Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer (NCT NCT00818961)
NCT ID: NCT00818961
Last Updated: 2013-12-18
Results Overview
Survival at Day 100
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
100 day
Results posted on
2013-12-18
Participant Flow
The first patient on this study was enrolled \& transplanted on 6/9/05. The last patient on this study was enrolled \& transplanted on 1/5/11.
No "groups" were assigned. Pts received chemotherapy based on their disease. 39 patients consented to study but 36 patients received protocol treatment. 3 patients were considered screen failures and did not move forward on study.
Participant milestones
| Measure |
Hematopoietic Stem Cell Transplantation
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
56.44 years
STANDARD_DEVIATION 6.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 dayPopulation: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at 100 days
Survival at Day 100
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Survival at Day 100
|
35 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at one year post-transplant
Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant)
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Overall Survival at 1 Year
|
26 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of non-relapse mortality at Day 100
patients are evaluable for their cause of death at Day 100
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Non-relapse Mortality at Day 100
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 36 patients underwent hematopoietic stem cell transplant. 10 patients died prior to 1 year post-transplant and were eligible for evaluation of non-relapse mortality at 1 year post-transplant
Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive.
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Non-relapse Mortality at 1 Year Post-transplant
|
4 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of donor chimerism
Complete donor chimerism (defined as \>/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured.
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Complete Donor Chimerism
|
26 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of neutrophil recovery
The number of patients experiencing neutrophil recovery post transplant
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Neutrophil Recovery
|
35 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of platelet engraftment.
The number of patients experiencing platelet engraftment post-transplant
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Platelet Engraftment
|
35 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for donor leukocyte infusions for mixed chimerism following transplant
DLI is used for patients with mixed chimerism following transplant
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism
|
19 participants
|
SECONDARY outcome
Timeframe: patients were followed for 2 yearsPopulation: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of acute graft versus host disease post-transplant.
patients experiencing acute graft versus host disease post-transplant
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant
|
15 participants
|
SECONDARY outcome
Timeframe: >100 days post-transplantPopulation: 35 patients survive past 100 days post-transplant and therefore were eligible for evaluation of chronic graft versus host disease
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=35 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Number of Patients Experiencing Chronic Graft Versus Host Disease
|
20 participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of VOD post-transplant
Patients will be evaluated up to 4 years post transplant
Outcome measures
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 Participants
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
|
|---|---|
|
Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant
|
0 participants
|
Adverse Events
Hematopoietic Stem Cell Transplantation
Serious events: 10 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 participants at risk
All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
|
|---|---|
|
Nervous system disorders
Syncopal Episode
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
cerebral venous thrombosis and hemorrhage
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
aortic valve endocarditis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
pulmonary/upper respiratory chest pain
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
progressive non-oliguric renal failure
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
norovirus
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
thrombosis/embolism
|
2.8%
1/36 • Number of events 1
|
Other adverse events
| Measure |
Hematopoietic Stem Cell Transplantation
n=36 participants at risk
All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
|
|---|---|
|
Gastrointestinal disorders
abdominal cramping
|
33.3%
12/36 • Number of events 12
|
|
Gastrointestinal disorders
abdominal discomfort/tenderness
|
25.0%
9/36 • Number of events 9
|
|
General disorders
abdominal distention
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
abdominal pain
|
44.4%
16/36 • Number of events 16
|
|
Psychiatric disorders
aggitation
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Alkaline Phosphatase
|
61.1%
22/36 • Number of events 22
|
|
Hepatobiliary disorders
ALT
|
72.2%
26/36 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
anal/rectal erythema
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
ANC
|
80.6%
29/36 • Number of events 29
|
|
Blood and lymphatic system disorders
anemia
|
75.0%
27/36 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
ankle pain
|
19.4%
7/36 • Number of events 7
|
|
Metabolism and nutrition disorders
anorexia
|
41.7%
15/36 • Number of events 15
|
|
Psychiatric disorders
anxiety
|
69.4%
25/36 • Number of events 25
|
|
Hepatobiliary disorders
AST
|
83.3%
30/36 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
back pain
|
25.0%
9/36 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
basilar crackles
|
5.6%
2/36 • Number of events 2
|
|
Renal and urinary disorders
BK virus
|
16.7%
6/36 • Number of events 6
|
|
Gastrointestinal disorders
bloody stool
|
5.6%
2/36 • Number of events 2
|
|
Eye disorders
blurry vision
|
13.9%
5/36 • Number of events 5
|
|
Reproductive system and breast disorders
BPH
|
5.6%
2/36 • Number of events 2
|
|
Cardiac disorders
bradycardi
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
bruising
|
27.8%
10/36 • Number of events 10
|
|
Infections and infestations
C diff
|
11.1%
4/36 • Number of events 4
|
|
General disorders
chest pain
|
19.4%
7/36 • Number of events 7
|
|
General disorders
chest tightness
|
16.7%
6/36 • Number of events 6
|
|
Investigations
chills
|
50.0%
18/36 • Number of events 18
|
|
Gastrointestinal disorders
cholecystitis
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
citrobacteria infection
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
CMV
|
50.0%
18/36 • Number of events 18
|
|
Psychiatric disorders
confusion
|
16.7%
6/36 • Number of events 6
|
|
Eye disorders
conjunctivitis
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
41.7%
15/36 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
69.4%
25/36 • Number of events 25
|
|
Metabolism and nutrition disorders
increased creatinine
|
80.6%
29/36 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
CVC drainage
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
CVC pain/tenderness
|
16.7%
6/36 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
deconditioned
|
8.3%
3/36 • Number of events 3
|
|
Metabolism and nutrition disorders
decreased appetite
|
52.8%
19/36 • Number of events 19
|
|
Metabolism and nutrition disorders
decreased oral intake
|
8.3%
3/36 • Number of events 3
|
|
Metabolism and nutrition disorders
dehydration
|
16.7%
6/36 • Number of events 6
|
|
Psychiatric disorders
depression
|
33.3%
12/36 • Number of events 12
|
|
Metabolism and nutrition disorders
diaphoresis
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
94.4%
34/36 • Number of events 34
|
|
Gastrointestinal disorders
difficulty swallowing
|
16.7%
6/36 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
diminished breath sounds
|
13.9%
5/36 • Number of events 5
|
|
Psychiatric disorders
disoriented
|
8.3%
3/36 • Number of events 3
|
|
General disorders
dizziness/lighheadedness
|
47.2%
17/36 • Number of events 17
|
|
General disorders
drowsiness
|
25.0%
9/36 • Number of events 9
|
|
Eye disorders
dry eyes
|
19.4%
7/36 • Number of events 7
|
|
Gastrointestinal disorders
dry heaves
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
dry mouth
|
22.2%
8/36 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
dry skin
|
30.6%
11/36 • Number of events 11
|
|
Vascular disorders
DVT
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
dyspepsia
|
30.6%
11/36 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
dyspenea on exertion
|
13.9%
5/36 • Number of events 5
|
|
Renal and urinary disorders
dysuria
|
11.1%
4/36 • Number of events 4
|
|
Ear and labyrinth disorders
ear congestion
|
8.3%
3/36 • Number of events 3
|
|
Ear and labyrinth disorders
ear pain
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
eczema
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
edema
|
25.0%
9/36 • Number of events 9
|
|
General disorders
epistaxis
|
33.3%
12/36 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
erythema
|
13.9%
5/36 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
erythema at CVC site
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
esophagitis
|
5.6%
2/36 • Number of events 2
|
|
General disorders
facial drooping
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
facial redness
|
8.3%
3/36 • Number of events 3
|
|
General disorders
facial swelling
|
8.3%
3/36 • Number of events 3
|
|
Injury, poisoning and procedural complications
fall
|
5.6%
2/36 • Number of events 2
|
|
General disorders
fatigue
|
86.1%
31/36 • Number of events 31
|
|
General disorders
feeling "cold"
|
5.6%
2/36 • Number of events 2
|
|
General disorders
fever
|
80.6%
29/36 • Number of events 29
|
|
General disorders
flank pain
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
flat affect
|
11.1%
4/36 • Number of events 4
|
|
Blood and lymphatic system disorders
fluid overload
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
fluid retention
|
5.6%
2/36 • Number of events 2
|
|
General disorders
FLUSHING
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
FOLLICULITIS
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
FUNGAL RASH
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
gas pain
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
gastritis
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
GERD
|
47.2%
17/36 • Number of events 17
|
|
Gastrointestinal disorders
GI distress
|
19.4%
7/36 • Number of events 7
|
|
Immune system disorders
gout
|
8.3%
3/36 • Number of events 3
|
|
Infections and infestations
gram positive bacteremia
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
hallucinations
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
hand foot syndrome
|
8.3%
3/36 • Number of events 3
|
|
General disorders
headache/migraine
|
72.2%
26/36 • Number of events 26
|
|
Renal and urinary disorders
hematuria
|
13.9%
5/36 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
hemorrhoids
|
16.7%
6/36 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
hsv
|
8.3%
3/36 • Number of events 3
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
30.6%
11/36 • Number of events 11
|
|
Metabolism and nutrition disorders
hypercalcemia
|
30.6%
11/36 • Number of events 11
|
|
Metabolism and nutrition disorders
hyperglycemia
|
83.3%
30/36 • Number of events 30
|
|
Metabolism and nutrition disorders
hyperkalemia
|
50.0%
18/36 • Number of events 18
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
19.4%
7/36 • Number of events 7
|
|
Metabolism and nutrition disorders
hypernatremia
|
33.3%
12/36 • Number of events 12
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
5.6%
2/36 • Number of events 2
|
|
Cardiac disorders
hypertension
|
58.3%
21/36 • Number of events 21
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
77.8%
28/36 • Number of events 28
|
|
Metabolism and nutrition disorders
hypocalemia
|
69.4%
25/36 • Number of events 25
|
|
Metabolism and nutrition disorders
hypoglycemia
|
8.3%
3/36 • Number of events 3
|
|
Metabolism and nutrition disorders
hypokalemia
|
63.9%
23/36 • Number of events 23
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
83.3%
30/36 • Number of events 30
|
|
Metabolism and nutrition disorders
hyponatremia
|
69.4%
25/36 • Number of events 25
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
8.3%
3/36 • Number of events 3
|
|
Cardiac disorders
hypotension
|
41.7%
15/36 • Number of events 15
|
|
Endocrine disorders
hypothyroidism
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
22.2%
8/36 • Number of events 8
|
|
Gastrointestinal disorders
incontinent (stool)
|
11.1%
4/36 • Number of events 4
|
|
General disorders
increased thirst
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
insomnia
|
50.0%
18/36 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
leg/knee pain
|
16.7%
6/36 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
limited range of motion
|
5.6%
2/36 • Number of events 2
|
|
General disorders
lip sore
|
5.6%
2/36 • Number of events 2
|
|
General disorders
loss of balance
|
11.1%
4/36 • Number of events 4
|
|
Blood and lymphatic system disorders
lower extremity edema
|
30.6%
11/36 • Number of events 11
|
|
General disorders
malaise
|
11.1%
4/36 • Number of events 4
|
|
Nervous system disorders
memory changes
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
mouth erythema
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
mouth pain/tenderness
|
13.9%
5/36 • Number of events 5
|
|
Infections and infestations
MRSE
|
22.2%
8/36 • Number of events 8
|
|
Gastrointestinal disorders
mucositis
|
58.3%
21/36 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
8.3%
3/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
myalgia/arthralgia
|
25.0%
9/36 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
16.7%
6/36 • Number of events 6
|
|
Gastrointestinal disorders
nausea
|
91.7%
33/36 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
11.1%
4/36 • Number of events 4
|
|
General disorders
neutropenic fever
|
11.1%
4/36 • Number of events 4
|
|
Investigations
night sweats
|
13.9%
5/36 • Number of events 5
|
|
Renal and urinary disorders
nocturia
|
5.6%
2/36 • Number of events 2
|
|
General disorders
pain
|
22.2%
8/36 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
pale skin
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
parainfluenza
|
16.7%
6/36 • Number of events 6
|
|
Eye disorders
periorbital edema
|
8.3%
3/36 • Number of events 3
|
|
Nervous system disorders
peripheral neuropathy
|
30.6%
11/36 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
PICC line erythema
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
platelet reaction
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
pneumonia
|
13.9%
5/36 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
post nasal drip
|
16.7%
6/36 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
pruritis
|
72.2%
26/36 • Number of events 26
|
|
Blood and lymphatic system disorders
PTT
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infiltrates
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary nodules
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
rash
|
72.2%
26/36 • Number of events 26
|
|
Gastrointestinal disorders
rectal bleeding
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
rectal pain/discomfort
|
11.1%
4/36 • Number of events 4
|
|
Renal and urinary disorders
renal failure
|
5.6%
2/36 • Number of events 2
|
|
Renal and urinary disorders
renal insufficiency
|
25.0%
9/36 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
11.1%
4/36 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
22.2%
8/36 • Number of events 8
|
|
General disorders
rigors
|
13.9%
5/36 • Number of events 5
|
|
General disorders
scratchy throat
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
seasonal allergies
|
25.0%
9/36 • Number of events 9
|
|
General disorders
shaky
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
16.7%
6/36 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
shoulder discomfort/pain
|
19.4%
7/36 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
25.0%
9/36 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
sinus drainage
|
13.9%
5/36 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
sinus pressure
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
sinus thickening
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis
|
19.4%
7/36 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
skin abrasion
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin erythema
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin hyperpigmentation
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin wound
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
shortness of breath with exertion
|
8.3%
3/36 • Number of events 3
|
|
General disorders
somnolence
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
sore throat
|
41.7%
15/36 • Number of events 15
|
|
Infections and infestations
staph bacteremia
|
5.6%
2/36 • Number of events 2
|
|
Endocrine disorders
steroid induced diabetes
|
11.1%
4/36 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
steroid myopathy
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
swelling at CVC
|
5.6%
2/36 • Number of events 2
|
|
General disorders
swelling of the neck
|
5.6%
2/36 • Number of events 2
|
|
General disorders
swelling of upper extremities
|
5.6%
2/36 • Number of events 2
|
|
General disorders
syncope
|
8.3%
3/36 • Number of events 3
|
|
Cardiac disorders
tachycardia
|
47.2%
17/36 • Number of events 17
|
|
Gastrointestinal disorders
taste alterations
|
25.0%
9/36 • Number of events 9
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
86.1%
31/36 • Number of events 31
|
|
Gastrointestinal disorders
tonsillar adenopathy
|
5.6%
2/36 • Number of events 2
|
|
General disorders
tremors
|
27.8%
10/36 • Number of events 10
|
|
General disorders
unsteady gait/balance
|
8.3%
3/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
upper extremity weakness
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
5.6%
2/36 • Number of events 2
|
|
Renal and urinary disorders
urinary frequency
|
27.8%
10/36 • Number of events 10
|
|
Renal and urinary disorders
urinary hesitancy
|
8.3%
3/36 • Number of events 3
|
|
Renal and urinary disorders
urinary incontinence
|
13.9%
5/36 • Number of events 5
|
|
Renal and urinary disorders
urinary retention
|
5.6%
2/36 • Number of events 2
|
|
Renal and urinary disorders
urinary urgency
|
13.9%
5/36 • Number of events 5
|
|
Eye disorders
visual changes
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
vomitting
|
75.0%
27/36 • Number of events 27
|
|
Infections and infestations
VRE
|
8.3%
3/36 • Number of events 3
|
|
Eye disorders
watery eyes
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
WBC
|
86.1%
31/36 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
weakness
|
52.8%
19/36 • Number of events 19
|
|
Metabolism and nutrition disorders
weight loss
|
19.4%
7/36 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
13.9%
5/36 • Number of events 5
|
Additional Information
Scott R. Solomon, MD
Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place