NCT01345019 · BASELINE

Baseline characteristics

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma · Source last updated 2022-11-08

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

denoms

counts
group Id
BG000
value
859
group Id
BG001
value
859
group Id
BG002
value
1718
units
Participants

groups

description
Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
id
BG000
title
Zoledronic Acid
description
Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
id
BG001
title
Denosumab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
10.5
value
63.3
group Id
BG001
spread
10.6
value
63.5
group Id
BG002
spread
10.6
value
63.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
464
group Id
BG001
value
472
group Id
BG002
value
936
title
< 65 years
measurements
group Id
BG000
value
395
group Id
BG001
value
387
group Id
BG002
value
782
title
≥ 65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
386
group Id
BG001
value
397
group Id
BG002
value
783
title
Female
measurements
group Id
BG000
value
473
group Id
BG001
value
462
group Id
BG002
value
935
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
35
group Id
BG002
value
70
title
Hispanic or Latino
measurements
group Id
BG000
value
819
group Id
BG001
value
823
group Id
BG002
value
1642
title
Not Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
699
group Id
BG001
value
711
group Id
BG002
value
1410
title
White
measurements
group Id
BG000
value
101
group Id
BG001
value
107
group Id
BG002
value
208
title
Asian
measurements
group Id
BG000
value
36
group Id
BG001
value
29
group Id
BG002
value
65
title
Black or African American
measurements
group Id
BG000
value
19
group Id
BG001
value
10
group Id
BG002
value
29
title
Other
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Multiracial
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
259
group Id
BG001
value
263
group Id
BG002
value
522
title
0 (Fully active)
measurements
group Id
BG000
value
413
group Id
BG001
value
400
group Id
BG002
value
813
title
1 (Restricted but ambulatory)
measurements
group Id
BG000
value
187
group Id
BG001
value
196
group Id
BG002
value
383
title
2 (Ambulatory but unable to work)
description
A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
577
group Id
BG001
value
567
group Id
BG002
value
1144
title
Any Skeletal Related Event
categories
measurements
group Id
BG000
value
463
group Id
BG001
value
479
group Id
BG002
value
942
title
Pathological fracture
categories
measurements
group Id
BG000
value
115
group Id
BG001
value
92
group Id
BG002
value
207
title
Spinal cord compression
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
118
group Id
BG002
value
257
title
Radiation therapy to bone
categories
measurements
group Id
BG000
value
144
group Id
BG001
value
142
group Id
BG002
value
286
title
Surgery to bone
param Type
NUMBER
title
Skeletal Related Event History
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
465
group Id
BG001
value
465
group Id
BG002
value
930
title
Intent to undergo PBSC transplantation: Yes
categories
measurements
group Id
BG000
value
394
group Id
BG001
value
394
group Id
BG002
value
788
title
Intent to undergo PBSC transplantation: No
categories
measurements
group Id
BG000
value
821
group Id
BG001
value
819
group Id
BG002
value
1640
title
Anti-myeloma agent utilized/planned: Novel
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
40
group Id
BG002
value
78
title
Anti-myeloma agent utilized/planned: Non-novel
categories
measurements
group Id
BG000
value
268
group Id
BG001
value
263
group Id
BG002
value
531
title
ISS stage at diagnosis: I
categories
measurements
group Id
BG000
value
313
group Id
BG001
value
319
group Id
BG002
value
632
title
ISS stage at diagnosis: II
categories
measurements
group Id
BG000
value
278
group Id
BG001
value
277
group Id
BG002
value
555
title
ISS stage at diagnosis: III
categories
measurements
group Id
BG000
value
484
group Id
BG001
value
481
group Id
BG002
value
965
title
Previous SRE : Yes
categories
measurements
group Id
BG000
value
375
group Id
BG001
value
378
group Id
BG002
value
753
title
Previous SRE : No
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
24
group Id
BG002
value
42
title
Region: Japan
categories
measurements
group Id
BG000
value
841
group Id
BG001
value
835
group Id
BG002
value
1676
title
Region: Non-Japan
description
Randomization was stratified by * Intent to undergo autologous peripheral blood stem cell (PBSC) transplantation: yes or no * The anti-myeloma agent being utilized/planned to be utilized in first-line therapy: novel therapy (included bortezomib, lenalidomide, or thalidomide) based or non-novel therapy-based, * International Staging System (ISS) stage at diagnosis: I (serum β2 microglobulin \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL) or II (neither stage I or III) or III (serum β2 microglobulin ≥ 5.5 mg/L), * Previous skeletal-related event (SRE): yes or no, * Region (Japan, non-Japan).
param Type
NUMBER
title
Summary of Randomization Stratifications
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
859
group Id
BG001
value
859
group Id
BG002
value
1718
units
Participants

groups

description
Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
id
BG000
title
Zoledronic Acid
description
Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
id
BG001
title
Denosumab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
10.5
value
63.3
group Id
BG001
spread
10.6
value
63.5
group Id
BG002
spread
10.6
value
63.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
464
group Id
BG001
value
472
group Id
BG002
value
936
title
< 65 years
measurements
group Id
BG000
value
395
group Id
BG001
value
387
group Id
BG002
value
782
title
≥ 65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
386
group Id
BG001
value
397
group Id
BG002
value
783
title
Female
measurements
group Id
BG000
value
473
group Id
BG001
value
462
group Id
BG002
value
935
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
35
group Id
BG002
value
70
title
Hispanic or Latino
measurements
group Id
BG000
value
819
group Id
BG001
value
823
group Id
BG002
value
1642
title
Not Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
699
group Id
BG001
value
711
group Id
BG002
value
1410
title
White
measurements
group Id
BG000
value
101
group Id
BG001
value
107
group Id
BG002
value
208
title
Asian
measurements
group Id
BG000
value
36
group Id
BG001
value
29
group Id
BG002
value
65
title
Black or African American
measurements
group Id
BG000
value
19
group Id
BG001
value
10
group Id
BG002
value
29
title
Other
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Multiracial
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
259
group Id
BG001
value
263
group Id
BG002
value
522
title
0 (Fully active)
measurements
group Id
BG000
value
413
group Id
BG001
value
400
group Id
BG002
value
813
title
1 (Restricted but ambulatory)
measurements
group Id
BG000
value
187
group Id
BG001
value
196
group Id
BG002
value
383
title
2 (Ambulatory but unable to work)
description
A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
577
group Id
BG001
value
567
group Id
BG002
value
1144
title
Any Skeletal Related Event
categories
measurements
group Id
BG000
value
463
group Id
BG001
value
479
group Id
BG002
value
942
title
Pathological fracture
categories
measurements
group Id
BG000
value
115
group Id
BG001
value
92
group Id
BG002
value
207
title
Spinal cord compression
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
118
group Id
BG002
value
257
title
Radiation therapy to bone
categories
measurements
group Id
BG000
value
144
group Id
BG001
value
142
group Id
BG002
value
286
title
Surgery to bone
param Type
NUMBER
title
Skeletal Related Event History
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
465
group Id
BG001
value
465
group Id
BG002
value
930
title
Intent to undergo PBSC transplantation: Yes
categories
measurements
group Id
BG000
value
394
group Id
BG001
value
394
group Id
BG002
value
788
title
Intent to undergo PBSC transplantation: No
categories
measurements
group Id
BG000
value
821
group Id
BG001
value
819
group Id
BG002
value
1640
title
Anti-myeloma agent utilized/planned: Novel
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
40
group Id
BG002
value
78
title
Anti-myeloma agent utilized/planned: Non-novel
categories
measurements
group Id
BG000
value
268
group Id
BG001
value
263
group Id
BG002
value
531
title
ISS stage at diagnosis: I
categories
measurements
group Id
BG000
value
313
group Id
BG001
value
319
group Id
BG002
value
632
title
ISS stage at diagnosis: II
categories
measurements
group Id
BG000
value
278
group Id
BG001
value
277
group Id
BG002
value
555
title
ISS stage at diagnosis: III
categories
measurements
group Id
BG000
value
484
group Id
BG001
value
481
group Id
BG002
value
965
title
Previous SRE : Yes
categories
measurements
group Id
BG000
value
375
group Id
BG001
value
378
group Id
BG002
value
753
title
Previous SRE : No
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
24
group Id
BG002
value
42
title
Region: Japan
categories
measurements
group Id
BG000
value
841
group Id
BG001
value
835
group Id
BG002
value
1676
title
Region: Non-Japan
description
Randomization was stratified by * Intent to undergo autologous peripheral blood stem cell (PBSC) transplantation: yes or no * The anti-myeloma agent being utilized/planned to be utilized in first-line therapy: novel therapy (included bortezomib, lenalidomide, or thalidomide) based or non-novel therapy-based, * International Staging System (ISS) stage at diagnosis: I (serum β2 microglobulin \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL) or II (neither stage I or III) or III (serum β2 microglobulin ≥ 5.5 mg/L), * Previous skeletal-related event (SRE): yes or no, * Region (Japan, non-Japan).
param Type
NUMBER
title
Summary of Randomization Stratifications
unit Of Measure
participants

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

Preserved source evidence · Not medical advice