Trial Outcomes & Findings for Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma (NCT NCT00153920)
NCT ID: NCT00153920
Last Updated: 2019-06-11
Results Overview
Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; \<5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Results posted on
2019-06-11
Participant Flow
66 participants were enrolled between December 2003 and September 2005.
Participant milestones
| Measure |
Bortezomib
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
|
|---|---|
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Overall Study
STARTED
|
66
|
|
Overall Study
Eligible and Treated
|
64
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Bortezomib
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Progressive Disease
|
9
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Lack of Response
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Non-Protocol Therapy
|
1
|
|
Overall Study
Withdrawal of Consent before Trt
|
1
|
|
Overall Study
Progressive Disease before Trt
|
1
|
Baseline Characteristics
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
59 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
|
ISS Stage
ISS Stage I
|
32 participants
n=5 Participants
|
|
ISS Stage
ISS Stage II
|
26 participants
n=5 Participants
|
|
ISS Stage
ISS Stage III
|
4 participants
n=5 Participants
|
|
ISS Stage
Unknown
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).Population: The analysis population is comprised of eligible and treated participants.
Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; \<5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.
Outcome measures
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
|
Objective Response (OR) Rate
|
0.41 proportion of participants
Interval 0.3 to 0.52
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SECONDARY outcome
Timeframe: Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).Population: The analysis population is comprised of eligible and treated participants.
Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a \>90% decrease in the difference between involved and uninvolved FLC levels.
Outcome measures
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
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Very Good Partial Response (VGPR) Rate
|
.17 proportion of participants
Interval 0.089 to 0.287
|
SECONDARY outcome
Timeframe: Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.Population: The analysis population is comprised of eligible and treated participants.
TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: \>25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); \>25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); \>25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL not attributable to other cause).
Outcome measures
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
|
Time to Progression (TTP)
|
17.3 months
Interval 10.6 to 23.0
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SECONDARY outcome
Timeframe: Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.Population: The analysis population is comprised of eligible and treated participants.
PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: \>25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); \>25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); \>25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL not attributable to other cause).
Outcome measures
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
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Progression-Free Survival (PFS)
|
17.0 months
Interval 8.6 to 21.5
|
SECONDARY outcome
Timeframe: Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).Population: The analysis population is comprised of eligible and treated participants.
Number of participants experiencing any grade treatment-emergent sensory neuropathy events based on CTCAEv3 as reported on case report forms.
Outcome measures
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
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Number of Participants With Treatment-Emergent Sensory Neuropathy
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41 participants
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SECONDARY outcome
Timeframe: Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).Population: The analysis population is comprised of eligible and treated participants.
Number of participants experiencing any grade treatment-emergent neuropathic pain events based on CTCAEv3 as reported on case report forms.
Outcome measures
| Measure |
Bortezomib
n=64 Participants
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
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Number of Participants With Treatment-Emergent Neuropathic Pain
|
8 participants
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Adverse Events
Bortezomib
Serious events: 33 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib
n=64 participants at risk
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
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|---|---|
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Gastrointestinal disorders
Constipation
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fever w/o neutropenia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema limb
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Pain-other
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection-other
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Lymphopenia
|
21.9%
14/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathy-motor
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathy-sensory
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Syncope
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathic, pain
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Depression
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypotension
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Other adverse events
| Measure |
Bortezomib
n=64 participants at risk
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
|
|---|---|
|
Nervous system disorders
Tinnitus
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection w/ unk ANC upper airway NOS
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Encephalopathy
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Dry eye syndrome
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Double vision
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Vision-blurred
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Tearing
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Ocular-other
|
10.9%
7/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
32/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
31.2%
20/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
51.6%
33/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Vomiting
|
14.1%
9/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
GI-other
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Oral cavity, hemorrhage
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Abdomen, pain
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Stomach, pain
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
40.6%
26/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fever w/o neutropenia
|
9.4%
6/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Rigors/chills
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Constitutional, other
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema head and neck
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema limb
|
9.4%
6/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Pain-other
|
14.1%
9/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Immune system disorders
Allergic reaction
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Immune system disorders
Allergy-other
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut, eye NOS
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection-other
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
28.1%
18/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Lymphopenia
|
10.9%
7/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
12.5%
8/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
39.1%
25/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Weight gain
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Weight loss
|
10.9%
7/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Alkaline phosphatase
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
ALT, SGPT
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Amylase
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
AST, SGOT
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.6%
10/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
17.2%
11/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
9.4%
6/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
7.8%
5/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Taste disturbance
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Ataxia
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Dizziness
|
12.5%
8/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathy-motor
|
7.8%
5/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathy-sensory
|
60.9%
39/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neurologic-other
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
14.1%
9/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathic, pain
|
7.8%
5/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Insomnia
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Depression
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Renal and urinary disorders
Renal/GU-other
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Breast, pain
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Pelvic, pain
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Testicle, pain
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Uterus, pain
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Erectile impotence
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Sexual/Reproductive function-Other
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
3/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.1%
2/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.4%
15/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypotension
|
6.2%
4/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hot flashes
|
1.6%
1/64 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with bortezomib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with bortezomib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place