Trial Outcomes & Findings for Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention (NCT NCT01951885)
NCT ID: NCT01951885
Last Updated: 2023-09-11
Results Overview
Participants (percentage of) will be graded three times per week through day 28 of the study. Incidence will be compared through Wilcoxon rank sum tests. The WHO grading scale for mucositis is scaled depending on the severity of mucositis symptoms, with a lower stage associated with a better outcome and greater stages associated with worse outcomes. The staging is as follows: Stage 0: None Stage 1 (mild): Oral soreness, erythema Stage 2 (moderate): Oral erythema, ulcers, solid diet tolerated Stage 3 (severe): Oral ulcers, liquid diet only Stage 4 (life-threatening): Oral alimentation impossible
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Up to day 28
Results posted on
2023-09-11
Participant Flow
Participants were recruited from local hospital from July 2014 thru July 2020
Participant milestones
| Measure |
Group A (Tacrolimus, Methotrexate)
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Group A (Tacrolimus, Methotrexate)
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Overall Study
ineligible due to a change in conditioning regimen
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
ineligible due to a change in donor
|
0
|
1
|
|
Overall Study
ineligible after experiencing cardiac issues
|
0
|
1
|
Baseline Characteristics
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
Baseline characteristics by cohort
| Measure |
Group A (Tacrolimus, Methotrexate)
n=50 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=51 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
0-9 years old
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Customized
10-19 years old
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Customized
20-29 years old
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Customized
30-39 years old
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Customized
40-49 years old
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Customized
50-59 years old
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Customized
60-69 years old
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
51 participants
n=107 Participants
|
101 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to day 28Population: participants that completed study
Participants (percentage of) will be graded three times per week through day 28 of the study. Incidence will be compared through Wilcoxon rank sum tests. The WHO grading scale for mucositis is scaled depending on the severity of mucositis symptoms, with a lower stage associated with a better outcome and greater stages associated with worse outcomes. The staging is as follows: Stage 0: None Stage 1 (mild): Oral soreness, erythema Stage 2 (moderate): Oral erythema, ulcers, solid diet tolerated Stage 3 (severe): Oral ulcers, liquid diet only Stage 4 (life-threatening): Oral alimentation impossible
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Percentage of Severe (Grade 3-4) Mucositis Graded According to the World Health Organization (WHO) Grading Scale
|
81.6 percentage of participants
|
57.4 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: participants that were able to engraft neutrophils
The number of days to reach a neutrophil count of greater than or equal to 500/ul for three consecutive laboratory values obtained on different days. The day of engraftment will be the first day of the three consecutive laboratory values.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=47 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Time to Neutrophil Engraftment
|
17 days
Interval 11.0 to 27.0
|
15 days
Interval 11.0 to 23.0
|
PRIMARY outcome
Timeframe: The date the participant engrafts, up to 28 daysPopulation: participants that were able to engraft platelets
The number of days to reach a platelet count of greater than or equal to 20,000/ul for three consecutive laboratory values obtained on different days, independent of platelet transfusions the prior 7 days. The day of engraftment will be the first day of the three consecutive laboratory values. For cases of delayed engraftment beyond 28 days, results will be recorded once the participant engrafts.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=27 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=23 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Time to Platelet Engraftment
|
27 days
Interval 16.0 to 131.0
|
23 days
Interval 10.0 to 112.0
|
PRIMARY outcome
Timeframe: Day 7- Day 100Population: participants who completed the study
Acute GVHD by grade will be estimated using cumulative incidence methods and compared using the Gray test. A lower clinical grade and/or stage of GVHD corresponds to a better participant outcome and a higher grade corresponds to a worse participant outcome. Grading is as follows: Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade 2: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade 3: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade 4: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI. A greater stage of GVHD involves worsening end-organ involvement and worse participant outcomes based on the skin, liver, lower GI, and upper GI.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Cumulative Incidence of Participants With Acute GVHD
Grade 1-4
|
37 percentage of participants
Interval 23.0 to 50.0
|
47 percentage of participants
Interval 32.0 to 60.0
|
|
Cumulative Incidence of Participants With Acute GVHD
Grade 2-4
|
27 percentage of participants
Interval 15.0 to 39.0
|
28 percentage of participants
Interval 16.0 to 41.0
|
|
Cumulative Incidence of Participants With Acute GVHD
Grade 3-4
|
4 percentage of participants
Interval 1.0 to 12.0
|
13 percentage of participants
Interval 5.0 to 24.0
|
SECONDARY outcome
Timeframe: Date of transplant to date of discharge, assessed up to 1 yearPopulation: participants who completed the study
Hospital stay will be compared between patients in groups A and B using the Wilcoxon rank sum test.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Length of Hospitalization
|
31 days
Interval 22.0 to 89.0
|
27 days
Interval 20.0 to 55.0
|
SECONDARY outcome
Timeframe: Up to day 100Population: participants who completed the study
TPN use will be compared using the Chi-square test.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Percentage of Participants Using Total Parenteral Nutrition (TPN) Within 100 Days
|
41 percentage of participants
|
38 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: participants who completed the study
Estimated using the Kaplan-Meier method and compared between the 2 groups using the log-rank test.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Overall Survival
|
71 percentage of participants
Interval 56.0 to 82.0
|
72 percentage of participants
Interval 57.0 to 83.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: participants who completed the study
Estimated using the Kaplan-Meier method and compared between the 2 groups using the log-rank test.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Progression-free Survival
|
59 percentage of participants
Interval 44.0 to 71.0
|
68 percentage of participants
Interval 53.0 to 79.0
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: participants who completed the study
Chronic GVHD will be graded as mild, moderate, or severe based on the National Institutes of Health Consensus Development Project. The type and duration of immunosuppressive treatment given for cGVHD will be recorded. Mild grades are associated with a better participant outcome and severe corresponds to a worse participant outcome. Grading is as follows: Mild: 1 or 2 organs involved with no more than score 1 plus Lung score 0 Moderate: 3 or more organs involved with no more than score 1 OR At least 1 organ (not lung) with a score of 2 OR Lung score 1 Severe: At least 1 organ with a score of 3 OR Lung score of 2 or 3 Organ scores can range from 0 to 3, with 0 being no symptoms on the target organ and a better participant outcome while a score of 3 correlates to severe symptoms on the target organ and worse participant outcomes. Potential target organs include: skin, mouth, eyes, GI tract, liver, lungs, joint /fascia, and genital tract
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Chronic GVHD
any chronic GVHD
|
16 percentage of participants
Interval 8.0 to 28.0
|
15 percentage of participants
Interval 6.0 to 27.0
|
|
Incidence of Chronic GVHD
moderate-severe chronic GVHD
|
12 percentage of participants
Interval 5.0 to 23.0
|
11 percentage of participants
Interval 4.0 to 21.0
|
SECONDARY outcome
Timeframe: at 12 monthsPopulation: participants who completed the study
Chronic GVHD will be graded as mild, moderate, or severe based on the National Institutes of Health Consensus Development Project. The type and duration of immunosuppressive treatment given for cGVHD will be recorded. Mild grades are associated with a better participant outcome and severe corresponds to a worse participant outcome. Grading is as follows: Mild: 1 or 2 organs involved with no more than score 1 plus Lung score 0 Moderate: 3 or more organs involved with no more than score 1 OR At least 1 organ (not lung) with a score of 2 OR Lung score 1 Severe: At least 1 organ with a score of 3 OR Lung score of 2 or 3 Organ scores can range from 0 to 3, with 0 being no symptoms on the target organ and a better participant outcome while a score of 3 correlates to severe symptoms on the target organ and worse participant outcomes. Potential target organs include: skin, mouth, eyes, GI tract, liver, lungs, joint /fascia, and genital tract
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Chronic GVHD
moderate-severe chronic GVHD
|
20 percentage of participants
Interval 10.0 to 33.0
|
23 percentage of participants
Interval 12.0 to 36.0
|
|
Incidence of Chronic GVHD
any chronic GVHD
|
25 percentage of participants
Interval 13.0 to 37.0
|
36 percentage of participants
Interval 23.0 to 50.0
|
SECONDARY outcome
Timeframe: up to +28 dayPopulation: Participants that were on continuous infusion narcotics
Start and stop dates for the need of continuous IV infusion of narcotics for severe mucositis pain will be recorded. Time on IV infusion will be compared between patients in groups A and B using the Wilcoxon rank sum test.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Length of Time on Continuous Infusion Narcotics
|
10 days
Interval 1.0 to 19.0
|
9 days
Interval 2.0 to 25.0
|
SECONDARY outcome
Timeframe: Up to day +100Population: participants that completed the study
100-day incidence of infection will be compared using a the Gray test.
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Infection
|
63 percentage of participants
Interval 48.0 to 75.0
|
53 percentage of participants
Interval 38.0 to 66.0
|
SECONDARY outcome
Timeframe: Up to day +100Population: participants that completed the study
100-day incidence of hepatotoxicity will be compared using a Gray test. Median and range of largest total bilirubin (mg/dL),
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Hepatotoxicity as Measured by Bilirubin
|
1.5 mg/dL
Interval 0.4 to 45.2
|
1.1 mg/dL
Interval 0.4 to 43.8
|
SECONDARY outcome
Timeframe: Up to day +100Population: participants that completed the study
100-day incidence of hepatotoxicity will be compared using a Gray test. Percentage of patients with elevated Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and alkaline phosphatase and a 95% confidence interval
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes
AST
|
29 percentage of participants
Interval 17.0 to 43.0
|
15 percentage of participants
Interval 6.0 to 28.0
|
|
Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes
ALT
|
33 percentage of participants
Interval 20.0 to 48.0
|
28 percentage of participants
Interval 16.0 to 43.0
|
|
Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes
Alkaline Phosphatase
|
2 percentage of participants
Interval 0.0 to 11.0
|
2 percentage of participants
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to day +100Population: participants that completed the study
100-day incidence of hepatotoxicity will be compared using the Gray test. Percentage of patients with VOD and 95% confidence interval
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Hepatotoxicity as Measured by Veno-occlusive Disease (VOD)
|
8 percentage of participants
Interval 2.0 to 20.0
|
2 percentage of participants
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to day +100Population: participants that completed the study
100-day incidence of nephrotoxicity will be compared using a Chi-squared test. Percentage of patients requiring dialysis and those with elevated creatinine using a 95% confidence interval
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Nephrotoxicity
Participants requiring dialysis
|
12 percentage of participants
Interval 5.0 to 25.0
|
4 percentage of participants
Interval 1.0 to 15.0
|
|
Incidence of Nephrotoxicity
Participants with elevated creatinine
|
27 percentage of participants
Interval 15.0 to 41.0
|
2 percentage of participants
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to day +180Population: participants that completed the study
180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with pulmonary hemorrhage and 95% confidence interval
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Pulmonary Toxicity Measured by Pulmonary Hemorrhage
|
2 percentage of participants
Interval 0.0 to 11.0
|
2 percentage of participants
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to day +180Population: participants that completed the study
180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with pulmonary edema and 95% confidence interval
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Pulmonary Toxicity Measured by Pulmonary Edema
|
14 percentage of participants
Interval 6.0 to 27.0
|
4 percentage of participants
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to day +180Population: participants that completed the study
180-day incidence of pulmonary toxicity will be compared using the Gray test. Percentage of patients with respiratory failure and 95% confidence interval
Outcome measures
| Measure |
Group A (Tacrolimus, Methotrexate)
n=49 Participants
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=47 Participants
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Incidence of Pulmonary Toxicity Measured by Respiratory Failure
|
9 percentage of participants
Interval 4.0 to 15.0
|
6 percentage of participants
Interval 1.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to one yearDonor chimerism will be assessed by analysis of single-tandem repeats on whole marrow and in lymphocyte enriched or sorted CD3+ T cells and CD33+ granulocytes. Blood will be obtained for donor chimerism "Bone Marrow Engraftment analysis" at approximately 1, 2, 3, 6, 9 and 12 months or as clinically indicated.
Outcome measures
Outcome data not reported
Adverse Events
Group A (Tacrolimus, Methotrexate)
Serious events: 13 serious events
Other events: 49 other events
Deaths: 25 deaths
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
Serious events: 3 serious events
Other events: 47 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Group A (Tacrolimus, Methotrexate)
n=50 participants at risk
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=51 participants at risk
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • Number of events 2 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.0%
1/50 • Number of events 2 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Hepatobiliary disorders
Encephalopathy
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Hepatobiliary disorders
Hepatic failure
|
6.0%
3/50 • Number of events 4 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Escherichia Coli (E-Coli)
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
Seizure
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Number of events 2 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
Other adverse events
| Measure |
Group A (Tacrolimus, Methotrexate)
n=50 participants at risk
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
|
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
n=51 participants at risk
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
adult respiratory distress syndrome
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
agitation
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
abdominal pain
|
52.0%
26/50 • Adverse event data were collected through one year post transplant
|
47.1%
24/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
diarrhea
|
82.0%
41/50 • Adverse event data were collected through one year post transplant
|
84.3%
43/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
32.0%
16/50 • Adverse event data were collected through one year post transplant
|
29.4%
15/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
encephalopathy
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
28.0%
14/50 • Adverse event data were collected through one year post transplant
|
21.6%
11/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
fever
|
66.0%
33/50 • Adverse event data were collected through one year post transplant
|
47.1%
24/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
hyperglycemia
|
18.0%
9/50 • Adverse event data were collected through one year post transplant
|
17.6%
9/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
hypertension
|
44.0%
22/50 • Adverse event data were collected through one year post transplant
|
25.5%
13/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
hypokalemia
|
24.0%
12/50 • Adverse event data were collected through one year post transplant
|
27.5%
14/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
52.0%
26/50 • Adverse event data were collected through one year post transplant
|
64.7%
33/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
20.0%
10/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
nausea
|
96.0%
48/50 • Adverse event data were collected through one year post transplant
|
86.3%
44/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
peripheral motor neuropathy
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
peripheral sensory neuropathy
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
9.8%
5/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
sepsis
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
tremor
|
14.0%
7/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
vomiting
|
86.0%
43/50 • Adverse event data were collected through one year post transplant
|
76.5%
39/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: BK virus
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Candida krusei
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Clostridioides difficile
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Cellulitis
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Citrobacter freundii
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Cytomegalovirus
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Coronavirus HKU1
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: COVID-19
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Escherichia coli
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Enterobacter cloacae complex
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Enterococcus faecalis
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Herpes stomatitis
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Herpes zoster
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Influenza A
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Influenza B
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Klebsiella oxytoca
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Klebsiella pneumoniae
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Methicillin-resistant Staphylococcus aureus
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Methicillin-resistant Staphylococcus epidermidis
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Pulmonary aspergillosis
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Pulmonary mucormycosis
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Raoultella species
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Rhinovirus
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Respiratory syncytial virus
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Sphingomonas (pseudomonas) paucimobilis
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Staphylococcus aureus pneumonia
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Staphylococcus epidermidis
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Streptococcus mitis
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Streptococcus mitis oralis
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Thrush
|
18.0%
9/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
urinary tract infection
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Varicella zoster
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: Vancomycin-resistant enterococci
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
catheter related infection
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
abdominal distension
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
acute kidney injury
|
48.0%
24/50 • Adverse event data were collected through one year post transplant
|
19.6%
10/51 • Adverse event data were collected through one year post transplant
|
|
Immune system disorders
allergic reaction
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
anal fistula
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
anal pain
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
anal ulcer
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Blood and lymphatic system disorders
anemia
|
44.0%
22/50 • Adverse event data were collected through one year post transplant
|
45.1%
23/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
anorexia
|
32.0%
16/50 • Adverse event data were collected through one year post transplant
|
29.4%
15/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
anxiety
|
32.0%
16/50 • Adverse event data were collected through one year post transplant
|
21.6%
11/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
atrial fibrillation
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
avascular necrosis
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
back pain
|
14.0%
7/50 • Adverse event data were collected through one year post transplant
|
23.5%
12/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
bladder infection
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
blurred vision
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
cardiac arrest
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
chills
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
17.6%
9/51 • Adverse event data were collected through one year post transplant
|
|
Hepatobiliary disorders
cholecystitis
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
cholesterol high
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
colitis
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
confusion
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
conjunctivitis
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
constipation
|
50.0%
25/50 • Adverse event data were collected through one year post transplant
|
45.1%
23/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
40.0%
20/50 • Adverse event data were collected through one year post transplant
|
47.1%
24/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
CPK increased
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
dehydration
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
delirium
|
20.0%
10/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
depressed level of consciousness
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
depression
|
14.0%
7/50 • Adverse event data were collected through one year post transplant
|
9.8%
5/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
dizziness
|
14.0%
7/50 • Adverse event data were collected through one year post transplant
|
27.5%
14/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
dry eye
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
dry mouth
|
20.0%
10/50 • Adverse event data were collected through one year post transplant
|
19.6%
10/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
dry skin
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
dysesthesia
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
dysgeusia
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
dyspareunia
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
dyspepsia
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
dysphagia
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Ear and labyrinth disorders
ear pain
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
edema cerebral
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
edema face
|
18.0%
9/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
edema limbs
|
42.0%
21/50 • Adverse event data were collected through one year post transplant
|
39.2%
20/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
electrocardiogram QT corrected interval prolonged
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
enterocolitis
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
18.0%
9/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
erectile dysfunction
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Injury, poisoning and procedural complications
FALL
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
FATIGUE
|
80.0%
40/50 • Adverse event data were collected through one year post transplant
|
68.6%
35/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
FLATULENCE
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
FLOATERS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
FLUSHING
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
FORCED EXPIRATORY VOLUME DECREASED
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Injury, poisoning and procedural complications
FRACTURE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
GAIT DISTURBANCE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
GASTRITIS
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
GASTROPARESIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
18.0%
9/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
GYNECOMASTIA
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
HALLUCINATIONS
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
HEADACHE
|
56.0%
28/50 • Adverse event data were collected through one year post transplant
|
58.8%
30/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
HEMATOMA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
HEMATURIA
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Blood and lymphatic system disorders
HEMOLYSIS
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
HEMORRHOIDAL HEMORRHAGE
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
24.0%
12/50 • Adverse event data were collected through one year post transplant
|
17.6%
9/51 • Adverse event data were collected through one year post transplant
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
HOT FLASHES
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
HYDROCEPHALUS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
20.0%
10/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
HYPOTENSION
|
36.0%
18/50 • Adverse event data were collected through one year post transplant
|
25.5%
13/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
HYPOTHERMIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
INFUSION RELATED REACTION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
INR INCREASED
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
INSOMNIA
|
22.0%
11/50 • Adverse event data were collected through one year post transplant
|
39.2%
20/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
IRRITABILITY
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
joint effusion
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: LABIAL PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: LABIAL ULCER
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL EDEMA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
LARYNGITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
Nervous system disorders - Other, specify: INTRACEREBRAL HEMORRHAGE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
LETHARGY
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
LIBIDO DECREASED
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Endocrine disorders
Endocrine disorders - Other, specify: testosterone deficiency
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: MACROCYTIC ANEMIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
MALAISE
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
MANIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
ALKALOSIS
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
MITRAL VALVE DISEASE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify: MOOD CHANGES
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: MUSCLE CRAMP
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LEFT-SIDED
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: MYOCLONUS
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
22.0%
11/50 • Adverse event data were collected through one year post transplant
|
25.5%
13/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: NASAL DRYNESS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
NECK EDEMA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
26.0%
13/50 • Adverse event data were collected through one year post transplant
|
33.3%
17/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: NIGHT SWEATS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: NOCTURIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: NONOLIGURIC RENAL FAILURE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: ODYNOPHAGIA
|
18.0%
9/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
ORAL DYSESTHESIA
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: OSTEONECROSIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
OTITIS MEDIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.0%
5/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: PAPULAR RASH
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: PAPULE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
PARESTHESIA
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
15.7%
8/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL EDEMA
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: PERIRECTAL FISSURE
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
PHLEBITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
PHOTOPHOBIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
PLATELET COUNT DECREASED
|
40.0%
20/50 • Adverse event data were collected through one year post transplant
|
47.1%
24/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: PNEUMOMEDIASTINUM
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: PNEUMONIA
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
PROCTITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
21.6%
11/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
PSYCHOSIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
RASH
|
34.0%
17/50 • Adverse event data were collected through one year post transplant
|
49.0%
25/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
RECTAL PAIN
|
20.0%
10/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
Eye disorders - Other, specify: RETINAL HEMORRHAGE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: RHINORRHEA
|
12.0%
6/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
General disorders - Other, specify: RIGORS
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
SCALP PAIN
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
SINUS PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: SMALL BOWEL ISCHEMIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: STEROID MYOPATHY
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
STOMACH PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
STROKE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
Eye disorders - Other, specify: SUBCONJUNCTIVAL HEMORRHAGE
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
SUICIDAL IDEATIONS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
SYNCOPE
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
Blood antidiuretic hormone abnormal
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
TACHYCARDIA
|
28.0%
14/50 • Adverse event data were collected through one year post transplant
|
21.6%
11/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: TACHYPNEA
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
TINNITUS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
TUMOR LYSIS SYNDROME
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
TYPHLITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
20.0%
10/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: URINARY HESITANCY
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
URINARY RETENTION
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
URINARY URGENCY
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
9.8%
5/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
VAGINAL HEMORRHAGE
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
VAGINAL INFLAMMATION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: VAGINAL ITCHING
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
VAGINAL PAIN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
Thromboembolic event
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
Investigations - Other, specify: VITAMIN D DEFICIENCY
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
13.7%
7/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
WATERING EYES
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
WEIGHT GAIN
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
WEIGHT LOSS
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
32.0%
16/50 • Adverse event data were collected through one year post transplant
|
33.3%
17/51 • Adverse event data were collected through one year post transplant
|
|
Reproductive system and breast disorders
irregular menstruation
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
Eye disorders - Other, specify: decreased visual acuity
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: dysuria
|
16.0%
8/50 • Adverse event data were collected through one year post transplant
|
21.6%
11/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: folliculitis
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
General disorders, Other, specify: generalized edema
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: glucosuria
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: hyperlipidemia
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: hyperphosphatemia
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
SKIN INFECTION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: ABSCESS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: ACUTE TUBULAR NECROSIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify: ALTERED MENTAL STATUS
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
Eye disorders - Other, specify: ANISOCORIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
BRADYCARDIA
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
Cardiac disorders - Other, specify: CARDIAC MURMUR
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: CERVICAL DISC HERNIATION
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify: CHOLELITHIASIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify: CHOLESTASIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: COLONIC ILEUS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
Eye disorders - Other, specify: CONJUNCTIVAL HEMORRHAGE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: COSTOCHONDRITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: CYSTS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: DERMATITIS
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: ATOPIC DERMATITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: DIAPER DERMATITIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: SEBORRHEIC DERMATITIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: SPONGIOTIC DERMATITIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: DIFFUSE ALVEOLAR HEMORRHAGE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: DIVERTICULITIS
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: DYSTONIA
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: EAR BLEEDING
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: EARLY SATIETY
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: EMPHYSEMA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Infections and infestations
Infections and infestations - Other, specify: GASTROENTERITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: HEMATOCHEZIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
11.8%
6/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
Vascular disorders - Other, specify: SUBDURAL HEMATOMA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: HEMOPTYSIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: HYDRONEPHROSIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
Nervous system disorders - Other, specify: HYPERESTHESIA
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: INCREASE IN APPETITE
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: INDIGESTION
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: RESPIRATORY DISTRESS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: SINUS DRAINAGE
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: HIP PAIN
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: JAW PAIN
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: SHOULDER PAIN
|
8.0%
4/50 • Adverse event data were collected through one year post transplant
|
7.8%
4/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, specify: RIB PAIN
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: HEMORRHAGIC CYSTITIS
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Endocrine disorders
Endocrine disorders - Other, specify: HYPERGONADISM
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: IMPACTED CERUMEN
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
2.0%
1/51 • Adverse event data were collected through one year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: RHONCHI
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: INFARCTION OF SPLEEN
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
General disorders - Other, specify: generalized body aches
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
General disorders - Other, specify: generalized pain
|
0.00%
0/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
24.0%
12/50 • Adverse event data were collected through one year post transplant
|
21.6%
11/51 • Adverse event data were collected through one year post transplant
|
|
Vascular disorders
Vascular disorders - Other, specify: SUBARACHNOID HEMORRHAGE
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Eye disorders
Eye disorders - Other, specify: SUPERFICIAL PUNCTATE KERATITIS
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Nervous system disorders
Nervous system disorders - Other, specify: FOOT DROP
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
Cardiac disorders
Cardiac disorders - Other, specify: DEMAND ISCHEMIA
|
2.0%
1/50 • Adverse event data were collected through one year post transplant
|
0.00%
0/51 • Adverse event data were collected through one year post transplant
|
|
General disorders
General disorders - Other, specify: CHEST PAIN
|
4.0%
2/50 • Adverse event data were collected through one year post transplant
|
3.9%
2/51 • Adverse event data were collected through one year post transplant
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.0%
3/50 • Adverse event data were collected through one year post transplant
|
5.9%
3/51 • Adverse event data were collected through one year post transplant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place