Trial Outcomes & Findings for Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies (NCT NCT00914849)
NCT ID: NCT00914849
Last Updated: 2017-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Completion of enrollment of all donors (17 months)
Results posted on
2017-05-17
Participant Flow
The study opened to participant enrollment on 08/12/2009 and closed to participants enrollment on 01/31/2011.
Participant milestones
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg intravenous (IV)
* Leukopheresis
* Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg intravenous (IV)
* Leukopheresis
* Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Not eligible
|
0
|
1
|
Baseline Characteristics
Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Arm 1 - Donor
n=34 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
54 years
n=107 Participants
|
52 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
33 participants
n=107 Participants
|
67 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Completion of enrollment of all donors (17 months)Population: 3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection.
Outcome measures
| Measure |
Arm 1 - Donor
n=29 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 2Outcome measures
| Measure |
Arm 1 - Donor
n=34 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Number of Donors Who Experience Grade 3-4 Infusional Toxicity
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 21Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Number of Recipients Who Have Neutrophil Engraftment
|
—
|
33 participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 2-Blood samples for pharmacokinetics were drawn on the following schedule: * prior to IV infusion * 15 minutes after start of infusion * 30 minutes after start of infusion * 1 hour after start of infusion * 4 hours after start of infusion * 6 hours after start of infusion * 9 hours after start of infusion * 24 hours after start of infusion
Outcome measures
| Measure |
Arm 1 - Donor
n=34 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)
|
1391 ng/mL
Standard Deviation 488
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2-Blood samples for pharmacokinetics were drawn on the following schedule: * prior to IV infusion * 15 minutes after start of infusion * 30 minutes after start of infusion * 1 hour after start of infusion * 4 hours after start of infusion * 6 hours after start of infusion * 9 hours after start of infusion * 24 hours after start of infusion
Outcome measures
| Measure |
Arm 1 - Donor
n=34 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Pharmacokinetics of IV AMD3100 as Measured by Half Life
|
5.42 hours
Standard Deviation 1.24
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Outcome measures
| Measure |
Arm 1 - Donor
n=34 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)
|
5049 hr.ng/mL
Standard Deviation 1233
|
—
|
SECONDARY outcome
Timeframe: Day 0-Day 100 (acute)Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Rate of Acute GVHD (Grade II-IV) in Recipients
|
—
|
4 participants
|
SECONDARY outcome
Timeframe: Day 0-Day 100 (acute)Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Rate of Acute GVHD (Grade III-IV) in Recipients
|
—
|
4 participants
|
SECONDARY outcome
Timeframe: Up through Day 100Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.
Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Time to Neutrophil Engraftment for Recipients
|
—
|
14 days
Interval 11.0 to 24.0
|
SECONDARY outcome
Timeframe: Up to Day 100Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.
Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Time to Platelet Engraftment for Recipients
|
—
|
25 days
Interval 15.0 to 219.0
|
SECONDARY outcome
Timeframe: Day 100Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.
Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Transplant Related Mortality Rate for Recipients
|
—
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearAssessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.
Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=34 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Grade 3-4 Toxicity for Recipients
Grade 3 fatigue
|
—
|
3 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 thrombocytopenia
|
—
|
1 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 mucositis
|
—
|
5 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 GI fistula
|
—
|
1 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 increased transaminase
|
—
|
2 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 febrile neutropenia
|
—
|
32 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 bacteremia+
|
—
|
4 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 respiratory distress
|
—
|
1 participants
|
|
Grade 3-4 Toxicity for Recipients
Grade 3 renal failure
|
—
|
6 participants
|
SECONDARY outcome
Timeframe: Day 101-1 yearPopulation: 8 patients are not evaluable because they were not alive for the outcome measure time frame.
Outcome measures
| Measure |
Arm 1 - Donor
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=25 Participants
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Rate of Chronic GVHD in Recipients
|
—
|
7 participants
|
SECONDARY outcome
Timeframe: Up to Day 2Outcome measures
| Measure |
Arm 1 - Donor
n=34 Participants
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure
|
2 participants
|
—
|
Adverse Events
Arm 1 - Donor
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Arm 2 - Recipient
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - Donor
n=33 participants at risk
* Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if PBSC collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis
|
Arm 2 - Recipient
n=33 participants at risk
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
51.5%
17/33
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress
|
0.00%
0/33
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/33
|
9.1%
3/33
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
39.4%
13/33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33
|
9.1%
3/33
|
|
Infections and infestations
Bacteremia
|
0.00%
0/33
|
12.1%
4/33
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/33
|
9.1%
3/33
|
|
General disorders
Catheter site pain
|
0.00%
0/33
|
15.2%
5/33
|
|
Cardiac disorders
Chest pain
|
6.1%
2/33
|
0.00%
0/33
|
|
General disorders
Cold sensation
|
9.1%
3/33
|
0.00%
0/33
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/33
|
3.0%
1/33
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33
|
24.2%
8/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33
|
6.1%
2/33
|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
12/33
|
48.5%
16/33
|
|
Gastrointestinal disorders
Distension/abdominal bloating
|
30.3%
10/33
|
18.2%
6/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
3/33
|
27.3%
9/33
|
|
General disorders
Fatigue
|
0.00%
0/33
|
39.4%
13/33
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/33
|
97.0%
32/33
|
|
General disorders
Fever
|
0.00%
0/33
|
6.1%
2/33
|
|
Gastrointestinal disorders
GI fistula
|
0.00%
0/33
|
3.0%
1/33
|
|
General disorders
Generalized weakness
|
0.00%
0/33
|
90.9%
30/33
|
|
Psychiatric disorders
Hand tremor
|
0.00%
0/33
|
3.0%
1/33
|
|
Nervous system disorders
Headache
|
6.1%
2/33
|
21.2%
7/33
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/33
|
3.0%
1/33
|
|
Vascular disorders
Hot flashes
|
0.00%
0/33
|
6.1%
2/33
|
|
Investigations
Hyperbiluribinemia
|
0.00%
0/33
|
21.2%
7/33
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/33
|
12.1%
4/33
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/33
|
42.4%
14/33
|
|
Vascular disorders
Hypertension
|
0.00%
0/33
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
72.7%
24/33
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/33
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/33
|
24.2%
8/33
|
|
Vascular disorders
Hypotension
|
21.2%
7/33
|
9.1%
3/33
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/33
|
3.0%
1/33
|
|
Investigations
Increase transaminase
|
0.00%
0/33
|
24.2%
8/33
|
|
Psychiatric disorders
Insomnia
|
12.1%
4/33
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/33
|
9.1%
3/33
|
|
Nervous system disorders
Lightheadedness
|
15.2%
5/33
|
0.00%
0/33
|
|
General disorders
Lower extremities edema
|
0.00%
0/33
|
39.4%
13/33
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/33
|
6.1%
2/33
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/33
|
54.5%
18/33
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/33
|
3.0%
1/33
|
|
Gastrointestinal disorders
Nausea
|
21.2%
7/33
|
39.4%
13/33
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/33
|
3.0%
1/33
|
|
Infections and infestations
Parotiditis
|
0.00%
0/33
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/33
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33
|
3.0%
1/33
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/33
|
18.2%
6/33
|
|
Nervous system disorders
Sensory neuropathy
|
69.7%
23/33
|
0.00%
0/33
|
|
Cardiac disorders
Sinus bradycardia
|
24.2%
8/33
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Skin nodules
|
0.00%
0/33
|
3.0%
1/33
|
|
General disorders
Sweating (diaphoresis)
|
15.2%
5/33
|
0.00%
0/33
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/33
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.00%
0/33
|
15.2%
5/33
|
|
Investigations
Thrombocytopenia
|
12.1%
4/33
|
6.1%
2/33
|
|
Vascular disorders
Thrombosis/embolism (DVT)
|
0.00%
0/33
|
3.0%
1/33
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/33
|
9.1%
3/33
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/33
|
3.0%
1/33
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33
|
3.0%
1/33
|
|
Nervous system disorders
Vasovagal episode
|
18.2%
6/33
|
0.00%
0/33
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33
|
36.4%
12/33
|
|
General disorders
Warm sensation
|
3.0%
1/33
|
0.00%
0/33
|
|
Investigations
Weight loss
|
0.00%
0/33
|
9.1%
3/33
|
Additional Information
John DiPersio, M.D., Ph.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