Trial Outcomes & Findings for Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma (NCT NCT02098109)
NCT ID: NCT02098109
Last Updated: 2017-07-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Day 5
Results posted on
2017-07-18
Participant Flow
The study opened to participant enrollment on 08/20/2014 and closed to participant enrollment on 06/14/2016.
Participant milestones
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
46
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
Baseline Characteristics
Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
51 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Prior Therapies
|
1.5 number of prior therapies
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.4 number of prior therapies
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.5 number of prior therapies
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Diagnosis
Multiple myeloma
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Diagnosis
Non-Hodgkin's Lymphoma
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Prior Radiation
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
|
11.6 cells/kg
Standard Deviation 6.7
|
10.0 cells/kg
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Up to 20 days after last apheresis (Day 25-Day 28)-Adverse events will be assessed using CTCAE version 4.0
Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Thrombocytopenia
|
18 participants
|
20 participants
|
|
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Bone pain
|
19 participants
|
22 participants
|
|
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Anemia
|
13 participants
|
18 participants
|
|
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Alkaline phosphatase increased
|
10 participants
|
12 participants
|
|
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Nausea and/or vomiting
|
10 participants
|
10 participants
|
|
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Leukocytosis
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Up to Day 30 post-infusionPopulation: (2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.
Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.
Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=44 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=50 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
|
11 days
Interval 11.0 to 12.0
|
11.5 days
Interval 11.0 to 12.0
|
SECONDARY outcome
Timeframe: Up to Day 100Population: (2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.
Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.
Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=44 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=50 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Time to Platelet Engraftment Between the Two Arms
|
18 days
Interval 16.0 to 21.0
|
17.5 days
Interval 16.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to Day 100Population: (2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.
Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse
Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=44 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=50 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Readmission Rate Between the Two Arms
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Day 8 (total collection)Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 8 (total collection)Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
|
96 percentage of participants
|
96 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
|
98 percentage of participants
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Outcome measures
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 Participants
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 Participants
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
|
83 percentage of participants
|
76 percentage of participants
|
Adverse Events
XM02 Filgrastim (Granix) and Plerixafor
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Filgrastim (Neupogen) and Plerixafor
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 participants at risk
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 participants at risk
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46
|
0.00%
0/51
|
|
General disorders
Edema - limbs
|
0.00%
0/46
|
2.0%
1/51
|
|
General disorders
Pain
|
0.00%
0/46
|
2.0%
1/51
|
|
Infections and infestations
Central line site cellulitis
|
0.00%
0/46
|
2.0%
1/51
|
|
Psychiatric disorders
Panic attack
|
2.2%
1/46
|
0.00%
0/51
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46
|
0.00%
0/51
|
|
Vascular disorders
Hypotension
|
0.00%
0/46
|
2.0%
1/51
|
Other adverse events
| Measure |
XM02 Filgrastim (Granix) and Plerixafor
n=46 participants at risk
XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
Filgrastim (Neupogen) and Plerixafor
n=51 participants at risk
Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.3%
13/46
|
35.3%
18/51
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/46
|
2.0%
1/51
|
|
Blood and lymphatic system disorders
Leukocytosis
|
17.4%
8/46
|
19.6%
10/51
|
|
Cardiac disorders
Palpitations
|
4.3%
2/46
|
0.00%
0/51
|
|
Eye disorders
Scleral disorder
|
0.00%
0/46
|
2.0%
1/51
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/46
|
5.9%
3/51
|
|
Gastrointestinal disorders
Bloating
|
2.2%
1/46
|
0.00%
0/51
|
|
Gastrointestinal disorders
Constipation
|
8.7%
4/46
|
5.9%
3/51
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46
|
11.8%
6/51
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/46
|
0.00%
0/51
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46
|
0.00%
0/51
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/46
|
0.00%
0/51
|
|
Gastrointestinal disorders
Nausea
|
19.6%
9/46
|
15.7%
8/51
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.2%
1/46
|
2.0%
1/51
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46
|
7.8%
4/51
|
|
General disorders
Chills
|
2.2%
1/46
|
9.8%
5/51
|
|
General disorders
Edema - limbs
|
2.2%
1/46
|
7.8%
4/51
|
|
General disorders
Fatigue
|
0.00%
0/46
|
5.9%
3/51
|
|
General disorders
Fever
|
0.00%
0/46
|
3.9%
2/51
|
|
General disorders
Injection site reaction
|
0.00%
0/46
|
3.9%
2/51
|
|
General disorders
Non-cardiac chest pain
|
4.3%
2/46
|
3.9%
2/51
|
|
General disorders
Pain
|
2.2%
1/46
|
0.00%
0/51
|
|
General disorders
Pain at biopsy site
|
2.2%
1/46
|
0.00%
0/51
|
|
General disorders
Pain at catheter site
|
2.2%
1/46
|
0.00%
0/51
|
|
Infections and infestations
Cellulitis
|
0.00%
0/46
|
2.0%
1/51
|
|
Infections and infestations
Rhinovirus positive culture
|
0.00%
0/46
|
2.0%
1/51
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/46
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Bleeding at catheter site
|
10.9%
5/46
|
7.8%
4/51
|
|
Injury, poisoning and procedural complications
Bruising
|
2.2%
1/46
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Discharge at catheter
|
2.2%
1/46
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Drainage at catheter
|
0.00%
0/46
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Erythema at catheter site
|
2.2%
1/46
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Pain at catheter site
|
2.2%
1/46
|
0.00%
0/51
|
|
Investigations
Activated partial thromboplastin time prolonged
|
17.4%
8/46
|
7.8%
4/51
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
2/46
|
2.0%
1/51
|
|
Investigations
Alkaline phosphatase increased
|
21.7%
10/46
|
23.5%
12/51
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
2/46
|
2.0%
1/51
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/46
|
2.0%
1/51
|
|
Investigations
Creatinine increased
|
6.5%
3/46
|
2.0%
1/51
|
|
Investigations
INR increased
|
15.2%
7/46
|
7.8%
4/51
|
|
Investigations
Lymphocyte count decreased
|
39.1%
18/46
|
41.2%
21/51
|
|
Investigations
Lymphocyte count increased
|
32.6%
15/46
|
19.6%
10/51
|
|
Investigations
Neutrophil count decreased
|
6.5%
3/46
|
2.0%
1/51
|
|
Investigations
Platelet count decreased
|
39.1%
18/46
|
39.2%
20/51
|
|
Investigations
Weight loss
|
0.00%
0/46
|
2.0%
1/51
|
|
Investigations
White blood cell decreased
|
10.9%
5/46
|
5.9%
3/51
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/46
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/46
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/46
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/46
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
1/46
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.7%
4/46
|
5.9%
3/51
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.5%
3/46
|
7.8%
4/51
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.2%
1/46
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
2/46
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
3/46
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
1/46
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/46
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.5%
3/46
|
3.9%
2/51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
7/46
|
11.8%
6/51
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/46
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
41.3%
19/46
|
43.1%
22/51
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
1/46
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Hand cramping
|
0.00%
0/46
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/46
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/46
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
2/46
|
3.9%
2/51
|
|
Nervous system disorders
Dizziness
|
6.5%
3/46
|
9.8%
5/51
|
|
Nervous system disorders
Headache
|
6.5%
3/46
|
7.8%
4/51
|
|
Nervous system disorders
Hypersomnia
|
2.2%
1/46
|
0.00%
0/51
|
|
Nervous system disorders
Movements involuntary
|
2.2%
1/46
|
0.00%
0/51
|
|
Nervous system disorders
Neuralgia
|
2.2%
1/46
|
0.00%
0/51
|
|
Nervous system disorders
Numbness of face
|
0.00%
0/46
|
2.0%
1/51
|
|
Nervous system disorders
Paresthesia
|
13.0%
6/46
|
7.8%
4/51
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
1/46
|
3.9%
2/51
|
|
Nervous system disorders
Tremor
|
2.2%
1/46
|
0.00%
0/51
|
|
Psychiatric disorders
Anxiety
|
15.2%
7/46
|
5.9%
3/51
|
|
Psychiatric disorders
Confusion
|
2.2%
1/46
|
2.0%
1/51
|
|
Psychiatric disorders
Depression
|
2.2%
1/46
|
0.00%
0/51
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/46
|
2.0%
1/51
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/46
|
0.00%
0/51
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46
|
0.00%
0/51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.9%
5/46
|
7.8%
4/51
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/46
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.2%
1/46
|
0.00%
0/51
|
|
Skin and subcutaneous tissue disorders
Fever blister
|
2.2%
1/46
|
0.00%
0/51
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/46
|
0.00%
0/51
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.00%
0/46
|
2.0%
1/51
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46
|
2.0%
1/51
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.2%
1/46
|
0.00%
0/51
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
1/46
|
2.0%
1/51
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.2%
1/46
|
0.00%
0/51
|
|
Vascular disorders
Hypertension
|
2.2%
1/46
|
3.9%
2/51
|
|
Vascular disorders
Hypotension
|
8.7%
4/46
|
3.9%
2/51
|
Additional Information
Camille Abboud, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place