Trial Outcomes & Findings for Velcade (Bortezomib) Consolidation After Transplant (NCT NCT01539083)
NCT ID: NCT01539083
Last Updated: 2025-02-04
Results Overview
CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
256 participants
Primary outcome timeframe
Month 12
Results posted on
2025-02-04
Participant Flow
The study consisted of 2 treatment phases: induction and consolidation. Participants who completed the induction phase were randomized to enter in the consolidation treatment phase.
Participant milestones
| Measure |
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
|
Thalidomide + Prednisolone (TP Consolidation)
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|---|
|
Before Randomization (VCD Induction)
STARTED
|
256
|
0
|
0
|
|
Before Randomization (VCD Induction)
Treated
|
254
|
0
|
0
|
|
Before Randomization (VCD Induction)
COMPLETED
|
203
|
0
|
0
|
|
Before Randomization (VCD Induction)
NOT COMPLETED
|
53
|
0
|
0
|
|
After Randomization (TP and VTP)
STARTED
|
0
|
100
|
103
|
|
After Randomization (TP and VTP)
Safety Population
|
0
|
99
|
103
|
|
After Randomization (TP and VTP)
COMPLETED
|
0
|
79
|
80
|
|
After Randomization (TP and VTP)
NOT COMPLETED
|
0
|
21
|
23
|
Reasons for withdrawal
| Measure |
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
|
Thalidomide + Prednisolone (TP Consolidation)
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|---|
|
Before Randomization (VCD Induction)
Withdrawal by Subject
|
4
|
0
|
0
|
|
Before Randomization (VCD Induction)
Adverse Event
|
14
|
0
|
0
|
|
Before Randomization (VCD Induction)
Death
|
6
|
0
|
0
|
|
Before Randomization (VCD Induction)
Protocol Violation
|
2
|
0
|
0
|
|
Before Randomization (VCD Induction)
Physician Decision
|
14
|
0
|
0
|
|
Before Randomization (VCD Induction)
Progressive Disease
|
8
|
0
|
0
|
|
Before Randomization (VCD Induction)
Other
|
5
|
0
|
0
|
|
After Randomization (TP and VTP)
Physician Decision
|
0
|
0
|
1
|
|
After Randomization (TP and VTP)
Other
|
0
|
1
|
1
|
|
After Randomization (TP and VTP)
Adverse Event
|
0
|
1
|
1
|
|
After Randomization (TP and VTP)
Lost to Follow-up
|
0
|
2
|
2
|
|
After Randomization (TP and VTP)
Withdrawal by Subject
|
0
|
5
|
4
|
|
After Randomization (TP and VTP)
Progressive Disease
|
0
|
6
|
3
|
|
After Randomization (TP and VTP)
Death
|
0
|
6
|
11
|
Baseline Characteristics
Velcade (Bortezomib) Consolidation After Transplant
Baseline characteristics by cohort
| Measure |
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
n=254 Participants
Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
|
|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
207 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Republic of Korea
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=96 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=98 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
|
81.3 percentage of participants
|
92.9 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9 and 12Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=96 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=98 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
Month 3
|
36.5 percentage of participants
|
36.7 percentage of participants
|
|
Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
Month 6
|
44.8 percentage of participants
|
44.9 percentage of participants
|
|
Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
Month 9
|
49.0 percentage of participants
|
52.0 percentage of participants
|
|
Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
Month 12
|
51.0 percentage of participants
|
53.1 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9 and 12Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=96 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=98 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
Month 9
|
26.0 percentage of participants
|
30.6 percentage of participants
|
|
Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
Month 3
|
20.8 percentage of participants
|
23.5 percentage of participants
|
|
Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
Month 6
|
27.1 percentage of participants
|
28.6 percentage of participants
|
|
Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
Month 12
|
26.0 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until progressive disease (up to 5 years)Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of \>= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be \>=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=96 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=98 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
22.05 months
Interval 18.46 to 25.49
|
22.51 months
Interval 18.56 to 24.15
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, 'N' (number of participants analyzed) signifies the participants who had complete response.
DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of \>= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=56 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=62 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Disease-free Survival (DFS)
|
18.53 months
Interval 11.24 to 23.36
|
13.37 months
Interval 10.18 to 20.96
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.
OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=100 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=103 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Median and 95% CI was not estimable due to insufficient number of events.
|
NA months
Median and 95% CI was not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.
The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=83 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=86 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
Independent Living
|
0.15 units on a scale
Standard Deviation 0.335
|
0.14 units on a scale
Standard Deviation 0.397
|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
Relationships
|
0.06 units on a scale
Standard Deviation 0.300
|
0.05 units on a scale
Standard Deviation 0.296
|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
Mental Health
|
0.18 units on a scale
Standard Deviation 0.319
|
0.18 units on a scale
Standard Deviation 0.270
|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
Coping
|
0.08 units on a scale
Standard Deviation 0.278
|
0.05 units on a scale
Standard Deviation 0.237
|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
Pain
|
0.20 units on a scale
Standard Deviation 0.373
|
0.20 units on a scale
Standard Deviation 0.395
|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
Senses
|
0.03 units on a scale
Standard Deviation 0.140
|
0.00 units on a scale
Standard Deviation 0.137
|
|
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
AQoL-6D Utility score
|
0.11 units on a scale
Standard Deviation 0.216
|
0.11 units on a scale
Standard Deviation 0.213
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.
Outcome measures
| Measure |
Thalidomide + Prednisolone [TP Consolidation]
n=83 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
n=86 Participants
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|
|
Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase
|
2.9 units on a scale
Standard Deviation 19.68
|
1.0 units on a scale
Standard Deviation 19.69
|
Adverse Events
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
Serious events: 88 serious events
Other events: 233 other events
Deaths: 0 deaths
Thalidomide + Prednisolone (TP Consolidation)
Serious events: 22 serious events
Other events: 95 other events
Deaths: 0 deaths
Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
Serious events: 28 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
n=254 participants at risk
Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
|
Thalidomide + Prednisolone (TP Consolidation)
n=99 participants at risk
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
n=103 participants at risk
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
1.2%
3/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Circulatory Collapse
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism Venous
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Vasculitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.3%
11/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Eye disorders
Blepharitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal Spasm
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Adverse Drug Reaction
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
4.7%
12/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacillus Infection
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Device Related Sepsis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatitis B
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.0%
2/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.9%
2/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Zoster Disseminated
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Lobar Pneumonia
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.0%
2/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.6%
4/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.9%
2/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung Infection
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.0%
5/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.8%
7/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia Influenzal
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.0%
2/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.9%
2/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.6%
4/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral Infection
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Investigations
Cytomegalovirus Test Positive
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.6%
4/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.0%
2/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Embolic Stroke
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Impairment
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Paralysis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.9%
2/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction)
n=254 participants at risk
Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
|
Thalidomide + Prednisolone (TP Consolidation)
n=99 participants at risk
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
|
Bortezomib + Thalidomide + Prednisolone (VTP Consolidation)
n=103 participants at risk
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
25/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
17/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
4.9%
5/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.1%
5/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.8%
8/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Eye disorders
Vision Blurred
|
3.1%
8/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
8.1%
8/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.8%
7/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Eye disorders
Visual Impairment
|
0.39%
1/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.9%
2/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
35.8%
91/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
38.4%
38/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
28.2%
29/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.6%
32/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
14.1%
14/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
14.6%
15/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.4%
6/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
4.0%
4/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.8%
6/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
14/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
3.0%
3/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
32.3%
82/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
10.1%
10/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
11.7%
12/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
32/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.1%
7/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Chest Pain
|
3.5%
9/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.1%
5/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.9%
2/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
24.0%
61/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
18.2%
18/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
15.5%
16/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Injection Site Rash
|
5.5%
14/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.97%
1/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Injection Site Reaction
|
7.5%
19/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.8%
7/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
17.3%
44/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
15.2%
15/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
15.5%
16/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Zoster
|
3.1%
8/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
10.1%
10/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
4.9%
5/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.6%
4/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.1%
5/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.8%
6/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
5/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.1%
5/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
9.7%
10/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.4%
29/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
32.3%
32/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
37.9%
39/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
4/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Investigations
Weight Increased
|
2.8%
7/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
26.3%
26/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
16.5%
17/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.5%
19/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
1.0%
1/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
12/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
4.9%
5/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
13/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.8%
7/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.4%
24/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
9.1%
9/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
11.7%
12/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.4%
6/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
9.1%
9/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
10.7%
11/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.0%
5/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.1%
5/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
3.9%
4/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.5%
14/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.0%
2/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.9%
3/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.1%
13/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.1%
7/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.8%
7/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
9.1%
23/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.1%
7/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.8%
7/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
21/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
2.0%
2/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
0.00%
0/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
21/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
8.1%
8/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
4.9%
5/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
3.9%
10/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.8%
6/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
6.3%
16/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
3.0%
3/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.8%
6/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
7.5%
19/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
14.1%
14/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
15.5%
16/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy Peripheral
|
13.4%
34/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
24.2%
24/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
29.1%
30/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
4.3%
11/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.1%
7/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
8.7%
9/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
24.4%
62/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
38.4%
38/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
36.9%
38/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
4.7%
12/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
11.1%
11/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
10.7%
11/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
22.0%
56/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
22.2%
22/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
12.6%
13/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mood Altered
|
3.5%
9/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.1%
5/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
4.9%
5/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
14/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
8.1%
8/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
14.6%
15/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.3%
16/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.1%
7/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.8%
6/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
2.8%
7/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
3.0%
3/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
5.8%
6/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
22/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
7.1%
7/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
9.7%
10/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.79%
2/254
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
6.1%
6/99
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
3.9%
4/103
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER