NCT00405756 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 169 weeks (Double-blind therapy period plus 4 weeks)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	66 / 150	149 / 150	Not reported / Not reported
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.	62 / 152	151 / 152	Not reported / Not reported
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.	56 / 153	152 / 153	Not reported / Not reported

Group identifiers: EG000: MPR+R · EG001: MPR+p · EG002: MPp+p

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
150
num Events
5
group Id
EG001
num Affected
8
num At Risk
152
num Events
9
group Id
EG002
num Affected
8
num At Risk
153
num Events
8
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
3
num At Risk
152
num Events
3
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
num Events
2
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
3
num At Risk
153
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
2
num At Risk
152
num Events
2
group Id
EG002
num Affected
0
num At Risk
153
num Events
0
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
num Events
2
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
num Events
0
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
num Events
0
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
0
num At Risk
153
num Events
0
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
0
num At Risk
153
num Events
0
term
Septic shock

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
117
num At Risk
150
num Events
951
group Id
EG001
num Affected
116
num At Risk
152
num Events
807
group Id
EG002
num Affected
78
num At Risk
153
num Events
398
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
99
num At Risk
150
num Events
417
group Id
EG001
num Affected
91
num At Risk
152
num Events
351
group Id
EG002
num Affected
82
num At Risk
153
num Events
293
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
103
num At Risk
150
num Events
514
group Id
EG001
num Affected
100
num At Risk
152
num Events
532
group Id
EG002
num Affected
68
num At Risk
153
num Events
268
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
54
num At Risk
150
num Events
418
group Id
EG001
num Affected
58
num At Risk
152
num Events
449
group Id
EG002
num Affected
49
num At Risk
153
num Events
237
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
37
num At Risk
150
num Events
65
group Id
EG001
num Affected
39
num At Risk
152
num Events
66
group Id
EG002
num Affected
51
num At Risk
153
num Events
93
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
49
num At Risk
150
num Events
80
group Id
EG001
num Affected
39
num At Risk
152
num Events
66
group Id
EG002
num Affected
37
num At Risk
153
num Events
57
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
43
num At Risk
150
num Events
124
group Id
EG001
num Affected
36
num At Risk
152
num Events
62
group Id
EG002
num Affected
37
num At Risk
153
num Events
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
15
num At Risk
150
num Events
24
group Id
EG001
num Affected
18
num At Risk
152
num Events
27
group Id
EG002
num Affected
19
num At Risk
153
num Events
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
13
num At Risk
150
num Events
18
group Id
EG001
num Affected
7
num At Risk
152
num Events
9
group Id
EG002
num Affected
13
num At Risk
153
num Events
19
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
16
num At Risk
150
num Events
25
group Id
EG001
num Affected
9
num At Risk
152
num Events
9
group Id
EG002
num Affected
6
num At Risk
153
num Events
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
12
num At Risk
150
num Events
17
group Id
EG001
num Affected
6
num At Risk
152
num Events
6
group Id
EG002
num Affected
8
num At Risk
153
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
12
num At Risk
150
num Events
14
group Id
EG001
num Affected
7
num At Risk
152
num Events
8
group Id
EG002
num Affected
4
num At Risk
153
num Events
6
term
Dry mouth

Complete source fields

event 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
EG000
other Num Affected
149
other Num At Risk
150
serious Num Affected
66
serious Num At Risk
150
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
EG001
other Num Affected
151
other Num At Risk
152
serious Num Affected
62
serious Num At Risk
152
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
EG002
other Num Affected
152
other Num At Risk
153
serious Num Affected
56
serious Num At Risk
153
title
MPp+p

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
117
num At Risk
150
num Events
951
group Id
EG001
num Affected
116
num At Risk
152
num Events
807
group Id
EG002
num Affected
78
num At Risk
153
num Events
398
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
99
num At Risk
150
num Events
417
group Id
EG001
num Affected
91
num At Risk
152
num Events
351
group Id
EG002
num Affected
82
num At Risk
153
num Events
293
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
103
num At Risk
150
num Events
514
group Id
EG001
num Affected
100
num At Risk
152
num Events
532
group Id
EG002
num Affected
68
num At Risk
153
num Events
268
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
54
num At Risk
150
num Events
418
group Id
EG001
num Affected
58
num At Risk
152
num Events
449
group Id
EG002
num Affected
49
num At Risk
153
num Events
237
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
37
num At Risk
150
num Events
65
group Id
EG001
num Affected
39
num At Risk
152
num Events
66
group Id
EG002
num Affected
51
num At Risk
153
num Events
93
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
49
num At Risk
150
num Events
80
group Id
EG001
num Affected
39
num At Risk
152
num Events
66
group Id
EG002
num Affected
37
num At Risk
153
num Events
57
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
43
num At Risk
150
num Events
124
group Id
EG001
num Affected
36
num At Risk
152
num Events
62
group Id
EG002
num Affected
37
num At Risk
153
num Events
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
15
num At Risk
150
num Events
24
group Id
EG001
num Affected
18
num At Risk
152
num Events
27
group Id
EG002
num Affected
19
num At Risk
153
num Events
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
13
num At Risk
150
num Events
18
group Id
EG001
num Affected
7
num At Risk
152
num Events
9
group Id
EG002
num Affected
13
num At Risk
153
num Events
19
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
16
num At Risk
150
num Events
25
group Id
EG001
num Affected
9
num At Risk
152
num Events
9
group Id
EG002
num Affected
6
num At Risk
153
num Events
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
12
num At Risk
150
num Events
17
group Id
EG001
num Affected
6
num At Risk
152
num Events
6
group Id
EG002
num Affected
8
num At Risk
153
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
12
num At Risk
150
num Events
14
group Id
EG001
num Affected
7
num At Risk
152
num Events
8
group Id
EG002
num Affected
4
num At Risk
153
num Events
6
term
Dry mouth

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
150
num Events
5
group Id
EG001
num Affected
8
num At Risk
152
num Events
9
group Id
EG002
num Affected
8
num At Risk
153
num Events
8
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
3
num At Risk
152
num Events
3
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
num Events
2
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
3
num At Risk
153
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
2
num At Risk
152
num Events
2
group Id
EG002
num Affected
0
num At Risk
153
num Events
0
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
num Events
2
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
num Events
0
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
num Events
0
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
0
num At Risk
153
num Events
0
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
0
num At Risk
152
num Events
0
group Id
EG002
num Affected
1
num At Risk
153
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
num Events
1
group Id
EG001
num Affected
1
num At Risk
152
num Events
1
group Id
EG002
num Affected
0
num At Risk
153
num Events
0
term
Septic shock

time Frame

Up to 169 weeks (Double-blind therapy period plus 4 weeks)

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Preserved source evidence · Not medical advice