

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Preserved source evidence · Not medical advice