Trial Outcomes & Findings for Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer (NCT NCT00782379)
NCT ID: NCT00782379
Last Updated: 2013-11-21
Results Overview
Number of patients who experienced graft rejection by Day 100
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 100
Results posted on
2013-11-21
Participant Flow
Patients were consented between 12/17/08 through 01/13/11. The transplants occured between 1/13/09 and 3/2/11
NA - this study did not use group assignments. All patients received the same preparative regimen consisting of Fludarabine 25 mg/m2 x 5 days, busulfan 110 mg/m2 x4 days, cyclophosphamide 14.5 mg x 2 days PRE transplant and cyclophosphamide 50 mg x2 days POST transplant
Participant milestones
| Measure |
Haploidentical Transplant
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Haploidentical Transplant
n=20 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
41.75 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 100Population: 20 patients were treated and able to be analyzed for graft rejection
Number of patients who experienced graft rejection by Day 100
Outcome measures
| Measure |
Haploidentical Transplant
n=20 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Incidence of Graft Rejection for Patients at Day 100
|
0 participants
|
PRIMARY outcome
Timeframe: Day 100Population: 17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence
Outcome measures
| Measure |
Haploidentical Transplant
n=17 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
|
2 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.
Outcome measures
| Measure |
Haploidentical Transplant
n=20 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Overall Survival at Day 100
|
17 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality.
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
Outcome measures
| Measure |
Haploidentical Transplant
n=6 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
|
2 participants
|
SECONDARY outcome
Timeframe: Day 30Population: 18 patients had Day 30 chimerism drawn
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Outcome measures
| Measure |
Haploidentical Transplant
n=18 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
|
18 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality
Outcome measures
| Measure |
Haploidentical Transplant
n=2 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
|
2 participants
|
SECONDARY outcome
Timeframe: Day 60Population: 18 patients had chimerism drawn at Day 60
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Outcome measures
| Measure |
Haploidentical Transplant
n=18 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
|
18 participants
|
SECONDARY outcome
Timeframe: Day 90Population: 13 patients had chimerism drawn at Day 90
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Outcome measures
| Measure |
Haploidentical Transplant
n=13 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
|
13 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year
Overall survival, defined as a patient being alive after transplant, is without regard to disease status.
Outcome measures
| Measure |
Haploidentical Transplant
n=20 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Overall Survival at 12 Months
|
14 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.
Outcome measures
| Measure |
Haploidentical Transplant
n=14 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Disease Free Survival at 12 Months
|
7 participants
|
SECONDARY outcome
Timeframe: Day 100Population: 17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.
Outcome measures
| Measure |
Haploidentical Transplant
n=17 Participants
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Disease Free Survival at Day 100
|
16 participants
|
Adverse Events
Haploidentical Transplant
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Haploidentical Transplant
n=20 participants at risk
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
Immune system disorders
Acute graft versus host disease
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
BK virus
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
Chest pain
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
Colitis
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Nervous system disorders
Confusion
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
Death
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Nervous system disorders
Hypoglycemia induced hemiparesis
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
Infection with normal ANC
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
pericardial effusion
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
pneumonia
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
5.0%
1/20 • Number of events 1
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
Other adverse events
| Measure |
Haploidentical Transplant
n=20 participants at risk
Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
|
|---|---|
|
General disorders
Constitutional - feeling cold
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
abdominal cramping
|
50.0%
10/20 • Number of events 10
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
abdominal distension
|
30.0%
6/20 • Number of events 6
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
abdominal pain
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
abdominal tenderness
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
abnormal taste
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Nervous system disorders
agitation
|
30.0%
6/20 • Number of events 6
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Metabolism and nutrition disorders
ALK PHOS
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Hepatobiliary disorders
ALT
|
85.0%
17/20 • Number of events 17
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
Altered taste
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar hemorrhage
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
ANC
|
85.0%
17/20 • Number of events 17
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
18/20 • Number of events 18
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Metabolism and nutrition disorders
Anorexia/decreased appetite
|
85.0%
17/20 • Number of events 17
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Psychiatric disorders
Anxiety
|
80.0%
16/20 • Number of events 16
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Hepatobiliary disorders
AST
|
60.0%
12/20 • Number of events 12
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
35.0%
7/20 • Number of events 7
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
BK virus
|
75.0%
15/20 • Number of events 15
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
Bladder pain
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
Bladder pressure
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
bladder spasms
|
35.0%
7/20 • Number of events 7
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
bloating
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
bradycardia
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
bruising
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
c-diff
|
35.0%
7/20 • Number of events 7
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
cardiomyopathy
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
chills
|
75.0%
15/20 • Number of events 15
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
CMV
|
55.0%
11/20 • Number of events 11
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
Coag Neg Staph
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Psychiatric disorders
confusion
|
30.0%
6/20 • Number of events 6
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
constipation
|
40.0%
8/20 • Number of events 8
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
85.0%
17/20 • Number of events 17
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
creatinine
|
70.0%
14/20 • Number of events 14
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
cvc bleeding
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
cvc erythema
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
cvc tenderness/pain
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
decreased EF
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Psychiatric disorders
depression
|
65.0%
13/20 • Number of events 13
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
diaphoresis
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
diarrhea
|
95.0%
19/20 • Number of events 19
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
difficulty swallowing
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
dizziness
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
drowsiness
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Eye disorders
dry eyes
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
dry lips
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
dry mouth
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
edema
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
epistaxis
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
erythema
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
esophagitis
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
facial edema
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
fatigue
|
95.0%
19/20 • Number of events 19
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
fever
|
90.0%
18/20 • Number of events 18
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Psychiatric disorders
flat affect
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
flatulence
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
fluid overload
|
30.0%
6/20 • Number of events 6
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
general deconditioning
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
GERD/dyspepsia
|
70.0%
14/20 • Number of events 14
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
GI distress
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
gram + bacteremia
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Psychiatric disorders
hallucinations
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
headache
|
35.0%
7/20 • Number of events 7
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Ear and labyrinth disorders
hearing loss
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
hematuria
|
50.0%
10/20 • Number of events 10
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
hemorrhagic cystitis
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
hemorrhoids
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
hiccoughs
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Immune system disorders
hives
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
40.0%
8/20 • Number of events 8
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypercalcemia
|
55.0%
11/20 • Number of events 20
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hyperglycemia
|
95.0%
19/20 • Number of events 20
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
hyperkalemia
|
60.0%
12/20 • Number of events 12
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
hypermagnesemia
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
hypernatremia
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hyperphosphatemia
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
hyperpigmented skin
|
35.0%
7/20 • Number of events 7
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
hypertension
|
55.0%
11/20 • Number of events 11
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypoalbuminemia
|
75.0%
15/20 • Number of events 15
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypocalcemia
|
70.0%
14/20 • Number of events 14
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypoglycemia
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypokalemia
|
75.0%
15/20 • Number of events 15
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypomagnesemia
|
90.0%
18/20 • Number of events 18
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hyponatremia
|
60.0%
12/20 • Number of events 12
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Investigations
hypophosphatemia
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
hypopigmentation
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
hypotension
|
40.0%
8/20 • Number of events 8
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
increased oral secretions
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
increased PT
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
insomnia
|
70.0%
14/20 • Number of events 14
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
lethargy
|
30.0%
6/20 • Number of events 6
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
lip lesion
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
LE edema
|
50.0%
10/20 • Number of events 10
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
MRSE
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
mucositis
|
100.0%
20/20 • Number of events 20
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
40.0%
8/20 • Number of events 8
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
nausea
|
95.0%
19/20 • Number of events 19
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Musculoskeletal and connective tissue disorders
neck stiffness
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
neutropenic fever
|
30.0%
6/20 • Number of events 6
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
night sweats
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
pain
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
parainfluenza
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Reproductive system and breast disorders
penile pain
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Eye disorders
periorbital edema
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Nervous system disorders
peripheral neuropathy
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
90.0%
18/20 • Number of events 18
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infiltrates
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
rash
|
75.0%
15/20 • Number of events 15
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
reactive airway disease
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
rectal discomfort
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
renal insufficiency
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
restlessness
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
rigors
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
RSV
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Immune system disorders
seasonal allergies
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Musculoskeletal and connective tissue disorders
shoulder discomfort
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
sinus drainage
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
skin discoloration
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Skin and subcutaneous tissue disorders
skin tear
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
sore throat
|
35.0%
7/20 • Number of events 7
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
staph epi
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
stool incontinence
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
suprapubic pain
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Cardiac disorders
tachycardia
|
95.0%
19/20 • Number of events 19
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
tachypnea
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
throat pain
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
85.0%
17/20 • Number of events 17
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
thrush
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Nervous system disorders
tremors
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
unsteady gait
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
urinary burning
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
urinary frequency
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
urinary incontinence
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Renal and urinary disorders
urinary urgency
|
25.0%
5/20 • Number of events 5
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Reproductive system and breast disorders
vaginal spotting/bleeding
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Eye disorders
visual changes
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Gastrointestinal disorders
vomitting
|
95.0%
19/20 • Number of events 19
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Infections and infestations
VRE
|
20.0%
4/20 • Number of events 4
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Blood and lymphatic system disorders
Decreased WBC
|
90.0%
18/20 • Number of events 18
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
weakness
|
45.0%
9/20 • Number of events 9
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
weight gain
|
10.0%
2/20 • Number of events 2
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
General disorders
weight loss
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
15.0%
3/20 • Number of events 3
Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals.
|
Additional Information
Dr. Scott Solomon
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
Restriction type: LTE60