Trial Outcomes & Findings for High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant (NCT NCT03128359)
NCT ID: NCT03128359
Last Updated: 2024-01-09
Results Overview
Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
From stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen B (Fludarabine, Busulfan, PBSC HCT, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
0
|
19
|
|
Overall Study
COMPLETED
|
19
|
0
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen B (Fludarabine, Busulfan, PBSC HCT, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
—
|
44 years
n=5 Participants
|
53 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
—
|
11 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
—
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
—
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
—
|
19 participants
n=5 Participants
|
38 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact.
Outcome measures
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
|---|---|---|
|
Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year
|
53 percentage of survival probability
Interval 29.0 to 72.0
|
84 percentage of survival probability
Interval 59.0 to 95.0
|
SECONDARY outcome
Timeframe: Up to 100 days post-stem cell infusionAcute graft versus host disease is graded according to the 1994 Keystone Consensus Grading. aGVHD grade was evaluated from day 0 through 100 days post-transplant. The first day of acute GVHD onset at grades 2-4 was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events.
Outcome measures
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
|---|---|---|
|
Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading
|
47 percentage of probability
Interval 29.0 to 76.0
|
53 percentage of probability
Interval 34.0 to 81.0
|
SECONDARY outcome
Timeframe: From start of transplant to death, or last follow up, whichever occurs first, assessed for up to 1 year.Estimates was calculated using the Kaplan-Meier method, Greenwood formula was used to calculate SE, and log-log transformation method was used to construct 95% confidence intervals. Each patient's vital status was monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event was censored at his/her date of last contact.
Outcome measures
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
n=19 Participants
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
|---|---|---|
|
Overall Survival (OS) at 1 Year
|
68 percentage of probability
Interval 42.0 to 84.0
|
100 percentage of probability
The 95% confidence intervals were not calculable because no participant reached the event at the final time point for assessment.
|
Adverse Events
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
Serious events: 12 serious events
Other events: 19 other events
Deaths: 9 deaths
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
n=19 participants at risk
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
n=19 participants at risk
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
HEMOLYSIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DIARRHEA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/19 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
General disorders
CHILLS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
General disorders
FEVER
|
0.00%
0/19 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Infections and infestations
CMV VIREMIA
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
ENTEROBACTER BACTEREMIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
NOCARDIA INFECTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
PNEUMONIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
SEPSIS
|
15.8%
3/19 • Number of events 4 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Investigations
CREATININE INCREASED
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DISEASE RELAPSE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RELAPSED DISEASE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
Other adverse events
| Measure |
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
n=19 participants at risk
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
|
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
n=19 participants at risk
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
|
|---|---|---|
|
Gastrointestinal disorders
SMALL INTESTINAL MUCOSITIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
VOMITING
|
94.7%
18/19 • Number of events 22 • Up to 2 years post-transplant.
|
89.5%
17/19 • Number of events 25 • Up to 2 years post-transplant.
|
|
General disorders
CHILLS
|
57.9%
11/19 • Number of events 12 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
General disorders
EDEMA FACE
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
General disorders
EDEMA LIMBS
|
78.9%
15/19 • Number of events 17 • Up to 2 years post-transplant.
|
57.9%
11/19 • Number of events 13 • Up to 2 years post-transplant.
|
|
General disorders
FATIGUE
|
94.7%
18/19 • Number of events 21 • Up to 2 years post-transplant.
|
94.7%
18/19 • Number of events 23 • Up to 2 years post-transplant.
|
|
General disorders
FEVER
|
84.2%
16/19 • Number of events 19 • Up to 2 years post-transplant.
|
73.7%
14/19 • Number of events 14 • Up to 2 years post-transplant.
|
|
General disorders
GAIT DISTURBANCE
|
5.3%
1/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
General disorders
HYPOTHERMIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
General disorders
INFUSION RELATED REACTION
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
General disorders
IRRITABILITY
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
General disorders
LOCALIZED EDEMA
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
General disorders
MALAISE
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
General disorders
NONCARDIAC CHEST PAIN
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
General disorders
PAIN
|
57.9%
11/19 • Number of events 18 • Up to 2 years post-transplant.
|
31.6%
6/19 • Number of events 8 • Up to 2 years post-transplant.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Immune system disorders
ALLERGIC REACTION
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
ADENOVIRUS VIREMA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
BLADDER INFECTION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Infections and infestations
CITROBACTER FREUNDII BACTEREMIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
CMV
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
CMV REACTIVATION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
CMV VIREMIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Infections and infestations
CORONAVIRUS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
E COLI BACTEREMIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
ENTEROCOCCUS FAECALIS INFECTION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
HERPES SIMPLEX
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
HERPES VIRUS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
KLEBSIELLA PNEUMONIAIE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
LUNG INFECTION
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
NAIL INFECTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
POSITIVE CMV PCR
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
S. VIRIDANS BACTEREMIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
SEPSIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Ear and labyrinth disorders
EAR PAIN
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Ear and labyrinth disorders
TINNITUS
|
5.3%
1/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Endocrine disorders
ADRENAL HYPERPLASIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Eye disorders
BLURRED VISION
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Eye disorders
CONJUNCTIVAL HEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Eye disorders
DRY EYE
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Eye disorders
FLASHING LIGHTS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Eye disorders
FLOATERS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Eye disorders
RT EYE IRRITATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Eye disorders
SUBCONJUNCTIVAL HEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
84.2%
16/19 • Number of events 19 • Up to 2 years post-transplant.
|
68.4%
13/19 • Number of events 18 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ANAL HEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ANAL PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ASCITES
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
BLOATING
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
COLITIS
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
CONSTIPATION
|
31.6%
6/19 • Number of events 7 • Up to 2 years post-transplant.
|
31.6%
6/19 • Number of events 10 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DIARRHEA
|
100.0%
19/19 • Number of events 22 • Up to 2 years post-transplant.
|
100.0%
19/19 • Number of events 20 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DRY MOUTH
|
68.4%
13/19 • Number of events 14 • Up to 2 years post-transplant.
|
47.4%
9/19 • Number of events 11 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DUODENAL HEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
FLATULENCE
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
GASTRITIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
GASTROPARESIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
HEMORRHOIDAL HEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
42.1%
8/19 • Number of events 8 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ILEUS
|
5.3%
1/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
68.4%
13/19 • Number of events 15 • Up to 2 years post-transplant.
|
89.5%
17/19 • Number of events 18 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
19/19 • Number of events 33 • Up to 2 years post-transplant.
|
100.0%
19/19 • Number of events 30 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
ORAL PAIN
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
PERIANAL PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
RECTAL PAIN
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Gastrointestinal disorders
SALIVARY DUCT INFLAMMATION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
ANEMIA
|
100.0%
19/19 • Number of events 43 • Up to 2 years post-transplant.
|
100.0%
19/19 • Number of events 38 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
89.5%
17/19 • Number of events 20 • Up to 2 years post-transplant.
|
47.4%
9/19 • Number of events 9 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
HEMOLYSIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
HEMOLYTIC UREMIC SYNDROME
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
LEFT NECK NODULE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
CARDIOMEGALY
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
CHEST PAIN CARDIAC
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
GR DIASTOLIC DYSFUNCTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
HEART FAILURE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Cardiac disorders
PAROXYSMAL ATRIAL TACHYCARDIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
36.8%
7/19 • Number of events 9 • Up to 2 years post-transplant.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
89.5%
17/19 • Number of events 20 • Up to 2 years post-transplant.
|
84.2%
16/19 • Number of events 21 • Up to 2 years post-transplant.
|
|
Cardiac disorders
SR WITH PVCS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
SKIN INFECTION
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
STEM CELL PRODUCT GRAM POSITIVE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Infections and infestations
VIRIDANS STREPTOCOCCI BACTEREMIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Injury, poisoning and procedural complications
BRUISING
|
52.6%
10/19 • Number of events 12 • Up to 2 years post-transplant.
|
42.1%
8/19 • Number of events 8 • Up to 2 years post-transplant.
|
|
Injury, poisoning and procedural complications
FALL
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Injury, poisoning and procedural complications
LIP LESION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Injury, poisoning and procedural complications
SKIN EXCORIATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
42.1%
8/19 • Number of events 9 • Up to 2 years post-transplant.
|
36.8%
7/19 • Number of events 7 • Up to 2 years post-transplant.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
42.1%
8/19 • Number of events 8 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
42.1%
8/19 • Number of events 9 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Investigations
CARDIAC TROPONIN I INCREASED
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Investigations
CREATININE INCREASED
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
100.0%
19/19 • Number of events 34 • Up to 2 years post-transplant.
|
100.0%
19/19 • Number of events 32 • Up to 2 years post-transplant.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
100.0%
19/19 • Number of events 27 • Up to 2 years post-transplant.
|
89.5%
17/19 • Number of events 27 • Up to 2 years post-transplant.
|
|
Investigations
PLATELET COUNT DECREASED
|
94.7%
18/19 • Number of events 29 • Up to 2 years post-transplant.
|
100.0%
19/19 • Number of events 34 • Up to 2 years post-transplant.
|
|
Investigations
WEIGHT GAIN
|
63.2%
12/19 • Number of events 13 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 6 • Up to 2 years post-transplant.
|
|
Investigations
WEIGHT LOSS
|
31.6%
6/19 • Number of events 7 • Up to 2 years post-transplant.
|
57.9%
11/19 • Number of events 13 • Up to 2 years post-transplant.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
94.7%
18/19 • Number of events 33 • Up to 2 years post-transplant.
|
94.7%
18/19 • Number of events 34 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
ALKALOSIS
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
84.2%
16/19 • Number of events 21 • Up to 2 years post-transplant.
|
84.2%
16/19 • Number of events 20 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
21.1%
4/19 • Number of events 5 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
36.8%
7/19 • Number of events 7 • Up to 2 years post-transplant.
|
68.4%
13/19 • Number of events 13 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
94.7%
18/19 • Number of events 23 • Up to 2 years post-transplant.
|
89.5%
17/19 • Number of events 23 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
73.7%
14/19 • Number of events 16 • Up to 2 years post-transplant.
|
52.6%
10/19 • Number of events 11 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
10.5%
2/19 • Number of events 4 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
100.0%
19/19 • Number of events 28 • Up to 2 years post-transplant.
|
94.7%
18/19 • Number of events 26 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
100.0%
19/19 • Number of events 22 • Up to 2 years post-transplant.
|
89.5%
17/19 • Number of events 19 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
100.0%
19/19 • Number of events 29 • Up to 2 years post-transplant.
|
100.0%
19/19 • Number of events 29 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
73.7%
14/19 • Number of events 19 • Up to 2 years post-transplant.
|
63.2%
12/19 • Number of events 12 • Up to 2 years post-transplant.
|
|
Metabolism and nutrition disorders
OBESITY
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
31.6%
6/19 • Number of events 7 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
68.4%
13/19 • Number of events 13 • Up to 2 years post-transplant.
|
47.4%
9/19 • Number of events 12 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
31.6%
6/19 • Number of events 7 • Up to 2 years post-transplant.
|
42.1%
8/19 • Number of events 11 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
DYSTONIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
68.4%
13/19 • Number of events 17 • Up to 2 years post-transplant.
|
52.6%
10/19 • Number of events 13 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
HIP PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
MYOCLONIC JERKS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
57.9%
11/19 • Number of events 14 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 6 • Up to 2 years post-transplant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FOCAL INTRAMUCOSAL ADENOCARCINOMA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Nervous system disorders
AMNESIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Nervous system disorders
CONCENTRATION IMPAIRMENT
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Nervous system disorders
DIZZINESS
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Nervous system disorders
DYSGEUSIA
|
42.1%
8/19 • Number of events 8 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 6 • Up to 2 years post-transplant.
|
|
Nervous system disorders
DYSPHASIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Nervous system disorders
HEADACHE
|
68.4%
13/19 • Number of events 17 • Up to 2 years post-transplant.
|
84.2%
16/19 • Number of events 23 • Up to 2 years post-transplant.
|
|
Nervous system disorders
HYPERSOMNIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Nervous system disorders
LETHARGY
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Nervous system disorders
PARESTHESIA
|
21.1%
4/19 • Number of events 5 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
42.1%
8/19 • Number of events 10 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Nervous system disorders
PRESYNCOPE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Nervous system disorders
SOMNOLENCE
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Nervous system disorders
SYNCOPE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Nervous system disorders
TREMOR
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
AGGRAVATION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
AGITATION
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
ANXIETY
|
52.6%
10/19 • Number of events 14 • Up to 2 years post-transplant.
|
42.1%
8/19 • Number of events 10 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
CONFUSION
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
DELIRIUM
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
DEPRESSION
|
10.5%
2/19 • Number of events 3 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
HALLUCINATIONS
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
INSOMNIA
|
42.1%
8/19 • Number of events 8 • Up to 2 years post-transplant.
|
52.6%
10/19 • Number of events 10 • Up to 2 years post-transplant.
|
|
Psychiatric disorders
RESTLESSNESS
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
ACUTE RENAL INSUFFICIENCY
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
BLADDER SPASM
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
BPH
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
DYSURIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
HEMATURIA
|
57.9%
11/19 • Number of events 11 • Up to 2 years post-transplant.
|
36.8%
7/19 • Number of events 7 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
PROTEINURIA
|
47.4%
9/19 • Number of events 9 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
21.1%
4/19 • Number of events 5 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Renal and urinary disorders
URINARY URGENCY
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
PENILE PAIN
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
SCROTAL EDEMA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
VAGINAL HEMORRHAGE
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
VAGINAL ITCH
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
VAGINAL PAIN
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Reproductive system and breast disorders
VAGINAL SORES
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
36.8%
7/19 • Number of events 8 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
36.8%
7/19 • Number of events 9 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
31.6%
6/19 • Number of events 8 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CRACKLES
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
26.3%
5/19 • Number of events 6 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
PULOMONARY NODULES
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
SENSITIVITY TO SMELL
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
31.6%
6/19 • Number of events 7 • Up to 2 years post-transplant.
|
47.4%
9/19 • Number of events 10 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
ALLERGIC DERMITIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
52.6%
10/19 • Number of events 12 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA TOE
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
FOLLICULAR SKIN LESIONS
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
HICKMAN CATHETER EXIT SITE REDNESS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
HICKMAN SITE INFLAMMATION
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
L ANKLE LACERATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
L THIGH TUMOR
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
LEFT TOE INFLAMMATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
PALLOR
|
0.00%
0/19 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
PALMARPLANTAR ERYTHRODYSESTHESIA SYNDROME
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL EDEMA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
10.5%
2/19 • Number of events 2 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
36.8%
7/19 • Number of events 8 • Up to 2 years post-transplant.
|
52.6%
10/19 • Number of events 11 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
0.00%
0/19 • Up to 2 years post-transplant.
|
15.8%
3/19 • Number of events 3 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
RASH MACULOPAPULAR
|
52.6%
10/19 • Number of events 10 • Up to 2 years post-transplant.
|
57.9%
11/19 • Number of events 12 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
RED SPOTS ON CALVES
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
SCALP PAIN
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
SKIN ABRASION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
21.1%
4/19 • Number of events 4 • Up to 2 years post-transplant.
|
31.6%
6/19 • Number of events 6 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Vascular disorders
FLUSHING
|
36.8%
7/19 • Number of events 7 • Up to 2 years post-transplant.
|
26.3%
5/19 • Number of events 5 • Up to 2 years post-transplant.
|
|
Vascular disorders
HEMATOMA
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Vascular disorders
HYPERTENSION
|
89.5%
17/19 • Number of events 32 • Up to 2 years post-transplant.
|
89.5%
17/19 • Number of events 23 • Up to 2 years post-transplant.
|
|
Vascular disorders
HYPOTENSION
|
57.9%
11/19 • Number of events 13 • Up to 2 years post-transplant.
|
47.4%
9/19 • Number of events 13 • Up to 2 years post-transplant.
|
|
Vascular disorders
SUPERFICIAL THROMBOPHLEBITIS
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
|
Vascular disorders
VASCULAR CONGESTION
|
5.3%
1/19 • Number of events 1 • Up to 2 years post-transplant.
|
0.00%
0/19 • Up to 2 years post-transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place