Trial Outcomes & Findings for Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients (NCT NCT00507442)
NCT ID: NCT00507442
Last Updated: 2013-07-26
Results Overview
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very good partial response requires 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 h
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Up to 48 weeks or until disease progression
Results posted on
2013-07-26
Participant Flow
Participant milestones
| Measure |
V-DR
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
66
|
33
|
17
|
|
Overall Study
COMPLETED
|
26
|
39
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
16
|
27
|
15
|
5
|
Reasons for withdrawal
| Measure |
V-DR
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
11
|
4
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
4
|
1
|
|
Overall Study
Progressive Disease
|
2
|
4
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
2
|
1
|
|
Overall Study
Other
|
2
|
5
|
2
|
2
|
Baseline Characteristics
Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
V-DR
n=42 Participants
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=66 Participants
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 Participants
VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Age Continuous
|
59.5 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 9.16 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 8.75 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
66 participants
n=7 Participants
|
33 participants
n=5 Participants
|
17 participants
n=4 Participants
|
158 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks or until disease progressionPopulation: The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very good partial response requires 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 h
Outcome measures
| Measure |
V-DR
n=41 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=40 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=32 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Number of Patients With Combined Complete Response and Very Good Partial Response
|
21 participants
|
23 participants
|
13 participants
|
9 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through the 30 day post-treatment AE assessment visitPopulation: The safety population includes patients received any dose of any study drug.
Evaluate the safety and tolerability of the combination therapy
Outcome measures
| Measure |
V-DR
n=42 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=66 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events (AEs)
|
42 participants
|
65 participants
|
33 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease progressionPopulation: The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.
Overall Response includes complete response and partial response. Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to \< 200 mg per 24 hour.
Outcome measures
| Measure |
V-DR
n=41 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=40 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=32 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Number of Patients With Overall Response
|
35 participants
|
35 participants
|
24 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease progressionPopulation: The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.
Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Outcome measures
| Measure |
V-DR
n=41 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=40 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=32 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Number of Patients With Stringent Complete Response Rate
|
7 participants
|
6 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease progressionPopulation: The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.
Outcome measures
| Measure |
V-DR
n=41 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=40 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=32 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Number of Patients With Complete Response Rate + Near Complete Response Rate
|
17 participants
|
14 participants
|
10 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease progressionPopulation: Responders (patients achieved complete and partial response) in the response evaluable population.
Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
Outcome measures
| Measure |
V-DR
n=35 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=35 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=24 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Duration of Response
|
NA days
Interval 302.0 to
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Interval 583.0 to
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease progressionPopulation: The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
Outcome measures
| Measure |
V-DR
n=42 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=48 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Time to Disease Progression
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Interval 631.0 to
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease responsePopulation: Responders (patients achieved complete and partial response) in the response evaluable population.
Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.
Outcome measures
| Measure |
V-DR
n=35 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=35 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=24 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Time to Response
|
49 days
Interval 43.0 to 175.0
|
50 days
Interval 41.0 to 145.0
|
55 days
Interval 42.0 to 302.0
|
49 days
Interval 42.0 to 194.0
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until disease progression/deathPopulation: The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
Outcome measures
| Measure |
V-DR
n=42 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=48 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Progression-free Survival
|
NA days
Interval 356.0 to
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
631 days
Interval 555.0 to
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Interval 778.0 to
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
SECONDARY outcome
Timeframe: survival probability at 1 year after randomizationPopulation: The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
Outcome measures
| Measure |
V-DR
n=42 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=48 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Probability of 1-year Survival
|
100 percentage of patients
|
91.6 percentage of patients
|
100 percentage of patients
|
100 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 48 weeks or until deathPopulation: The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
Overall survival is defined as time from the date of randomization to the date of death
Outcome measures
| Measure |
V-DR
n=42 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=48 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 Participants
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Overall Survival
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
NA days
Not estimable based on the Kaplan-Meier method because of insufficient follow up time
|
Adverse Events
V-DR
Serious events: 17 serious events
Other events: 41 other events
Deaths: 0 deaths
VDCR
Serious events: 26 serious events
Other events: 65 other events
Deaths: 0 deaths
V-DC
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
VDC-mod
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V-DR
n=42 participants at risk
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=66 participants at risk
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 participants at risk
VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 participants at risk
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia NOS
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Lobar pneumonia NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Septic shock
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Herpes simplex
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Herpes zoster
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Cellulitis
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Urinary tract infection NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Respiratory syncytial virus infection NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Arthritis infective NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Colitis pseudomembranous
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Stye
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Vomiting NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Small intestinal obstruction NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Diverticular perforation NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Antibiotic associated colitis
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Pyrexia
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Fatigue
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Malaise
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Weakness
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Fall
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Oedema peripheral
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Neuralgia NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
2/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Malnutrition NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Vascular disorders
Hypotension NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
2/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Vascular disorders
Venous thrombosis deep limb
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Angina pectoris
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Angina unstable
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Cardiac failure congestive
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Pulmonary oedema NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Pericarditis NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
2/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Renal and urinary disorders
Renal failure NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Renal and urinary disorders
Renal impairment NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Headache NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Convulsions NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Investigations
Blood creatinine increased
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Investigations
Blood culture positive
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Injury, poisoning and procedural complications
Haemothorax
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Injury, poisoning and procedural complications
Compression fracture
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Injury, poisoning and procedural complications
Muscle injury NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Psychiatric disorders
Confusion
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Psychiatric disorders
Agitation
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Hepatobiliary disorders
Hypoproteinaemia
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
0.00%
0/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
Other adverse events
| Measure |
V-DR
n=42 participants at risk
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
VDCR
n=66 participants at risk
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
|
V-DC
n=33 participants at risk
VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
|
VDC-mod
n=17 participants at risk
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Psychiatric disorders
Insomnia
|
33.3%
14/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
31.8%
21/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
27.3%
9/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
35.3%
6/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
33.3%
14/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
36.4%
24/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
45.5%
15/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
52.9%
9/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.5%
17/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
39.4%
26/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
27.3%
9/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Dizziness (excl vertigo)
|
31.0%
13/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
27.3%
18/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
17.6%
3/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Dysgeusia
|
19.0%
8/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
13.6%
9/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
3/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Paraesthesia
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Hypoaesthesia
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Nervous system disorders
Tremor
|
11.9%
5/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Constipation
|
61.9%
26/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
43.9%
29/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
48.5%
16/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
41.2%
7/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
3/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
24.2%
8/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
17.6%
3/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Abdominal distension
|
19.0%
8/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
23.5%
4/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Hiccups
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Oedema lower limb
|
21.4%
9/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
28.8%
19/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
24.2%
8/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
29.4%
5/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Rigors
|
26.2%
11/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
21.2%
14/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
15.2%
5/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
General disorders
Pain NOS
|
14.3%
6/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
10.6%
7/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
7/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
10.6%
7/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Pruritus NOS
|
11.9%
5/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
10.6%
7/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
11.9%
5/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
13.6%
9/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
2/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
17.6%
3/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
28.6%
12/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
33.3%
22/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
36.4%
12/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
41.2%
7/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
3/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.1%
16/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
21.2%
14/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
15.2%
5/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.9%
5/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
3/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Chest wall pain
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
15.2%
5/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.0%
8/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
50.0%
33/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
51.5%
17/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
47.1%
8/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.9%
5/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Anorexia
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
22.7%
15/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
15.2%
5/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
14.3%
6/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
8/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
14.3%
6/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
15.2%
5/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Psychiatric disorders
Anxiety NEC
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
15.2%
10/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Psychiatric disorders
Depression NOS
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
10.6%
7/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Investigations
Weight decreased
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
18.2%
6/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Psychiatric disorders
Weight increased
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
1.5%
1/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
3/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Investigations
Haemoglobin decreased
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
2/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
17.6%
3/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
4/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
8/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Eye disorders
Vision blurred
|
16.7%
7/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
9.1%
6/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
12.1%
4/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
1/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
4.5%
3/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
16.7%
7/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
13.6%
9/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
2/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
11.8%
2/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Gastrointestinal disorders
Day mouth
|
7.1%
3/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
6.1%
4/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
0.00%
0/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
|
Vascular disorders
Flushing
|
4.8%
2/42 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
7.6%
5/66 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
3.0%
1/33 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
5.9%
1/17 • From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
|
Additional Information
Dixie-Lee Esseltine, MD
Millennium Pharmaceuticals, Inc
Phone: (617) 679-7000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place