Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period
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.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 169 weeks (Double-blind therapy period plus 4 weeks)
What was measured
Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.
Analysis population: Safety population
Groups in this outcome
MPR+R
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.
MPR+p
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.
MPp+p
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.
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
MPR+R
150
MPR+p
152
MPp+p
153
Reported measurements
>=1 adverse event (AE)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
150
Not reported
Not reported
Not reported
Not reported
MPR+p
151
Not reported
Not reported
Not reported
Not reported
MPp+p
153
Not reported
Not reported
Not reported
Not reported
>=1 CTCAE grade 3-4 AE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
137
Not reported
Not reported
Not reported
Not reported
MPR+p
129
Not reported
Not reported
Not reported
Not reported
MPp+p
107
Not reported
Not reported
Not reported
Not reported
>=1 CTCAE grade 5 AE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
7
Not reported
Not reported
Not reported
Not reported
MPR+p
6
Not reported
Not reported
Not reported
Not reported
MPp+p
7
Not reported
Not reported
Not reported
Not reported
>=1 serious AE (SAE)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
66
Not reported
Not reported
Not reported
Not reported
MPR+p
62
Not reported
Not reported
Not reported
Not reported
MPp+p
56
Not reported
Not reported
Not reported
Not reported
>=1 AE related to Lenaldomide/Placebo
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
148
Not reported
Not reported
Not reported
Not reported
MPR+p
145
Not reported
Not reported
Not reported
Not reported
MPp+p
131
Not reported
Not reported
Not reported
Not reported
>=1 AE related to Melphalan
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
140
Not reported
Not reported
Not reported
Not reported
MPR+p
134
Not reported
Not reported
Not reported
Not reported
MPp+p
126
Not reported
Not reported
Not reported
Not reported
>=1AE related to Prednisone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
87
Not reported
Not reported
Not reported
Not reported
MPR+p
94
Not reported
Not reported
Not reported
Not reported
MPp+p
93
Not reported
Not reported
Not reported
Not reported
>=1 Grade 3-4 AE related to Lenaldomide/Placebo
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
128
Not reported
Not reported
Not reported
Not reported
MPR+p
117
Not reported
Not reported
Not reported
Not reported
MPp+p
68
Not reported
Not reported
Not reported
Not reported
>=1 Grade 3-4 AE related to Melphalan
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
118
Not reported
Not reported
Not reported
Not reported
MPR+p
110
Not reported
Not reported
Not reported
Not reported
MPp+p
62
Not reported
Not reported
Not reported
Not reported
>=1 Grade 3-4 AE related to Prednisone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
32
Not reported
Not reported
Not reported
Not reported
MPR+p
29
Not reported
Not reported
Not reported
Not reported
MPp+p
22
Not reported
Not reported
Not reported
Not reported
>=1 Grade 5 AE related to Lenalidomide/Placebo
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
3
Not reported
Not reported
Not reported
Not reported
MPR+p
2
Not reported
Not reported
Not reported
Not reported
MPp+p
2
Not reported
Not reported
Not reported
Not reported
>=1 Grade 5 AE related to Melphalan
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
3
Not reported
Not reported
Not reported
Not reported
MPR+p
1
Not reported
Not reported
Not reported
Not reported
MPp+p
3
Not reported
Not reported
Not reported
Not reported
>=1 Grade 5 AE related to Prednisone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
1
Not reported
Not reported
Not reported
Not reported
MPR+p
1
Not reported
Not reported
Not reported
Not reported
MPp+p
1
Not reported
Not reported
Not reported
Not reported
>=1 SAE related to Lenalidomide/Placebo
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
38
Not reported
Not reported
Not reported
Not reported
MPR+p
32
Not reported
Not reported
Not reported
Not reported
MPp+p
11
Not reported
Not reported
Not reported
Not reported
>=1 SAE related to Melphalan
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
27
Not reported
Not reported
Not reported
Not reported
MPR+p
24
Not reported
Not reported
Not reported
Not reported
MPp+p
11
Not reported
Not reported
Not reported
Not reported
>=1 SAE related to Prednisone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
19
Not reported
Not reported
Not reported
Not reported
MPR+p
16
Not reported
Not reported
Not reported
Not reported
MPp+p
5
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Lenalidomide/Placebo withdrawal
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
26
Not reported
Not reported
Not reported
Not reported
MPR+p
24
Not reported
Not reported
Not reported
Not reported
MPp+p
14
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Melphalan withdrawal
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
20
Not reported
Not reported
Not reported
Not reported
MPR+p
19
Not reported
Not reported
Not reported
Not reported
MPp+p
10
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Prednisone withdrawal
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
20
Not reported
Not reported
Not reported
Not reported
MPR+p
19
Not reported
Not reported
Not reported
Not reported
MPp+p
10
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Lenalidomide/Plac dose reduction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
71
Not reported
Not reported
Not reported
Not reported
MPR+p
70
Not reported
Not reported
Not reported
Not reported
MPp+p
26
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Melphalan dose reduction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
47
Not reported
Not reported
Not reported
Not reported
MPR+p
58
Not reported
Not reported
Not reported
Not reported
MPp+p
21
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Prednisone dose reduction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
15
Not reported
Not reported
Not reported
Not reported
MPR+p
7
Not reported
Not reported
Not reported
Not reported
MPp+p
5
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Lenalidomide/Plac dose interrupt
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
92
Not reported
Not reported
Not reported
Not reported
MPR+p
82
Not reported
Not reported
Not reported
Not reported
MPp+p
51
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Melphalan dose interruption
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
5
Not reported
Not reported
Not reported
Not reported
MPR+p
1
Not reported
Not reported
Not reported
Not reported
MPp+p
0
Not reported
Not reported
Not reported
Not reported
>=1 AE leading to Prednisone dose interruption
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MPR+R
28
Not reported
Not reported
Not reported
Not reported
MPR+p
39
Not reported
Not reported
Not reported
Not reported
MPp+p
15
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
150
group Id
OG001
value
151
group Id
OG002
value
153
title
>=1 adverse event (AE)
categories
measurements
group Id
OG000
value
137
group Id
OG001
value
129
group Id
OG002
value
107
title
>=1 CTCAE grade 3-4 AE
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
6
group Id
OG002
value
7
title
>=1 CTCAE grade 5 AE
categories
measurements
group Id
OG000
value
66
group Id
OG001
value
62
group Id
OG002
value
56
title
>=1 serious AE (SAE)
categories
measurements
group Id
OG000
value
148
group Id
OG001
value
145
group Id
OG002
value
131
title
>=1 AE related to Lenaldomide/Placebo
categories
measurements
group Id
OG000
value
140
group Id
OG001
value
134
group Id
OG002
value
126
title
>=1 AE related to Melphalan
categories
measurements
group Id
OG000
value
87
group Id
OG001
value
94
group Id
OG002
value
93
title
>=1AE related to Prednisone
categories
measurements
group Id
OG000
value
128
group Id
OG001
value
117
group Id
OG002
value
68
title
>=1 Grade 3-4 AE related to Lenaldomide/Placebo
categories
measurements
group Id
OG000
value
118
group Id
OG001
value
110
group Id
OG002
value
62
title
>=1 Grade 3-4 AE related to Melphalan
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
29
group Id
OG002
value
22
title
>=1 Grade 3-4 AE related to Prednisone
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
title
>=1 Grade 5 AE related to Lenalidomide/Placebo
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
3
title
>=1 Grade 5 AE related to Melphalan
denoms
counts
group Id
OG000
value
150
group Id
OG001
value
152
group Id
OG002
value
153
units
Participants
description
Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.
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
OG000
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
OG001
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
OG002
title
MPp+p
param Type
NUMBER
population Description
Safety population
reporting Status
POSTED
time Frame
Up to 169 weeks (Double-blind therapy period plus 4 weeks)
title
Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period
Triangle