Trial Outcomes & Findings for Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood (NCT NCT00923910)
NCT ID: NCT00923910
Last Updated: 2017-04-12
Results Overview
Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
21 months
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
Donors
Period 1 -Donor lymphocyte collection via apheresis. Period 2 -Donor cell processing for vaccine and infusion.
|
Recipients
Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
|
|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
|
Period 1
COMPLETED
|
5
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
5
|
5
|
|
Period 2
COMPLETED
|
5
|
5
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donors were not evaluated.
Baseline characteristics by cohort
| Measure |
Donors
n=5 Participants
Donor lymphocyte collection via apheresis.
|
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
21 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
17 years
STANDARD_DEVIATION 3.71 • n=5 Participants
|
19 years
STANDARD_DEVIATION 8.72 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=5 Participants
|
10 participants
n=10 Participants
|
|
Disease
Hodgkin
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Disease
ALL
|
—
|
3 participants
n=5 Participants • Donors were not evaluated.
|
3 participants
n=5 Participants • Donors were not evaluated.
|
|
Disease
AML
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Transplantation Type
NMA
|
—
|
2 participants
n=5 Participants • Donors were not evaluated.
|
2 participants
n=5 Participants • Donors were not evaluated.
|
|
Transplantation Type
MA
|
—
|
2 participants
n=5 Participants • Donors were not evaluated.
|
2 participants
n=5 Participants • Donors were not evaluated.
|
|
Transplantation Type
MA x 2
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Donors
MSD
|
3 participants
n=5 Participants • Recipients were not evaluated.
|
—
|
3 participants
n=5 Participants • Recipients were not evaluated.
|
|
Donors
MRD*
|
1 participants
n=5 Participants • Recipients were not evaluated.
|
—
|
1 participants
n=5 Participants • Recipients were not evaluated.
|
|
Donors
MUD
|
1 participants
n=5 Participants • Recipients were not evaluated.
|
—
|
1 participants
n=5 Participants • Recipients were not evaluated.
|
|
Conditioning Regimen
Fludarabine/cyclophosphamide
|
—
|
2 participants
n=5 Participants • Donors were not evaluated.
|
2 participants
n=5 Participants • Donors were not evaluated.
|
|
Conditioning Regimen
Cyclophosphamide, TBI, thiotepa
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Conditioning Regimen
HSCT1:cyclo,TBI;HSCT2:busulfan, melphalan, etop
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Conditioning Regimen
Cyclophosphamide, TBI
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Immunosuppression
Cyclosporine
|
—
|
3 participants
n=5 Participants • Donors were not evaluated.
|
3 participants
n=5 Participants • Donors were not evaluated.
|
|
Immunosuppression
Sirolimus/tacrolimus, methotrexate
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Immunosuppression
None after second BMT
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Time Off Immunosuppression before Protocol Enrollment
Patient 1
|
—
|
10 Months
n=5 Participants • Donors were not evaluated.
|
10 Months
n=5 Participants • Donors were not evaluated.
|
|
Time Off Immunosuppression before Protocol Enrollment
Patient 2
|
—
|
28 Months
n=5 Participants • Donors were not evaluated.
|
28 Months
n=5 Participants • Donors were not evaluated.
|
|
Time Off Immunosuppression before Protocol Enrollment
Patient 3
|
—
|
11 Months
n=5 Participants • Donors were not evaluated.
|
11 Months
n=5 Participants • Donors were not evaluated.
|
|
Time Off Immunosuppression before Protocol Enrollment
Patient 4
|
—
|
23 Months
n=5 Participants • Donors were not evaluated.
|
23 Months
n=5 Participants • Donors were not evaluated.
|
|
Time Off Immunosuppression before Protocol Enrollment
Patient 5
|
—
|
9 Months
n=5 Participants • Donors were not evaluated.
|
9 Months
n=5 Participants • Donors were not evaluated.
|
|
Pre-Enrollment Disease Status
6%-8% blasts
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Pre-Enrollment Disease Status
Multiple 1-2cm lymph nodes
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Pre-Enrollment Disease Status
5%-10% blasts
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Pre-Enrollment Disease Status
2% blasts
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Pre-Enrollment Disease Status
5% blasts
|
—
|
1 participants
n=5 Participants • Donors were not evaluated.
|
1 participants
n=5 Participants • Donors were not evaluated.
|
|
Time to HCT to Relapse, mo
Patient 1
|
—
|
8 Months
n=5 Participants • Donors were not evaluated.
|
8 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to HCT to Relapse, mo
Patient 2
|
—
|
1 Months
n=5 Participants • Donors were not evaluated.
|
1 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to HCT to Relapse, mo
Patient 3
|
—
|
12 Months
n=5 Participants • Donors were not evaluated.
|
12 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to HCT to Relapse, mo
Patient 4
|
—
|
11 Months
n=5 Participants • Donors were not evaluated.
|
11 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to HCT to Relapse, mo
Patient 5
|
—
|
12 Months
n=5 Participants • Donors were not evaluated.
|
12 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to First Vaccine (from day 0 of HCT), mo
Patient 1
|
—
|
14 Months
n=5 Participants • Donors were not evaluated.
|
14 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to First Vaccine (from day 0 of HCT), mo
Patient 2
|
—
|
32 Months
n=5 Participants • Donors were not evaluated.
|
32 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to First Vaccine (from day 0 of HCT), mo
Patient 3
|
—
|
14 Months
n=5 Participants • Donors were not evaluated.
|
14 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to First Vaccine (from day 0 of HCT), mo
Patient 4
|
—
|
29 Months
n=5 Participants • Donors were not evaluated.
|
29 Months
n=5 Participants • Donors were not evaluated.
|
|
Time to First Vaccine (from day 0 of HCT), mo
Patient 5
|
—
|
15 Months
n=5 Participants • Donors were not evaluated.
|
15 Months
n=5 Participants • Donors were not evaluated.
|
PRIMARY outcome
Timeframe: 21 monthsPopulation: Only recipients were monitored for adverse events.
Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Toxicity
|
5 participants
|
PRIMARY outcome
Timeframe: 28 days following completion of last vaccine and/or DLI (donor lymphocyte infusion) administrationPopulation: Data for the frequency and severity of GVHD was captured as an endpoint for this trial. The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.
Acute Graft versus Host Disease (GVHD) was graded by the modified Glucksberg scale. 0 = no GVHD normal, 4 = severe GVHD.
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3
|
0 participants
|
SECONDARY outcome
Timeframe: 4 to 12 weeksPopulation: The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.
Immune response was monitored by use of interferon gamma Enzyme-Linked Immunospot (ELISpot) and by delayed-type hypersensitivity (DTH) testing.
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Time to Immune Response
Patient 1
|
12 Weeks
|
|
Time to Immune Response
Patient 2
|
NA Weeks
Not collected.
|
|
Time to Immune Response
Patient 3
|
8 Weeks
|
|
Time to Immune Response
Patient 4
|
4 Weeks
|
|
Time to Immune Response
Patient 5
|
3 Weeks
|
SECONDARY outcome
Timeframe: 48 to 72 hours after placementPopulation: The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.
WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control.
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)
Negative
|
2 participants
|
|
Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)
Positive
|
3 participants
|
SECONDARY outcome
Timeframe: 48 to 72 hours after placementPopulation: The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.
WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)
Positive
|
2 participants
|
|
Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)
Negative
|
2 participants
|
|
Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)
NA (Not available)
|
1 participants
|
SECONDARY outcome
Timeframe: 48 to 72 hours after placementPopulation: The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.
KLH is a neoantigen known to induce helper response was used concurrently as a vaccine adjuvant and control antigen. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)
Positive
|
3 participants
|
|
Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)
Negative
|
1 participants
|
|
Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)
NA (Not available)
|
1 participants
|
SECONDARY outcome
Timeframe: 4 to12 weeksPopulation: The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.
Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions (i.e. tumor response). Response criteria for acute leukemia's is worse marrow classification (i.e., M status) with at least a 50% increase in the percentage of marrow blasts, or no change in marrow classification (i.e., M status), but a 50% or greater increase in absolute peripheral blast count or extent of medullary disease
Outcome measures
| Measure |
Recipients
n=5 Participants
Vaccine and donor lymphocyte prep
|
|---|---|
|
Number of Participants With Progressive Disease
|
5 participants
|
Adverse Events
Recipients
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recipients
n=5 participants at risk
Vaccine and donor lymphocyte prep
|
|---|---|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase) - high
|
60.0%
3/5 • Number of events 6 • 21 months
Only recipients were monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Cardiac disorders
Hypotension
|
20.0%
1/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Immune system disorders
Allergy/Immunology - Other, Specify - allergy to Sorbaview
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
Coagulation - Other, Specify - PT, prolonged
|
20.0%
1/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Glucose (serum -high (hyperglycemia)
|
40.0%
2/5 • Number of events 25 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
80.0%
4/5 • Number of events 7 • 21 months
Only recipients were monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum low
|
40.0%
2/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Albumin, serum low (hypoalbuminemia)
|
40.0%
2/5 • Number of events 19 • 21 months
Only recipients were monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Eye disorders
Dry eye syndrome
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Gastrointestinal disorders
Esophagitis
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
|
60.0%
3/5 • Number of events 5 • 21 months
Only recipients were monitored for adverse events.
|
|
Infections and infestations
Febrile neutropenia
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
General disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
Iron overload
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Magnesium, serum high (hypermagnesemia)
|
40.0%
2/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Magnesium, serum low (hypomagnesemia)
|
40.0%
2/5 • Number of events 7 • 21 months
Only recipients were monitored for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Eye disorders
Ocular/Visual - Other, Specify - Eye drainage
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
60.0%
3/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Eye disorders
Pain: Eye
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Nervous system disorders
Pain: Head/Headache
|
40.0%
2/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain:Joint
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
80.0%
4/5 • Number of events 11 • 21 months
Only recipients were monitored for adverse events.
|
|
General disorders
Rigors/chills
|
20.0%
1/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Striae
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: sinus bradycardia
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: sinus tachycardia
|
40.0%
2/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
General disorders
Sweating (diaphoresis)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Triglyceride, serum high (hypertriglyceridemia)
|
20.0%
1/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Uric acid, serum high (hyperuricemia)
|
20.0%
1/5 • Number of events 4 • 21 months
Only recipients were monitored for adverse events.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Eye disorders
Vision-blurred vision
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
Platelets-low
|
100.0%
5/5 • Number of events 30 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
20.0%
1/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Phosphate, serum low (hypophosphatemia)
|
20.0%
1/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pain: chest wall
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain: neck
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Nervous system disorders
Mood alteration:anxiety
|
40.0%
2/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pain: throat/pharynx/larynx
|
40.0%
2/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) - low
|
80.0%
4/5 • Number of events 26 • 21 months
Only recipients were monitored for adverse events.
|
|
Infections and infestations
Infection with unknown ANC:sinus
|
20.0%
1/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
PTT (partial thromboplastin time)
|
40.0%
2/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
80.0%
4/5 • Number of events 7 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase) - high
|
60.0%
3/5 • Number of events 12 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
20.0%
1/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
40.0%
2/5 • Number of events 18 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin-low
|
80.0%
4/5 • Number of events 14 • 21 months
Only recipients were monitored for adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) - low
|
80.0%
4/5 • Number of events 21 • 21 months
Only recipients were monitored for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain:muscle
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
General disorders
Pain:pain NOS
|
20.0%
1/5 • Number of events 3 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
40.0%
2/5 • Number of events 9 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Proteinuria
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
20.0%
1/5 • Number of events 1 • 21 months
Only recipients were monitored for adverse events.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
60.0%
3/5 • Number of events 6 • 21 months
Only recipients were monitored for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place