Trial Outcomes & Findings for A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma (NCT NCT00872521)
NCT ID: NCT00872521
Last Updated: 2014-05-16
Results Overview
International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
84 days
Results posted on
2014-05-16
Participant Flow
The participants were enrolled at multiple sites in Australia
107 participants were enrolled and they all received the study treatment.
Participant milestones
| Measure |
1q21 Amplified
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Not Amplified
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|
|
Completed PAD Induction
STARTED
|
26
|
72
|
9
|
|
Completed PAD Induction
COMPLETED
|
21
|
68
|
9
|
|
Completed PAD Induction
NOT COMPLETED
|
5
|
4
|
0
|
|
Primary Endpoint Analysis
STARTED
|
21
|
68
|
9
|
|
Primary Endpoint Analysis
COMPLETED
|
20
|
63
|
8
|
|
Primary Endpoint Analysis
NOT COMPLETED
|
1
|
5
|
1
|
|
Completed 3-month Follow up
STARTED
|
20
|
63
|
8
|
|
Completed 3-month Follow up
COMPLETED
|
20
|
60
|
8
|
|
Completed 3-month Follow up
NOT COMPLETED
|
0
|
3
|
0
|
|
Secondary Endpoint Analysis
STARTED
|
20
|
60
|
8
|
|
Secondary Endpoint Analysis
COMPLETED
|
20
|
58
|
7
|
|
Secondary Endpoint Analysis
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
1q21 Amplified
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Not Amplified
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|
|
Completed PAD Induction
Patient choice
|
0
|
1
|
0
|
|
Completed PAD Induction
Disease progression
|
0
|
2
|
0
|
|
Completed PAD Induction
Adverse Event
|
4
|
0
|
0
|
|
Completed PAD Induction
Death
|
1
|
1
|
0
|
|
Primary Endpoint Analysis
Other
|
1
|
2
|
0
|
|
Primary Endpoint Analysis
Patient choice
|
0
|
1
|
0
|
|
Primary Endpoint Analysis
Efficacy data unavailable
|
0
|
2
|
0
|
|
Primary Endpoint Analysis
Patient response missing
|
0
|
0
|
1
|
|
Completed 3-month Follow up
Other
|
0
|
2
|
0
|
|
Completed 3-month Follow up
Physician Decision
|
0
|
1
|
0
|
|
Secondary Endpoint Analysis
Efficacy data unavailable
|
0
|
2
|
1
|
Baseline Characteristics
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
1q21 Amplified
n=26 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Not Amplified
n=72 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=9 Participants
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
55.6 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
57.9 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mauritian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
South American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Appears White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.
International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour
Outcome measures
| Measure |
1q21 Not Amplified
n=63 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=20 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=8 Participants
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=91 Participants
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Non Responder
|
8 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
|
Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Responder
|
55 Participants
|
20 Participants
|
7 Participants
|
82 Participants
|
|
Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Total
|
63 Participants
|
20 Participants
|
8 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).
Outcome measures
| Measure |
1q21 Not Amplified
n=63 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=20 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=8 Participants
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=91 Participants
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
stringent complete response (sCR)
|
5 Particiipants
|
3 Particiipants
|
1 Particiipants
|
9 Particiipants
|
|
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
complete response (CR)
|
6 Particiipants
|
3 Particiipants
|
0 Particiipants
|
9 Particiipants
|
|
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Very Good Partial Response (VGPR)
|
15 Particiipants
|
3 Particiipants
|
3 Particiipants
|
21 Particiipants
|
|
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Partial Response (PR)
|
29 Particiipants
|
11 Particiipants
|
3 Particiipants
|
43 Particiipants
|
|
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Stable Disease (SD)
|
8 Particiipants
|
0 Particiipants
|
1 Particiipants
|
9 Particiipants
|
|
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Total
|
63 Particiipants
|
20 Particiipants
|
8 Particiipants
|
91 Particiipants
|
SECONDARY outcome
Timeframe: 3-months following ASCTPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.
Outcome measures
| Measure |
1q21 Not Amplified
n=58 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=20 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=7 Participants
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=85 Participants
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
Non Responder
|
4 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
Responder
|
54 Participants
|
20 Participants
|
7 Participants
|
81 Participants
|
|
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
Total
|
58 Participants
|
20 Participants
|
7 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 3-months after ASCTPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.
Outcome measures
| Measure |
1q21 Not Amplified
n=58 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=20 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=7 Participants
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=85 Participants
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
stringent complete response (sCR)
|
6 Participants
|
5 Participants
|
3 Participants
|
14 Participants
|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
complete response (CR)
|
8 Participants
|
3 Participants
|
0 Participants
|
11 Participants
|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Very Good Partial Response (VGPR)
|
21 Participants
|
7 Participants
|
1 Participants
|
29 Participants
|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Partial Response (PR)
|
19 Participants
|
5 Participants
|
3 Participants
|
27 Participants
|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Stable Disease (SD)
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Relapse
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Total
|
58 Participants
|
20 Participants
|
7 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 2 years after Day 1 Cycle 1 of PADPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Outcome measures
| Measure |
1q21 Not Amplified
n=58 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=20 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Event Free Survival (EFS)
|
75.0 Percentage of participants
|
69.6 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 years after Day 1 Cycle 1 of PADPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Outcome measures
| Measure |
1q21 Not Amplified
n=58 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=20 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Survival
|
93.8 Percentage of participants
|
86.4 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).
Outcome measures
| Measure |
1q21 Not Amplified
n=42 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=19 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=8 Participants
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=69 Participants
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Assessment of Quality of Life (AQoL) Scores
|
0.0516596 Scores on a scale
Standard Deviation 0.2769184
|
0.0068695 Scores on a scale
Standard Deviation 0.3366162
|
0.1267145 Scores on a scale
Standard Deviation 0.1839149
|
0.0480281 Scores on a scale
Standard Deviation 0.2844673
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).
Outcome measures
| Measure |
1q21 Not Amplified
n=75 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=14 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Stratified by Protein Expression (p53)
p53 Non Responder
|
14 Participants
|
3 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) Stratified by Protein Expression (p53)
p53 Responder
|
61 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).
Outcome measures
| Measure |
1q21 Not Amplified
n=59 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=25 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).
Cyclin D1 Non Responder
|
11 Participants
|
5 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).
Cyclin D1 Responder
|
48 Participants
|
20 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)
Outcome measures
| Measure |
1q21 Not Amplified
n=12 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=77 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)
bcl-2 Non Responder
|
2 Participants
|
15 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)
bcl-2 Responder
|
10 Participants
|
62 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)
Outcome measures
| Measure |
1q21 Not Amplified
n=78 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=11 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)
FGFR3 Non Responder
|
14 Participants
|
2 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)
FGFR3 Responder
|
64 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 years after Day 1 Cycle 1 of PADPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).
Outcome measures
| Measure |
1q21 Not Amplified
n=65 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=13 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Survival (OS) Stratified by Protein Expression (p53).
|
90.7 Percentage of participants
|
92.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 years after Day 1 Cycle 1 of PADPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).
Outcome measures
| Measure |
1q21 Not Amplified
n=49 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=24 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)
|
89.8 Percentage of participants
|
95.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 years after Day 1 Cycle 1 of PADPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).
Outcome measures
| Measure |
1q21 Not Amplified
n=12 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=66 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Survival (OS) Stratified by Protein Expression (Bcl-2)
|
91.7 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 years after Day 1 Cycle 1 of PADPopulation: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).
Outcome measures
| Measure |
1q21 Not Amplified
n=67 Participants
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Amplified
n=11 Participants
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Overall Survival (OS) Stratified by Protein Expression (FGFR3)
|
92.5 Percentage of participants
|
81.8 Percentage of participants
|
—
|
—
|
Adverse Events
1q21 Amplified
Serious events: 15 serious events
Other events: 26 other events
Deaths: 0 deaths
1q21 Not Amplified
Serious events: 30 serious events
Other events: 72 other events
Deaths: 0 deaths
Failed/Missing Test
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Total
Serious events: 50 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1q21 Amplified
n=26 participants at risk
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Not Amplified
n=72 participants at risk
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=9 participants at risk
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=107 participants at risk
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
11.1%
1/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.8%
1/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Cardiac disorders
Cardiac Amyloidosis
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Cardiac disorders
Cardiac Failure
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 2 years
|
8.3%
6/72 • 2 years
|
0.00%
0/9 • 2 years
|
5.6%
6/107 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • 2 years
|
4.2%
3/72 • 2 years
|
0.00%
0/9 • 2 years
|
2.8%
3/107 • 2 years
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • 2 years
|
6.9%
5/72 • 2 years
|
0.00%
0/9 • 2 years
|
4.7%
5/107 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
General disorders
Chest Pain
|
0.00%
0/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
General disorders
Fatigue
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
General disorders
Gait Disturbance
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
General disorders
Oedema
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
General disorders
Pyrexia
|
7.7%
2/26 • 2 years
|
6.9%
5/72 • 2 years
|
22.2%
2/9 • 2 years
|
8.4%
9/107 • 2 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Infections and infestations
Device Related Infection
|
3.8%
1/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Infections and infestations
H1N1 Influenza
|
7.7%
2/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
11.1%
1/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Infections and infestations
Herpes Zoster Ophthalmic
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Infections and infestations
Infection
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Infections and infestations
Influenza
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/26 • 2 years
|
6.9%
5/72 • 2 years
|
0.00%
0/9 • 2 years
|
4.7%
5/107 • 2 years
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • 2 years
|
8.3%
6/72 • 2 years
|
22.2%
2/9 • 2 years
|
9.3%
10/107 • 2 years
|
|
Infections and infestations
Pneumonia Viral
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Infections and infestations
Sinusitis
|
7.7%
2/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Infections and infestations
Streptococcal Infection
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/26 • 2 years
|
0.00%
0/72 • 2 years
|
11.1%
1/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Injury, poisoning and procedural complications
Urinary Retention Postoperative
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Investigations
Blood Creatine Increased
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Investigations
Cardioactive Drug Level Increased
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Investigations
Chest X-Ray Abnormal
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.7%
2/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
2/26 • 2 years
|
6.9%
5/72 • 2 years
|
0.00%
0/9 • 2 years
|
6.5%
7/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
3/26 • 2 years
|
4.2%
3/72 • 2 years
|
0.00%
0/9 • 2 years
|
5.6%
6/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Nervous system disorders
Autonomic Neuropathy
|
0.00%
0/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Nervous system disorders
Facial Palsy
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Nervous system disorders
Neuropathy Peripheral
|
3.8%
1/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
2.8%
3/107 • 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • 2 years
|
2.8%
2/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Psychiatric disorders
Delirium
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
2/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
1.9%
2/107 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Skin and subcutaneous tissue disorders
Acute Febrile Neutrophilic Dermatosis
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Surgical and medical procedures
Pain Management
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • 2 years
|
0.00%
0/72 • 2 years
|
0.00%
0/9 • 2 years
|
0.93%
1/107 • 2 years
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/26 • 2 years
|
1.4%
1/72 • 2 years
|
11.1%
1/9 • 2 years
|
1.9%
2/107 • 2 years
|
Other adverse events
| Measure |
1q21 Amplified
n=26 participants at risk
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
1q21 Not Amplified
n=72 participants at risk
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Failed/Missing Test
n=9 participants at risk
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
Total
n=107 participants at risk
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
8/26 • 2 years
|
20.8%
15/72 • 2 years
|
33.3%
3/9 • 2 years
|
24.3%
26/107 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
6/26 • 2 years
|
16.7%
12/72 • 2 years
|
0.00%
0/9 • 2 years
|
16.8%
18/107 • 2 years
|
|
Eye disorders
Vision Blurred
|
7.7%
2/26 • 2 years
|
8.3%
6/72 • 2 years
|
22.2%
2/9 • 2 years
|
9.3%
10/107 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
2/26 • 2 years
|
6.9%
5/72 • 2 years
|
11.1%
1/9 • 2 years
|
7.5%
8/107 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
65.4%
17/26 • 2 years
|
58.3%
42/72 • 2 years
|
66.7%
6/9 • 2 years
|
60.7%
65/107 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
34.6%
9/26 • 2 years
|
36.1%
26/72 • 2 years
|
33.3%
3/9 • 2 years
|
35.5%
38/107 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
3/26 • 2 years
|
12.5%
9/72 • 2 years
|
11.1%
1/9 • 2 years
|
12.1%
13/107 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
15.4%
4/26 • 2 years
|
9.7%
7/72 • 2 years
|
0.00%
0/9 • 2 years
|
10.3%
11/107 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • 2 years
|
50.0%
36/72 • 2 years
|
55.6%
5/9 • 2 years
|
47.7%
51/107 • 2 years
|
|
Gastrointestinal disorders
Reflux Gastritis
|
3.8%
1/26 • 2 years
|
6.9%
5/72 • 2 years
|
0.00%
0/9 • 2 years
|
5.6%
6/107 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • 2 years
|
20.8%
15/72 • 2 years
|
11.1%
1/9 • 2 years
|
15.9%
17/107 • 2 years
|
|
General disorders
Chest Pain
|
3.8%
1/26 • 2 years
|
11.1%
8/72 • 2 years
|
0.00%
0/9 • 2 years
|
8.4%
9/107 • 2 years
|
|
General disorders
Fatigue
|
26.9%
7/26 • 2 years
|
41.7%
30/72 • 2 years
|
44.4%
4/9 • 2 years
|
38.3%
41/107 • 2 years
|
|
General disorders
Mucosal Inflammation
|
7.7%
2/26 • 2 years
|
9.7%
7/72 • 2 years
|
11.1%
1/9 • 2 years
|
9.3%
10/107 • 2 years
|
|
General disorders
Oedema
|
11.5%
3/26 • 2 years
|
5.6%
4/72 • 2 years
|
0.00%
0/9 • 2 years
|
6.5%
7/107 • 2 years
|
|
General disorders
Oedema Peripheral
|
19.2%
5/26 • 2 years
|
16.7%
12/72 • 2 years
|
22.2%
2/9 • 2 years
|
17.8%
19/107 • 2 years
|
|
General disorders
Pain
|
3.8%
1/26 • 2 years
|
11.1%
8/72 • 2 years
|
11.1%
1/9 • 2 years
|
9.3%
10/107 • 2 years
|
|
General disorders
Pyrexia
|
3.8%
1/26 • 2 years
|
6.9%
5/72 • 2 years
|
11.1%
1/9 • 2 years
|
6.5%
7/107 • 2 years
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
7.7%
2/26 • 2 years
|
12.5%
9/72 • 2 years
|
0.00%
0/9 • 2 years
|
10.3%
11/107 • 2 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/26 • 2 years
|
11.1%
8/72 • 2 years
|
11.1%
1/9 • 2 years
|
8.4%
9/107 • 2 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
15.4%
4/26 • 2 years
|
15.3%
11/72 • 2 years
|
11.1%
1/9 • 2 years
|
15.0%
16/107 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.7%
2/26 • 2 years
|
5.6%
4/72 • 2 years
|
0.00%
0/9 • 2 years
|
5.6%
6/107 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.4%
4/26 • 2 years
|
4.2%
3/72 • 2 years
|
0.00%
0/9 • 2 years
|
6.5%
7/107 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.4%
4/26 • 2 years
|
5.6%
4/72 • 2 years
|
0.00%
0/9 • 2 years
|
7.5%
8/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • 2 years
|
6.9%
5/72 • 2 years
|
11.1%
1/9 • 2 years
|
6.5%
7/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
3/26 • 2 years
|
20.8%
15/72 • 2 years
|
0.00%
0/9 • 2 years
|
16.8%
18/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.8%
1/26 • 2 years
|
5.6%
4/72 • 2 years
|
11.1%
1/9 • 2 years
|
5.6%
6/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
15.4%
4/26 • 2 years
|
6.9%
5/72 • 2 years
|
0.00%
0/9 • 2 years
|
8.4%
9/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.8%
1/26 • 2 years
|
12.5%
9/72 • 2 years
|
0.00%
0/9 • 2 years
|
9.3%
10/107 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
19.2%
5/26 • 2 years
|
11.1%
8/72 • 2 years
|
11.1%
1/9 • 2 years
|
13.1%
14/107 • 2 years
|
|
Nervous system disorders
Areflexia
|
7.7%
2/26 • 2 years
|
8.3%
6/72 • 2 years
|
11.1%
1/9 • 2 years
|
8.4%
9/107 • 2 years
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • 2 years
|
19.4%
14/72 • 2 years
|
11.1%
1/9 • 2 years
|
15.0%
16/107 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
30.8%
8/26 • 2 years
|
19.4%
14/72 • 2 years
|
33.3%
3/9 • 2 years
|
23.4%
25/107 • 2 years
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • 2 years
|
19.4%
14/72 • 2 years
|
0.00%
0/9 • 2 years
|
16.8%
18/107 • 2 years
|
|
Nervous system disorders
Lethargy
|
23.1%
6/26 • 2 years
|
15.3%
11/72 • 2 years
|
0.00%
0/9 • 2 years
|
15.9%
17/107 • 2 years
|
|
Nervous system disorders
Neuralgia
|
11.5%
3/26 • 2 years
|
19.4%
14/72 • 2 years
|
11.1%
1/9 • 2 years
|
16.8%
18/107 • 2 years
|
|
Nervous system disorders
Neuropathy Peripheral
|
57.7%
15/26 • 2 years
|
50.0%
36/72 • 2 years
|
33.3%
3/9 • 2 years
|
50.5%
54/107 • 2 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
3.8%
1/26 • 2 years
|
22.2%
16/72 • 2 years
|
11.1%
1/9 • 2 years
|
16.8%
18/107 • 2 years
|
|
Psychiatric disorders
Anxiety
|
11.5%
3/26 • 2 years
|
6.9%
5/72 • 2 years
|
0.00%
0/9 • 2 years
|
7.5%
8/107 • 2 years
|
|
Psychiatric disorders
Insomnia
|
34.6%
9/26 • 2 years
|
37.5%
27/72 • 2 years
|
33.3%
3/9 • 2 years
|
36.4%
39/107 • 2 years
|
|
Psychiatric disorders
Mood Altered
|
7.7%
2/26 • 2 years
|
6.9%
5/72 • 2 years
|
11.1%
1/9 • 2 years
|
7.5%
8/107 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • 2 years
|
15.3%
11/72 • 2 years
|
44.4%
4/9 • 2 years
|
15.0%
16/107 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.1%
6/26 • 2 years
|
13.9%
10/72 • 2 years
|
0.00%
0/9 • 2 years
|
15.0%
16/107 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
2/26 • 2 years
|
6.9%
5/72 • 2 years
|
22.2%
2/9 • 2 years
|
8.4%
9/107 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.8%
1/26 • 2 years
|
6.9%
5/72 • 2 years
|
11.1%
1/9 • 2 years
|
6.5%
7/107 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.5%
3/26 • 2 years
|
27.8%
20/72 • 2 years
|
22.2%
2/9 • 2 years
|
23.4%
25/107 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
8/26 • 2 years
|
15.3%
11/72 • 2 years
|
11.1%
1/9 • 2 years
|
18.7%
20/107 • 2 years
|
|
Vascular disorders
Orthostatic Hypotension
|
11.5%
3/26 • 2 years
|
8.3%
6/72 • 2 years
|
0.00%
0/9 • 2 years
|
8.4%
9/107 • 2 years
|
Additional Information
Regional Medical Affairs Director Asia Pacific
Jan-Cil Australia
Phone: 61 427564369
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60