Trial Outcomes & Findings for Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT NCT00609167)
NCT ID: NCT00609167
Last Updated: 2011-05-17
Results Overview
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
After 4 months of treatment
Results posted on
2011-05-17
Participant Flow
Sixty-three(63) participants were recruited between December 2006 and October 2008 at either Mayo Clinic Arizona or Princess Margaret Hospital.
Participant milestones
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Disease Progression
|
1
|
0
|
|
Overall Study
Stem Cell Transplant
|
0
|
6
|
Baseline Characteristics
Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Parameters of Hematologic Response - Serum M-spike >=1g/dL
Yes
|
25 participants
n=5 Participants
|
18 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Parameters of Hematologic Response - Serum M-spike >=1g/dL
No
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >=10mg/dL
Yes
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >=10mg/dL
No
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Urine M-Spike >= 200mg/24 hours
Yes
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Urine M-Spike >= 200mg/24 hours
No
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%
Yes
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%
No
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 4 months of treatmentResponse that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment
|
20 participants
|
18 participants
|
SECONDARY outcome
Timeframe: up to 5 yearsPFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase \>= 0.5g/dl) * Urine M-component (absolute increase \>= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * Bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Progression Free Survival (PFS)
|
NA months
The median PFS for group 1 has not been attained.
|
NA months
The median PFS for group 2 has not been attained
|
SECONDARY outcome
Timeframe: From date of registration until death (up to 5 years)OS was defined as the time from registration to death of any cause.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Median OS for group 1 has not been attained.
|
NA months
Median OS for group 2 has not been attained.
|
SECONDARY outcome
Timeframe: 4 cyclesPopulation: Participants who received 4 cycles of treatment were analyzed.
Response that was confirmed on 2 consecutive evaluations after 8 months of treatment. CR, nCR and VGPR as defined in the primary outcome. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles
|
29 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Duration of study (up to 12 cycles)Population: Participants who achieved a partial response(PR) or better were evaluable for this analysis.
Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=29 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=28 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Duration of Response
|
NA months
Median duration of response for group 1 was not attained.
|
NA months
Median duration of response for group 2 was not attained.
|
SECONDARY outcome
Timeframe: After 8 cycles of treatmentPopulation: Participants who received 8 cycles of treatment were analyzed.
Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment. Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=2 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles
|
—
|
1 participants
|
SECONDARY outcome
Timeframe: After 12 cycles of treatmentPopulation: No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.
Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment. Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every cycle during treatment (up to 12 cycles)Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Number of Participants With Severe Adverse Events
|
16 participants
|
11 participants
|
SECONDARY outcome
Timeframe: After 4 cycles of treatmentPopulation: At the time of publication, data was available on 18 patients for group 2.
Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.
Outcome measures
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 Participants
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=18 Participants
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22
Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant
|
33 participants
|
17 participants
|
Adverse Events
CyBorD (Bortezomib 1.3mg/m^2)
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
CyBorD (Bortezomib 1.5mg/m^2)
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 participants at risk
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 participants at risk
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
1/33 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Blood Infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Lung (pneumonia) infection
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
Other adverse events
| Measure |
CyBorD (Bortezomib 1.3mg/m^2)
n=33 participants at risk
Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
|
CyBorD (Bortezomib 1.5mg/m^2)
n=30 participants at risk
Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.1%
4/33 • Number of events 6
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/33
|
6.7%
2/30 • Number of events 4
|
|
Cardiac disorders
Ischemia/Infarction
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/33
|
10.0%
3/30 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Ileus
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Edema limbs
|
3.0%
1/33 • Number of events 1
|
10.0%
3/30 • Number of events 4
|
|
General disorders
Fatigue
|
54.5%
18/33 • Number of events 52
|
80.0%
24/30 • Number of events 75
|
|
Infections and infestations
Bronchus infection
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Conjunctiva infection
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Upper airway infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Fracture
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Creatinine increased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Investigations
Metabolic/Lab
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
42.4%
14/33 • Number of events 30
|
23.3%
7/30 • Number of events 16
|
|
Investigations
Platelet count decreased
|
81.8%
27/33 • Number of events 68
|
36.7%
11/30 • Number of events 28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
6/33 • Number of events 7
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
2/33 • Number of events 2
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
6.1%
2/33 • Number of events 2
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.0%
1/33 • Number of events 2
|
0.00%
0/30
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
63.6%
21/33 • Number of events 52
|
56.7%
17/30 • Number of events 64
|
|
Nervous system disorders
Taste
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Euphoria
|
3.0%
1/33 • Number of events 2
|
0.00%
0/30
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
6.1%
2/33 • Number of events 2
|
0.00%
0/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place