Trial Outcomes & Findings for Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD (NCT NCT00908232)
NCT ID: NCT00908232
Last Updated: 2015-01-15
Results Overview
Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days
Results posted on
2015-01-15
Participant Flow
190 patients screened, 163 enrolled and received Bortezomib-Dexamethasone (VD) . Participants that completed cycles 1 to 4 were assessed for Response. Complete or Partial Responders were not randomized and continued on VD for cycles 5-8. Participants with Stable Disease (SD) were randomized to either VD, VDC, or VDR for cycles 5-8.
Participant milestones
| Measure |
Cycle 1 to 4: Bortezomib + Dexamethasone (VD)
bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
|
Stable Disease: Bortezomib + Dexamethasone (VD)
Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)
Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
|
SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)
Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|---|---|
|
Cycle 1 to 4
STARTED
|
163
|
0
|
0
|
0
|
|
Cycle 1 to 4
COMPLETED
|
135
|
0
|
0
|
0
|
|
Cycle 1 to 4
NOT COMPLETED
|
28
|
0
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
STARTED
|
98
|
7
|
8
|
4
|
|
Randomization (Cycle 5) to Cycle 8
COMPLETED
|
63
|
4
|
7
|
4
|
|
Randomization (Cycle 5) to Cycle 8
NOT COMPLETED
|
35
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cycle 1 to 4: Bortezomib + Dexamethasone (VD)
bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
|
Stable Disease: Bortezomib + Dexamethasone (VD)
Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)
Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
|
SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)
Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|---|---|
|
Cycle 1 to 4
Death
|
5
|
0
|
0
|
0
|
|
Cycle 1 to 4
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
|
Cycle 1 to 4
Progressive Disease
|
6
|
0
|
0
|
0
|
|
Cycle 1 to 4
Adverse Event
|
12
|
0
|
0
|
0
|
|
Cycle 1 to 4
Other
|
1
|
0
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Complete Response/Partial Response
|
1
|
0
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Progressive Disease
|
5
|
0
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Death
|
2
|
0
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Withdrawal by Subject
|
4
|
0
|
1
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Adverse Event
|
17
|
2
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Physician Decision
|
2
|
0
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Other
|
3
|
1
|
0
|
0
|
|
Randomization (Cycle 5) to Cycle 8
Protocol Violation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD
Baseline characteristics by cohort
| Measure |
All Study Participants
n=163 Participants
bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 11.04 • n=93 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
20 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=93 Participants
|
|
Region of Enrollment
Greece
|
23 participants
n=93 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Lithuania
|
9 participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
19 participants
n=93 Participants
|
|
Region of Enrollment
Serbia
|
15 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=93 Participants
|
|
Region of Enrollment
Turkey
|
19 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 daysPopulation: mITT: All patients with at least 1 dose and 1 post baseline assessment. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.
Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.
Outcome measures
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=123 Participants
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 Participants
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Overall Best Confirmed Response
|
101 number of participants
|
6 number of participants
|
SECONDARY outcome
Timeframe: At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), up to 168 daysPopulation: mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.
Outcome measures
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 Participants
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 Participants
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Median Time to First Confirmed Response
|
43.0 days
Interval 43.0 to 58.0
|
NA days
Interval 152.0 to
It is not possible to estimate the median time to first response or upper limit for the CI. This is because of the 19 subjects only 6 have an event, the majority is censored.
|
SECONDARY outcome
Timeframe: At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR). Median Follow-Up of 16.9 monthsPopulation: mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Outcome measures
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 Participants
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 Participants
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Progression Free Survival
|
311.0 days
Interval 224.0 to 424.0
|
214.0 days
Interval 198.0 to 234.0
|
SECONDARY outcome
Timeframe: At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), Median Follow-up of 16.9 monthsPopulation: mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
Outcome measures
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 Participants
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 Participants
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Time to Progression
|
366.0 days
Interval 281.0 to 475.0
|
214.0 days
Interval 198.0 to 234.0
|
SECONDARY outcome
Timeframe: At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 yearPopulation: mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.
Outcome measures
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 Participants
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 Participants
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
One Year Survival
|
80 percent probability
Interval 73.0 to 87.0
|
89 percent probability
Interval 62.0 to 97.0
|
SECONDARY outcome
Timeframe: At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 yearPopulation: mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive
Outcome measures
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 Participants
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 Participants
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Overall Survival
|
NA days
Interval 888.0 to
this value could not be calculated due to the limited number of events
|
NA days
Interval 982.0 to
this value could not be calculated due to the limited number of events
|
Adverse Events
Complete to Partial Response: Bortezomib + Dexamethasone
Serious events: 59 serious events
Other events: 137 other events
Deaths: 0 deaths
Stable Disease After 4 Cycles: VD, VDC, VDL
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 participants at risk
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 participants at risk
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Renal and urinary disorders
Renal failure
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Renal and urinary disorders
Urinary Retention
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.69%
1/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Hypotension
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Orthostatic Hypotension
|
1.4%
2/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Aortic Aneurysm
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Aortic Stenosis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Arterial Rupture
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Renal and urinary disorders
Renal Impairment
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
6/144 • Number of events 7 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
1/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Cardiac Failure
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Atrial Fibrilation
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Agina pectoris
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
4/144 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Abdominal Mass
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Gastritis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Ileus
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Nausea
|
0.69%
1/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Vomiting
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Pyrexia
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Oedema Peripheral
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Asthenia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Pneumonia
|
6.2%
9/144 • Number of events 10 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Bronchitis
|
2.1%
3/144 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Bronchopneumonia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Influenza
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Cellulitis
|
0.69%
1/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Herpes Zoster
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Pneumomonia Pneumococcal
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Sepsis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Septic Shock
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Staphylococcal Infection
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Urinary Tract Infection
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Viral Infection
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fraction
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.69%
1/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Investigations
Liver Function Test Abnormal
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Cerebellar Infarction
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Convulsion
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Paraesthesia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Polyneuropathy
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Syncope
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Psychiatric disorders
Depression
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Chest Wall Abscess
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Renal and urinary disorders
Oliguria
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
Other adverse events
| Measure |
Complete to Partial Response: Bortezomib + Dexamethasone
n=144 participants at risk
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
|
Stable Disease After 4 Cycles: VD, VDC, VDL
n=19 participants at risk
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.1%
52/144 • Number of events 216 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
42.1%
8/19 • Number of events 22 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.1%
29/144 • Number of events 79 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
31.6%
6/19 • Number of events 14 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
10/144 • Number of events 20 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 7 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
8/144 • Number of events 37 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Eye disorders
Conjunctivitis
|
5.6%
8/144 • Number of events 10 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
45/144 • Number of events 81 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
26.3%
5/19 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
45/144 • Number of events 66 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
26.3%
5/19 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
16/144 • Number of events 23 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
8/144 • Number of events 8 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
11/144 • Number of events 15 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
10/144 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Oedema Peripheral
|
26.4%
38/144 • Number of events 49 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
26.3%
5/19 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Fatigue
|
25.7%
37/144 • Number of events 62 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Asthenia
|
20.1%
29/144 • Number of events 36 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
21.1%
4/19 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Pyrexia
|
10.4%
15/144 • Number of events 15 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
21.1%
4/19 • Number of events 12 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Chest discomfort
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Bronchitis
|
9.0%
13/144 • Number of events 17 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Herpes Zoster
|
8.3%
12/144 • Number of events 12 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
12/144 • Number of events 17 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
9/144 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Oral Candidiasis
|
5.6%
8/144 • Number of events 10 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.6%
11/144 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.6%
21/144 • Number of events 28 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
14/144 • Number of events 15 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.6%
11/144 • Number of events 19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.7%
14/144 • Number of events 25 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.6%
11/144 • Number of events 13 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
20.1%
29/144 • Number of events 80 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
21.1%
4/19 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Polyneuropathy
|
18.1%
26/144 • Number of events 40 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Neuralgia
|
15.3%
22/144 • Number of events 33 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
21.1%
4/19 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Neuropathy Peripheral
|
14.6%
21/144 • Number of events 42 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Paraesthesia
|
13.2%
19/144 • Number of events 27 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Hypoaesthesia
|
9.0%
13/144 • Number of events 19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Dizziness
|
9.0%
13/144 • Number of events 17 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Headache
|
6.2%
9/144 • Number of events 13 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Psychiatric disorders
Insomnia
|
10.4%
15/144 • Number of events 19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.3%
22/144 • Number of events 27 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
21.1%
4/19 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
9/144 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
15.8%
3/19 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
6.2%
9/144 • Number of events 10 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Hypotension
|
7.6%
11/144 • Number of events 17 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Orthostatic Hypotension
|
6.2%
9/144 • Number of events 15 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
8/144 • Number of events 11 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
0.00%
0/19 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Tachycardia
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Sinus tachycardia
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Eye disorders
Lacrimation increased
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
4/144 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Toothache
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Generalised oedema
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
General disorders
Localised oedema
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
5/144 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.8%
4/144 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Respiratory tract infection
|
2.8%
4/144 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Cellulitis
|
2.1%
3/144 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Oral herpes
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Infections and infestations
Oral infection
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Investigations
Platelet count decreased
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Investigations
Haemoglobin decreased
|
0.69%
1/144 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
6/144 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.2%
6/144 • Number of events 8 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.5%
5/144 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Balance disorder
|
1.4%
2/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Psychiatric disorders
Confusional state
|
3.5%
5/144 • Number of events 5 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Psychiatric disorders
Anxiety
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
4/144 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
21.1%
4/19 • Number of events 4 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.9%
7/144 • Number of events 10 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
2/144 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
6/144 • Number of events 6 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Flushing
|
1.4%
2/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
10.5%
2/19 • Number of events 2 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Haematoma
|
0.69%
1/144 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Aortic elongation
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/144 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
|
Vascular disorders
Hypertension
|
2.1%
3/144 • Number of events 3 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
5.3%
1/19 • Number of events 1 • From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.
|
Additional Information
EMEA Medical Affairs Director Oncology
Janssen-Cilag Germany
Phone: +49 2137 955-492
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60