TriangleNCT01951885 · OUTCOME
Cumulative Incidence of Participants With Acute GVHD
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 7- Day 100
What was measured
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.
Analysis population: participants who completed the study
Groups in this outcome
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.
| Group | Source count |
|---|---|
| Group A (Tacrolimus, Methotrexate) | 49 |
| Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | 47 |
Reported measurements
Grade 1-4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A (Tacrolimus, Methotrexate) | 37 | Not reported | 23 | 50 | Not reported |
| Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | 47 | Not reported | 32 | 60 | Not reported |
Grade 2-4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A (Tacrolimus, Methotrexate) | 27 | Not reported | 15 | 39 | Not reported |
| Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | 28 | Not reported | 16 | 41 | Not reported |
Grade 3-4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A (Tacrolimus, Methotrexate) | 4 | Not reported | 1 | 12 | Not reported |
| Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) | 13 | Not reported | 5 | 24 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Cumulative incidence methods are compared using the Gray test with a p-value \<0.05
- non Inferiority Type
- NON_INFERIORITY
- p Value
- <0.05
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Cumulative incidence methods are compared using the Gray test with a p-value \<0.05
- non Inferiority Type
- NON_INFERIORITY
- p Value
- <0.05
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23
- upper Limit
- 50
- value
- 37
- group Id
- OG001
- lower Limit
- 32
- upper Limit
- 60
- value
- 47
- title
- Grade 1-4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15
- upper Limit
- 39
- value
- 27
- group Id
- OG001
- lower Limit
- 16
- upper Limit
- 41
- value
- 28
- title
- Grade 2-4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 12
- value
- 4
- group Id
- OG001
- lower Limit
- 5
- upper Limit
- 24
- value
- 13
- title
- Grade 3-4
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 47
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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.
- id
- OG000
- title
- Group A (Tacrolimus, Methotrexate)
- description
- 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.
- id
- OG001
- title
- Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)
- param Type
- NUMBER
- population Description
- participants who completed the study
- reporting Status
- POSTED
- time Frame
- Day 7- Day 100
- title
- Cumulative Incidence of Participants With Acute GVHD
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice