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Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone (UPFRONT)

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ClinicalTrials.gov Identifier: NCT00507416
Recruitment Status : Completed
First Posted : July 26, 2007
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Thalidomide
Enrollment 502

Recruitment Details Participants took part in the study at 158 investigative sites in the United States from 26 June 2007 to 28 March 2013
Pre-assignment Details Participants with previously untreated multiple myeloma were randomized in a 1:1:1 ratio to one of three treatment groups: VD: Velcade (bortezomib) and dexamethasone; VTD: Velcade, thalidomide, and dexamethasone; VMP: Velcade, melphalan, and prednisone.
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Period Title: Overall Study
Started 168 167 167
Treated (Safety Population) 165 158 163
Completed 8 Treatment Cycles 82 60 69
Completed 50 [1] 42 [1] 53 [1]
Not Completed 118 125 114
Reason Not Completed
Adverse Event             58             67             65
Protocol Violation             1             2             0
Lack ofEfficacy / Physician Decision             7             7             8
Progressive Disease             20             10             13
Patient declined further treatment             18             14             11
Other             11             16             13
Did not Receive Study Treatment             3             9             4
[1]
Completed is defined as having completed 13 treatment cycles.
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone Total
Hide Arm/Group Description Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Total of all reporting groups
Overall Number of Baseline Participants 168 167 167 502
Hide Baseline Analysis Population Description
Intention to treat population, defined as all participants randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 167 participants 167 participants 502 participants
72.6  (9.35) 71.3  (8.73) 71.3  (8.67) 71.7  (8.92)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 167 participants 502 participants
≥ 65 years 140 135 139 414
≥ 75 years 84 64 62 210
≥ 80 years 40 27 23 90
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 167 participants 502 participants
Female
67
  39.9%
97
  58.1%
77
  46.1%
241
  48.0%
Male
101
  60.1%
70
  41.9%
90
  53.9%
261
  52.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 167 participants 502 participants
White 131 124 118 373
Black 23 31 29 83
Native Hawaiian or Other Pacific Islander 0 0 2 2
Asian 2 1 0 3
American Indian or Alaskan Native 0 1 2 3
Other 10 10 15 35
Not Reported 2 0 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 168 participants 167 participants 167 participants 502 participants
168 167 167 502
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description

PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.

Progressive disease requires 1 of the following:

  • Increase of ≥ 25% from nadir in:

    • Serum M-component (absolute increase ≥ 0.5 g/dl)
    • Urine M-component (absolute increase ≥ 200 mg/24 hours)
    • In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
    • Bone marrow plasma cell percentage (absolute % ≥ 10%)
  • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
  • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease
Time Frame From randomization until disease progression. Median follow-up time was 43 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (all randomized participants)
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 168 167 167
Median (95% Confidence Interval)
Unit of Measure: months
14.7
(12.0 to 18.6)
15.4
(12.6 to 24.2)
17.3
(14.8 to 20.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bortezomib and Dexamethasone, Bortezomib, Thalidomide, and Dexamethasone, Bortezomib, Melphalan and Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments The global difference among arms was based on the Wald test.
Method Wald test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With an Overall Response
Hide Description

Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.

CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.

VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).

PR requires 1 of the following:

  • ≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or
  • If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or
  • If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.

If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required.

Time Frame Response assessed every other cycle for up to 13 cycles (49 weeks).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 147 133 145
Measure Type: Number
Unit of Measure: percentage of participants
73 80 70
3.Secondary Outcome
Title Percentage of Participants With a Complete Response
Hide Description Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.
Time Frame Response assessed every other cycle, for up to 13 cycles (49 weeks).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 147 133 145
Measure Type: Number
Unit of Measure: percentage of participants
3 4 4
4.Secondary Outcome
Title Percentage of Participants With a Complete Response or a Very Good Partial Response
Hide Description

Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.

Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.

Response was assessed by the Investigator using the IMWG uniform response criteria.

Time Frame Response assessed every other cycle for up to 13 cycles (49 weeks).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 147 133 145
Measure Type: Number
Unit of Measure: percentage of participants
37 51 41
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.
Time Frame From first documented response until disease progression. Median follow-up time was 43 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an overall response
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 107 106 101
Median (95% Confidence Interval)
Unit of Measure: months
18.3
(14.3 to 24.2)
22.4
(12.7 to 29.1)
19.8
(16.4 to 23.3)
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.
Time Frame From randomization until death. Median follow-up time was 43 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 168 167 167
Median (95% Confidence Interval)
Unit of Measure: months
49.8 [1] 
(35.7 to NA)
51.5 [1] 
(38.5 to NA)
53.1 [1] 
(41.1 to NA)
[1]
Upper limit was not estimable due to low number of events
7.Secondary Outcome
Title Time to Alternative Therapy
Hide Description Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.
Time Frame From randomization until alternative therapy. Median follow-up time was 43 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 168 167 167
Median (95% Confidence Interval)
Unit of Measure: months
19.7
(16.0 to 27.8)
24.5
(16.6 to 27.6)
19.0
(15.2 to 23.1)
8.Secondary Outcome
Title Change From Baseline in EORTC QLQ-C30 - Global Health Status
Hide Description

The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.

Time Frame Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
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Hide Analysis Population Description
Intent-to-treat population with available data at each time point (indicated by "n").
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description:
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Overall Number of Participants Analyzed 168 167 167
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 3, Day 1 (n=129, 115, 125) 1.3  (25.40) -4.4  (27.04) 2.0  (30.82)
Cycle 5, Day 1 (n=114, 98, 107) -4.9  (30.36) -6.1  (27.47) -0.4  (29.24)
Cycle 7, Day 1 (n=89, 79, 84) -3.3  (32.58) -8.6  (31.86) -4.7  (28.61)
Cycle 9, Day 1 (n=87, 66, 67) -4.2  (33.55) -8.1  (28.16) -1.0  (28.55)
Cycle 11, Day 1 (n=71, 61, 65) -11.6  (33.67) -7.9  (29.54) 2.8  (31.72)
Cycle 13, Day 1 (n=67, 52, 61) -10.2  (36.00) -8.5  (32.87) 1.0  (35.16)
Time Frame Adverse events were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 49 weeks.
Adverse Event Reporting Description Per protocol, all grades of peripheral neuropathy and skeletal events, Grade 3/4 AEs, and all SAEs were recorded. There may be grade 1 or 2 events that were not required to be collected.
 
Arm/Group Title Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Hide Arm/Group Description Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance). Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
All-Cause Mortality
Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
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Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   88/165 (53.33%)   92/158 (58.23%)   83/163 (50.92%) 
Blood and lymphatic system disorders       
Anaemia  1  4/165 (2.42%)  6/158 (3.80%)  2/163 (1.23%) 
Haemorrhagic anaemia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Thrombocytopenia  1  1/165 (0.61%)  1/158 (0.63%)  3/163 (1.84%) 
Pancytopenia  1  0/165 (0.00%)  0/158 (0.00%)  3/163 (1.84%) 
Febrile neutropenia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Neutropenia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Coagulopathy  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Cardiac disorders       
Atrial fibrillation  1  7/165 (4.24%)  7/158 (4.43%)  1/163 (0.61%) 
Atrial flutter  1  3/165 (1.82%)  1/158 (0.63%)  1/163 (0.61%) 
Supraventricular tachycardia  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Sinus tachycardia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Cardiac failure congestive  1  7/165 (4.24%)  8/158 (5.06%)  1/163 (0.61%) 
Angina pectoris  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Acute coronary syndrome  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Acute myocardial infarction  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Bradycardia  1  1/165 (0.61%)  2/158 (1.27%)  0/163 (0.00%) 
Arrhythmia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Tachycardia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Cardiac arrest  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Cardio-respiratory arrest  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Ventricular fibrillation  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Pericardial effusion  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Right ventricular failure  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Tricuspid valve incompetence  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Orthostatic hypotension  1  5/165 (3.03%)  1/158 (0.63%)  5/163 (3.07%) 
Gastrointestinal disorders       
Diarrhoea  1  12/165 (7.27%)  5/158 (3.16%)  8/163 (4.91%) 
Vomiting  1  3/165 (1.82%)  5/158 (3.16%)  6/163 (3.68%) 
Nausea  1  2/165 (1.21%)  4/158 (2.53%)  4/163 (2.45%) 
Constipation  1  6/165 (3.64%)  3/158 (1.90%)  3/163 (1.84%) 
Abdominal pain  1  4/165 (2.42%)  3/158 (1.90%)  4/163 (2.45%) 
Gastrointestinal haemorrhage  1  2/165 (1.21%)  4/158 (2.53%)  1/163 (0.61%) 
Ileus  1  1/165 (0.61%)  1/158 (0.63%)  3/163 (1.84%) 
Intestinal obstruction  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Pancreatitis acute  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Pancreatitis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Small intestinal obstruction  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Intestinal perforation  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Large intestinal ulcer  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Large intestine perforation  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Colitis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Colitis ischaemic  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Rectal haemorrhage  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Abdominal hernia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Faecaloma  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Gastric perforation  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Gastritis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Enterocolitis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Abdominal discomfort  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Diverticular perforation  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Intestinal ischaemia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Ileus paralytic  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Stomatitis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
General disorders       
Asthenia  1  6/165 (3.64%)  3/158 (1.90%)  3/163 (1.84%) 
Fatigue  1  1/165 (0.61%)  4/158 (2.53%)  2/163 (1.23%) 
Pyrexia  1  7/165 (4.24%)  2/158 (1.27%)  2/163 (1.23%) 
Pain  1  0/165 (0.00%)  1/158 (0.63%)  2/163 (1.23%) 
Chest pain  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Non-cardiac chest pain  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Oedema peripheral  1  1/165 (0.61%)  2/158 (1.27%)  1/163 (0.61%) 
Generalised oedema  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Death  1  2/165 (1.21%)  1/158 (0.63%)  1/163 (0.61%) 
Multi-organ failure  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Chills  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Nodule  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Cholecystitis acute  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Hepatitis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hepatitis acute  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hyperbilirubinaemia  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Immune system disorders       
Anaphylactic reaction  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Infections and infestations       
Pneumonia  1  18/165 (10.91%)  12/158 (7.59%)  10/163 (6.13%) 
Lobar pneumonia  1  1/165 (0.61%)  2/158 (1.27%)  1/163 (0.61%) 
Bronchitis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Sepsis  1  3/165 (1.82%)  1/158 (0.63%)  2/163 (1.23%) 
Bacteraemia  1  1/165 (0.61%)  1/158 (0.63%)  2/163 (1.23%) 
Septic shock  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Bacterial sepsis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Device related sepsis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Urosepsis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Urinary tract infection  1  2/165 (1.21%)  2/158 (1.27%)  4/163 (2.45%) 
Pyelonephritis acute  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Gastroenteritis  1  1/165 (0.61%)  1/158 (0.63%)  2/163 (1.23%) 
Diverticulitis  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Appendicitis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Peritonitis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Cellulitis  1  3/165 (1.82%)  1/158 (0.63%)  0/163 (0.00%) 
Periorbital cellulitis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Peritonitis bacterial  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Pneumonia bacterial  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Herpes zoster  1  1/165 (0.61%)  0/158 (0.00%)  2/163 (1.23%) 
Herpes zoster disseminated  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Clostridium difficile colitis  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Staphylococcal abscess  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Staphylococcal bacteraemia  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Bursitis infective  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Oesophageal candidiasis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Escherichia urinary tract infection  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Fungal skin infection  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Device related infection  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Pneumonia pneumococcal  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Viral infection  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Duodenal perforation  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Injury, poisoning and procedural complications       
Spinal compression fracture  1  3/165 (1.82%)  5/158 (3.16%)  1/163 (0.61%) 
Ankle fracture  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hip fracture  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Lower limb fracture  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Brain contusion  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Extradural haematoma  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Fall  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Fractured ischium  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Pelvic fracture  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Pubis fracture  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Laceration  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Coronary artery restenosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Drug dispensing error  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Tendon rupture  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Rib fracture  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Humerus fracture  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Investigations       
International normalised ratio increased  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Prothrombin time prolonged  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Alanine aminotransferase increased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Aspartate aminotransferase increased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hepatic enzyme increased  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Blood creatinine increased  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Klebsiella test positive  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Blood culture positive  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Blood potassium decreased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Haemoglobin decreased  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Troponin I increased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
White blood cell count decreased  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Metabolism and nutrition disorders       
Dehydration  1  8/165 (4.85%)  6/158 (3.80%)  9/163 (5.52%) 
Hypovolaemia  1  2/165 (1.21%)  1/158 (0.63%)  0/163 (0.00%) 
Hyponatraemia  1  3/165 (1.82%)  1/158 (0.63%)  4/163 (2.45%) 
Hypokalaemia  1  2/165 (1.21%)  3/158 (1.90%)  1/163 (0.61%) 
Hyperkalaemia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hyperglycaemia  1  2/165 (1.21%)  2/158 (1.27%)  0/163 (0.00%) 
Hypoglycaemia  1  2/165 (1.21%)  1/158 (0.63%)  1/163 (0.61%) 
Hypercalcaemia  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Hypocalcaemia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Decreased appetite  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Cachexia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Failure to thrive  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Diabetes mellitus inadequate control  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Electrolyte imbalance  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Lactic acidosis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Fluid overload  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  3/165 (1.82%)  3/158 (1.90%)  5/163 (3.07%) 
Pain in extremity  1  2/165 (1.21%)  2/158 (1.27%)  2/163 (1.23%) 
Musculoskeletal chest pain  1  0/165 (0.00%)  0/158 (0.00%)  2/163 (1.23%) 
Musculoskeletal pain  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Neck pain  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Muscular weakness  1  2/165 (1.21%)  3/158 (1.90%)  3/163 (1.84%) 
Arthralgia  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Cervical spinal stenosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Lumbar spinal stenosis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Bone pain  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Costochondritis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Intervertebral disc compression  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Osteolysis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Multiple myeloma  1  1/165 (0.61%)  2/158 (1.27%)  1/163 (0.61%) 
Plasmacytoma  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Cancer pain  1  0/165 (0.00%)  2/158 (1.27%)  1/163 (0.61%) 
Metastases to liver  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Metastases to lung  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Nervous system disorders       
Neuropathy peripheral  1  2/165 (1.21%)  5/158 (3.16%)  4/163 (2.45%) 
Peripheral sensory neuropathy  1  3/165 (1.82%)  3/158 (1.90%)  0/163 (0.00%) 
Peripheral motor neuropathy  1  2/165 (1.21%)  1/158 (0.63%)  0/163 (0.00%) 
Neuralgic amyotrophy  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Syncope  1  5/165 (3.03%)  5/158 (3.16%)  5/163 (3.07%) 
Lethargy  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Cerebrovascular accident  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Haemorrhage intracranial  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Spinal haematoma  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Encephalopathy  1  1/165 (0.61%)  2/158 (1.27%)  0/163 (0.00%) 
Dizziness  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Dizziness postural  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Dementia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Dementia with Lewy bodies  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hepatic encephalopathy  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Metabolic encephalopathy  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hypoaesthesia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Neuralgia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
VIth nerve paralysis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Sciatica  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Cognitive disorder  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Quadriplegia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Convulsion  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Spinal cord compression  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Psychiatric disorders       
Confusional state  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Depression  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Mental status changes  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Panic attack  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Acute psychosis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Withdrawal syndrome  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Renal and urinary disorders       
Renal failure  1  2/165 (1.21%)  1/158 (0.63%)  3/163 (1.84%) 
Renal failure acute  1  1/165 (0.61%)  2/158 (1.27%)  2/163 (1.23%) 
Renal impairment  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Urinary retention  1  2/165 (1.21%)  0/158 (0.00%)  1/163 (0.61%) 
Nephrolithiasis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Hydronephrosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Renal tubular necrosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Haematuria  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  4/165 (2.42%)  4/158 (2.53%)  2/163 (1.23%) 
Pulmonary embolism  1  5/165 (3.03%)  4/158 (2.53%)  1/163 (0.61%) 
Chronic obstructive pulmonary disease  1  2/165 (1.21%)  1/158 (0.63%)  0/163 (0.00%) 
Asthma  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Respiratory failure  1  1/165 (0.61%)  2/158 (1.27%)  0/163 (0.00%) 
Acute respiratory failure  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Pneumonitis  1  2/165 (1.21%)  0/158 (0.00%)  1/163 (0.61%) 
Pneumonia aspiration  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Pulmonary hypertension  1  0/165 (0.00%)  3/158 (1.90%)  0/163 (0.00%) 
Hypoxia  1  2/165 (1.21%)  0/158 (0.00%)  0/163 (0.00%) 
Lung infiltration  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Pleural effusion  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Pneumothorax  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Pleuritic pain  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Vascular disorders       
Hypotension  1  3/165 (1.82%)  3/158 (1.90%)  6/163 (3.68%) 
Deep vein thrombosis  1  7/165 (4.24%)  4/158 (2.53%)  2/163 (1.23%) 
Jugular vein thrombosis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Peripheral embolism  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Shock haemorrhagic  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Phlebitis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortezomib and Dexamethasone Bortezomib, Thalidomide, and Dexamethasone Bortezomib, Melphalan and Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   57/165 (34.55%)   68/158 (43.04%)   68/163 (41.72%) 
Blood and lymphatic system disorders       
Leukopenia  1  2/165 (1.21%)  1/158 (0.63%)  12/163 (7.36%) 
Lymphopenia  1  0/165 (0.00%)  2/158 (1.27%)  4/163 (2.45%) 
Leukocytosis  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Lymphadenopathy  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Cardiac disorders       
Pericarditis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Restrictive cardiomyopathy  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Sick sinus syndrome  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Sinus bradycardia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Ventricular extrasystoles  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Ventricular tachycardia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Ear and labyrinth disorders       
Hypoacusis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Cushingoid  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Inappropriate antidiuretic hormone secretion  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Eye disorders       
Vision blurred  1  3/165 (1.82%)  5/158 (3.16%)  1/163 (0.61%) 
Conjunctivitis  1  1/165 (0.61%)  2/158 (1.27%)  1/163 (0.61%) 
Eye swelling  1  2/165 (1.21%)  0/158 (0.00%)  0/163 (0.00%) 
Visual impairment  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Blepharitis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Conjunctivitis allergic  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Diplopia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Eye haemorrhage  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Eye pruritus  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Lacrimation increased  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Ocular hyperaemia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Gastrointestinal disorders       
Dyspepsia  1  3/165 (1.82%)  3/158 (1.90%)  0/163 (0.00%) 
Abdominal pain upper  1  1/165 (0.61%)  2/158 (1.27%)  1/163 (0.61%) 
Abdominal distension  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Dry mouth  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Gastrooesophageal reflux disease  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Ascites  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Flatulence  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Hiatus hernia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Toothache  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
General disorders       
Gait disturbance  1  0/165 (0.00%)  1/158 (0.63%)  2/163 (1.23%) 
Catheter site erythema  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Drug withdrawal syndrome  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Face oedema  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Feeling jittery  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Influenza like illness  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Irritability  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Malaise  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Oedema  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Soft tissue inflammation  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Immune system disorders       
Seasonal allergy  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Infections and infestations       
Oral candidiasis  1  1/165 (0.61%)  0/158 (0.00%)  4/163 (2.45%) 
Upper respiratory tract infection  1  2/165 (1.21%)  1/158 (0.63%)  2/163 (1.23%) 
Conjunctivitis bacterial  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Hordeolum  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Oral fungal infection  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Sinusitis  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Bronchopulmonary aspergillosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Cystitis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Folliculitis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Furuncle  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Gastroenteritis viral  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Herpes zoster ophthalmic  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Localised infection  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Nasopharyngitis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Pneumococcal sepsis  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Skin bacterial infection  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Subcutaneous abscess  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Injury, poisoning and procedural complications       
Avulsion fracture  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Contusion  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Excoriation  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Facial bones fracture  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Foot fracture  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Jaw fracture  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Lumbar vertebral fracture  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Thoracic vertebral fracture  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Investigations       
Weight decreased  1  4/165 (2.42%)  2/158 (1.27%)  6/163 (3.68%) 
Platelet count decreased  1  3/165 (1.82%)  1/158 (0.63%)  7/163 (4.29%) 
Blood sodium decreased  1  3/165 (1.82%)  3/158 (1.90%)  3/163 (1.84%) 
Blood uric acid increased  1  2/165 (1.21%)  3/158 (1.90%)  3/163 (1.84%) 
Neutrophil count decreased  1  0/165 (0.00%)  0/158 (0.00%)  6/163 (3.68%) 
Blood alkaline phosphatase increased  1  0/165 (0.00%)  0/158 (0.00%)  3/163 (1.84%) 
Blood urea increased  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Protein total increased  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Weight increased  1  0/165 (0.00%)  3/158 (1.90%)  0/163 (0.00%) 
Blood bilirubin increased  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Troponin T increased  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Blood calcium increased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Blood chloride decreased  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Blood creatinine decreased  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Blood glucose increased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Blood immunoglobulin G increased  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Blood phosphorus decreased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Blood potassium increased  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Breath sounds abnormal  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Carbon monoxide diffusing capacity decreased  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Lymphocyte count decreased  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Lymphocyte count increased  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Red blood cell count decreased  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Metabolism and nutrition disorders       
Hyperuricaemia  1  3/165 (1.82%)  8/158 (5.06%)  4/163 (2.45%) 
Hypomagnesaemia  1  0/165 (0.00%)  1/158 (0.63%)  2/163 (1.23%) 
Diabetes mellitus  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Hypophosphataemia  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Gout  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Hyperlipidaemia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Hypoalbuminaemia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Vitamin B12 deficiency  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms  1  1/165 (0.61%)  2/158 (1.27%)  1/163 (0.61%) 
Myalgia  1  3/165 (1.82%)  0/158 (0.00%)  0/163 (0.00%) 
Groin pain  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Flank pain  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Joint swelling  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Muscle tightness  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Musculoskeletal stiffness  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Neck mass  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Osteonecrosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Pain in jaw  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Pathological fracture  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Rotator cuff syndrome  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour pain  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Nervous system disorders       
Dysgeusia  1  2/165 (1.21%)  4/158 (2.53%)  2/163 (1.23%) 
Post herpetic neuralgia  1  2/165 (1.21%)  2/158 (1.27%)  1/163 (0.61%) 
Tremor  1  2/165 (1.21%)  2/158 (1.27%)  1/163 (0.61%) 
Balance disorder  1  2/165 (1.21%)  2/158 (1.27%)  0/163 (0.00%) 
Paraesthesia  1  1/165 (0.61%)  0/158 (0.00%)  3/163 (1.84%) 
Headache  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Peripheral sensorimotor neuropathy  1  0/165 (0.00%)  1/158 (0.63%)  2/163 (1.23%) 
Somnolence  1  1/165 (0.61%)  2/158 (1.27%)  0/163 (0.00%) 
Ageusia  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Cranial nerve disorder  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Dysarthria  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Memory impairment  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Ataxia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Hemiparesis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Hypogeusia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Polyneuropathy  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Presyncope  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Psychiatric disorders       
Insomnia  1  9/165 (5.45%)  6/158 (3.80%)  6/163 (3.68%) 
Anxiety  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Mood altered  1  2/165 (1.21%)  1/158 (0.63%)  0/163 (0.00%) 
Disorientation  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Mood swings  1  2/165 (1.21%)  0/158 (0.00%)  0/163 (0.00%) 
Agitation  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Anhedonia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Anxiety disorder due to a general medical condition  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Delusion  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Depressed mood  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Dysphoria  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Psychotic disorder  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Restlessness  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Renal and urinary disorders       
Dysuria  1  2/165 (1.21%)  0/158 (0.00%)  3/163 (1.84%) 
Pollakiuria  1  0/165 (0.00%)  1/158 (0.63%)  2/163 (1.23%) 
Urinary incontinence  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Azotaemia  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Nocturia  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Reproductive system and breast disorders       
Pelvic pain  1  2/165 (1.21%)  0/158 (0.00%)  0/163 (0.00%) 
Erectile dysfunction  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Vaginal haemorrhage  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/165 (1.82%)  5/158 (3.16%)  3/163 (1.84%) 
Oropharyngeal pain  1  2/165 (1.21%)  2/158 (1.27%)  1/163 (0.61%) 
Dysphonia  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Epistaxis  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Nasal congestion  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Productive cough  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Sinus congestion  1  1/165 (0.61%)  1/158 (0.63%)  0/163 (0.00%) 
Atelectasis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Dyspnoea exertional  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Rales  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Respiratory tract congestion  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Sleep apnoea syndrome  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Wheezing  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash pruritic  1  0/165 (0.00%)  5/158 (3.16%)  3/163 (1.84%) 
Pruritus  1  1/165 (0.61%)  1/158 (0.63%)  4/163 (2.45%) 
Decubitus ulcer  1  1/165 (0.61%)  1/158 (0.63%)  1/163 (0.61%) 
Rash erythematous  1  0/165 (0.00%)  1/158 (0.63%)  2/163 (1.23%) 
Dermatitis  1  0/165 (0.00%)  0/158 (0.00%)  2/163 (1.23%) 
Drug eruption  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Dry skin  1  0/165 (0.00%)  2/158 (1.27%)  0/163 (0.00%) 
Rash macular  1  0/165 (0.00%)  1/158 (0.63%)  1/163 (0.61%) 
Acne  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Alopecia  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Dermatitis allergic  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Dermatitis bullous  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Dermatitis exfoliative  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Diabetic foot  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Ecchymosis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Erythema  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Exfoliative rash  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Heat rash  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Lichenoid keratosis  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Petechiae  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Rash  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Rash maculo-papular  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Rash vesicular  1  0/165 (0.00%)  0/158 (0.00%)  1/163 (0.61%) 
Skin lesion  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Skin ulcer  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Swelling face  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Urticaria  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Vascular disorders       
Hypertension  1  0/165 (0.00%)  3/158 (1.90%)  2/163 (1.23%) 
Hot flush  1  1/165 (0.61%)  0/158 (0.00%)  1/163 (0.61%) 
Haematoma  1  1/165 (0.61%)  0/158 (0.00%)  0/163 (0.00%) 
Thrombophlebitis superficial  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Thrombosis  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Withdrawal hypertension  1  0/165 (0.00%)  1/158 (0.63%)  0/163 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Millennium Pharmaceuticals Inc
Phone: 1-800-778-2860
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00507416     History of Changes
Other Study ID Numbers: C05009
First Submitted: July 25, 2007
First Posted: July 26, 2007
Results First Submitted: March 28, 2014
Results First Posted: May 1, 2014
Last Update Posted: May 1, 2014