Trial Outcomes & Findings for Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma (NCT NCT01572480)
NCT ID: NCT01572480
Last Updated: 2025-04-22
Results Overview
MRDnegative Complete Response (CR) per the IMWHG criteria is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
8 months
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
All Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Participants Enrolled
STARTED
|
55
|
|
Participants Enrolled
COMPLETED
|
54
|
|
Participants Enrolled
NOT COMPLETED
|
1
|
|
Drug Administration
STARTED
|
54
|
|
Drug Administration
COMPLETED
|
53
|
|
Drug Administration
NOT COMPLETED
|
1
|
|
Initiated Maintenance Therapy
STARTED
|
53
|
|
Initiated Maintenance Therapy
COMPLETED
|
50
|
|
Initiated Maintenance Therapy
NOT COMPLETED
|
3
|
|
Completed Maintenance Therapy
STARTED
|
50
|
|
Completed Maintenance Therapy
COMPLETED
|
30
|
|
Completed Maintenance Therapy
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
All Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Participants Enrolled
Withdrawal by Subject
|
1
|
|
Drug Administration
Discontinued drug/Off Study
|
1
|
|
Initiated Maintenance Therapy
Discontinued maintenance therapy/experienced adverse events and withdrew consent
|
1
|
|
Initiated Maintenance Therapy
Discontinued maintenance therapy/experienced adverse events
|
2
|
Baseline Characteristics
Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
All Participants
n=55 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
60.83 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Northeast
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Southeast
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Southwest
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States · West
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Missing
|
1 Participants
n=5 Participants
|
|
Cytogenetic Risk Group
High Risk
|
20 Participants
n=5 Participants
|
|
Cytogenetic Risk Group
Standard Risk
|
27 Participants
n=5 Participants
|
|
Cytogenetic Risk Group
Unknown
|
7 Participants
n=5 Participants
|
|
Myeloma-defining event per International Myeloma Working Group (IMWG) 2014
|
10 events
n=5 Participants
|
|
High-risk Smoldering Multiple Myeloma by Programa de Estudio y Tratamiento de las Hemopatías Maligna
|
36 Participants
n=5 Participants
|
|
Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2008
|
8 Participants
n=5 Participants
|
|
Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2018
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: 54/55 participants are evaluable for this outcome measure.
MRDnegative Complete Response (CR) per the IMWHG criteria is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher.
Outcome measures
| Measure |
All Participants
n=54 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria
|
70.4 percentage of participants
Interval 56.4 to 82.0
|
SECONDARY outcome
Timeframe: 1 yearPercentage of participants that have Minimal Residual Disease (MRD)-negative Complete Response (CR) for a minimum of 1 year estimated along with a 95% two-sided confidence interval. MRDnegative Complete Response (CR) is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher.
Outcome measures
| Measure |
All Participants
n=54 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants That Have Minimal Residual Disease (MRD)-Negative Complete Response (CR) for a Minimum of 1 Year
|
63 percentage of participants
Interval 49.0 to 76.0
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 117 months and 1 day.Population: 54/55 participants are evaluable for this outcome measure.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants
n=54 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
54 Participants
|
SECONDARY outcome
Timeframe: time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, up to 5 yearsPopulation: 54/55 participants are evaluable for this outcome measure.
Clinical progression was assessed by the International Myeloma Working Group Criteria for Multiple Myeloma. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
All Participants
n=54 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Clinical Progression Free Survival
|
90.7 percentage of participants
Interval 71.0 to 97.2
|
SECONDARY outcome
Timeframe: time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by IMWG criteria, up to 5 yearsPopulation: 54/55 participants are evaluable for this outcome measure.
Biochemical progression free survival is defined as the time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by International Myeloma Working Group (IMWG) criteria. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.
Outcome measures
| Measure |
All Participants
n=54 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Biochemical Progression Free Survival
|
76.6 percentage of participants
Interval 59.2 to 87.3
|
SECONDARY outcome
Timeframe: time from partial response to disease progression, up to 5 yearsDuration of response is defined as the time from partial response to disease progression. Response was assessed by the International Myeloma Working Group Criteria for Multiple Myeloma. Partial Response is ≥50% reduction if serum M-protein and reduction in 24-hour(h) urinary M-protein by ≥90% or to \<200mg per 24h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time measurement criteria are met for best response until the first date that recurrent or progressive disease is met, up to 5 yearsPopulation: 54/55 participants are evaluable for this outcome measure.
Overall response is defined as the percentage of participants who have a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) defined by the International Myeloma Working Group Criteria for Multiple Myeloma out of all evaluable participants. PR is ≥50% reduction if serum M-protein and reduction in 24-hour(h) urinary M-protein by ≥90% or to \<200mg per 24h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis. CR is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≥5% plasma cells in bone marrow. sCR is complete response plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Outcome measures
| Measure |
All Participants
n=54 Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
Overall Response Rate
|
100 percentage of participants
|
|
Overall Response Rate
Partial Response
|
5.5 percentage of participants
|
|
Overall Response Rate
Very Good Partial Response
|
18.5 percentage of participants
|
|
Overall Response Rate
Complete Response
|
0 percentage of participants
|
|
Overall Response Rate
Stringent Complete Response
|
75.9 percentage of participants
|
Adverse Events
All Participants
Serious events: 12 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=54 participants at risk
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Labyrinthitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Lower gastrointestinal (GI) Bleed
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Cardiac disorders
Heart failure
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Lung infection
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
Other adverse events
| Measure |
All Participants
n=54 participants at risk
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)
Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.6%
3/54 • Number of events 7 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Psychiatric disorders
Agitation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
25.9%
14/54 • Number of events 46 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
27.8%
15/54 • Number of events 27 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Immune system disorders
Anaphylaxis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
29.6%
16/54 • Number of events 59 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Psychiatric disorders
Anxiety
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
4/54 • Number of events 7 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
10/54 • Number of events 23 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
8/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Bloating
|
20.4%
11/54 • Number of events 11 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Blood bilirubin increased
|
13.0%
7/54 • Number of events 26 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Eye disorders
Blurred vision
|
13.0%
7/54 • Number of events 7 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
CPK increased
|
11.1%
6/54 • Number of events 8 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Eye disorders
Cataract
|
3.7%
2/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Chills
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
38.9%
21/54 • Number of events 26 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.4%
11/54 • Number of events 13 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Creatinine increased
|
18.5%
10/54 • Number of events 29 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Psychiatric disorders
Depression
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
53.7%
29/54 • Number of events 55 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Dizziness
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
27.8%
15/54 • Number of events 15 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.9%
14/54 • Number of events 17 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Edema limbs
|
27.8%
15/54 • Number of events 23 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Eye disorders
Eye disorders - Other, Stye-right upper lid
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Fatigue
|
59.3%
32/54 • Number of events 45 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Fever
|
18.5%
10/54 • Number of events 12 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Eye disorders
Floaters
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Flu like symptoms
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
31.5%
17/54 • Number of events 18 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Haptoglobin decreased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Headache
|
20.4%
11/54 • Number of events 16 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Cardiac disorders
Heart failure
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Renal and urinary disorders
Hematuria
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
3/54 • Number of events 13 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.3%
5/54 • Number of events 14 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
13.0%
7/54 • Number of events 7 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
18.5%
10/54 • Number of events 22 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Vascular disorders
Hypertension
|
16.7%
9/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.4%
4/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.9%
14/54 • Number of events 43 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
3/54 • Number of events 14 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
6/54 • Number of events 9 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
6/54 • Number of events 16 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
3/54 • Number of events 8 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.4%
11/54 • Number of events 19 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Blood
|
1.9%
1/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, COVID-19
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Herpes Simplex Virus (Shingles)
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Tick bite
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, nausea and vomiting for one time with diarrhea
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Infusion related reaction
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Infusion site extravasation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Injection site reaction
|
24.1%
13/54 • Number of events 22 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Psychiatric disorders
Insomnia
|
35.2%
19/54 • Number of events 22 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.7%
2/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Reproductive system and breast disorders
Libido decreased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Localized edema
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Lung infection
|
18.5%
10/54 • Number of events 10 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
18/54 • Number of events 144 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Lymphocyte count increased
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Malaise
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Memory impairment
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Fasciculation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, muscle cramp, right calf -intermittent
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
18/54 • Number of events 21 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
18/54 • Number of events 22 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, BCC
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Basal cell carcinoma
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Liver and pancreas
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Skin cancer
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Nervous system disorders - Other, Myokimia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Neuralgia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Neutrophil count decreased
|
33.3%
18/54 • Number of events 77 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Eye disorders
Optic nerve disorder
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Ear and labyrinth disorders
Otitis media
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
General disorders
Pain
|
13.0%
7/54 • Number of events 8 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Cardiac disorders
Palpitations
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Paresthesia
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Paronychia
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
12/54 • Number of events 19 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Vascular disorders
Phlebitis
|
20.4%
11/54 • Number of events 14 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Platelet count decreased
|
35.2%
19/54 • Number of events 73 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Presyncope
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.4%
11/54 • Number of events 12 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
64.8%
35/54 • Number of events 55 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Bronchitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Infiltrate
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Rhinitis infective
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Sinusitis
|
9.3%
5/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Basal Cell Carcinoma
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Right knee Cellulitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin nodules
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Nodules
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Skin infection
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Soft tissue infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.4%
4/54 • Number of events 4 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Spasticity
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
20.4%
11/54 • Number of events 11 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Tremor
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
25.9%
14/54 • Number of events 18 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
7.4%
4/54 • Number of events 5 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Number of events 3 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
Weight loss
|
3.7%
2/54 • Number of events 2 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Investigations
White blood cell decreased
|
33.3%
18/54 • Number of events 97 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • Number of events 1 • Date treatment consent signed to date off study, approximately 117 months and 1 day.
54/55 participants are evaluable for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place