Number of Participants With Shifts From Baseline to Worst Value in Eastern Cooperative Oncology Group (ECOG) Performance Score
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 9 years
What was measured
Eastern Cooperative Oncology Group (ECOG) scale score ranged from 0 to 5, where 0 indicated normal activity and 5 indicated death. The data is reported for those categories where at least 1 participant had worst post-baseline value for each ECOG score.
Analysis population: Safety population is defined as all participants who receive at least 1 dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis.
Groups in this outcome
Placebo + LenDex
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
Ixazomib + LenDex
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
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
Placebo + LenDex
344
Ixazomib + LenDex
340
Reported measurements
Baseline Score 0, Post-Baseline Score 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
23
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
23
Not reported
Not reported
Not reported
Not reported
Baseline Score 0, Post-Baseline Score 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
57
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
52
Not reported
Not reported
Not reported
Not reported
Baseline Score 0, Post-Baseline Score 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
20
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
23
Not reported
Not reported
Not reported
Not reported
Baseline Score 0, Post-Baseline Score 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
2
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
10
Not reported
Not reported
Not reported
Not reported
Baseline Score 1, Post-Baseline Score 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
1
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
1
Not reported
Not reported
Not reported
Not reported
Baseline Score 1, Post-Baseline Score 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
96
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
104
Not reported
Not reported
Not reported
Not reported
Baseline Score 1, Post-Baseline Score 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
72
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
57
Not reported
Not reported
Not reported
Not reported
Baseline Score 1, Post-Baseline Score 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
18
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
9
Not reported
Not reported
Not reported
Not reported
Baseline Score 1, Post-Baseline Score 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
6
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
4
Not reported
Not reported
Not reported
Not reported
Baseline Score 2, Post-Baseline Score 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
12
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
8
Not reported
Not reported
Not reported
Not reported
Baseline Score 2, Post-Baseline Score 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
28
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
35
Not reported
Not reported
Not reported
Not reported
Baseline Score 2, Post-Baseline Score 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
7
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
11
Not reported
Not reported
Not reported
Not reported
Baseline Score 2, Post-Baseline Score 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex
2
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
23
title
Baseline Score 0, Post-Baseline Score 0
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
52
title
Baseline Score 0, Post-Baseline Score 1
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
23
title
Baseline Score 0, Post-Baseline Score 2
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
10
title
Baseline Score 0, Post-Baseline Score 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Baseline Score 1, Post-Baseline Score 0
categories
measurements
group Id
OG000
value
96
group Id
OG001
value
104
title
Baseline Score 1, Post-Baseline Score 1
categories
measurements
group Id
OG000
value
72
group Id
OG001
value
57
title
Baseline Score 1, Post-Baseline Score 2
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
9
title
Baseline Score 1, Post-Baseline Score 3
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
title
Baseline Score 1, Post-Baseline Score 4
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
8
title
Baseline Score 2, Post-Baseline Score 1
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
35
title
Baseline Score 2, Post-Baseline Score 2
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
11
title
Baseline Score 2, Post-Baseline Score 3
denoms
counts
group Id
OG000
value
344
group Id
OG001
value
340
units
Participants
description
Eastern Cooperative Oncology Group (ECOG) scale score ranged from 0 to 5, where 0 indicated normal activity and 5 indicated death. The data is reported for those categories where at least 1 participant had worst post-baseline value for each ECOG score.
groups
description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
OG000
title
Placebo + LenDex
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
OG001
title
Ixazomib + LenDex
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population is defined as all participants who receive at least 1 dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis.
reporting Status
POSTED
time Frame
Up to approximately 9 years
title
Number of Participants With Shifts From Baseline to Worst Value in Eastern Cooperative Oncology Group (ECOG) Performance Score
Triangle