Trial Outcomes & Findings for Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease (NCT NCT00929695)
NCT ID: NCT00929695
Last Updated: 2017-08-21
Results Overview
The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
164 participants
Primary outcome timeframe
At day 42 after initiation of treatment
Results posted on
2017-08-21
Participant Flow
Participant milestones
| Measure |
Group A (Low-dose)
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
|
Group B (Standard-dose)
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
83
|
|
Overall Study
COMPLETED
|
73
|
77
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Group A (Low-dose)
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
|
Group B (Standard-dose)
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
discharge home
|
4
|
3
|
|
Overall Study
incorrect stratification
|
2
|
0
|
Baseline Characteristics
Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Baseline characteristics by cohort
| Measure |
Group A (Low-dose)
n=73 Participants
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
|
Group B (Standard-dose)
n=77 Participants
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 42 after initiation of treatmentPopulation: From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.
The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=44 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=47 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
n=29 Participants
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
n=30 Participants
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
|
22.2 milligrams per kilogram
Standard Deviation 13.7
|
27.1 milligrams per kilogram
Standard Deviation 12.7
|
38.4 milligrams per kilogram
Standard Deviation 14.1
|
41.3 milligrams per kilogram
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline and then through 42 days after starting treatmentImpact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Prednisone-associated Toxicity as Assessed by Hyperglycemia
|
140 mg/dL
Standard Error 7.4
|
142 mg/dL
Standard Error 12.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and through 100 days of treatmentThe total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
|
52 percentage of participants
|
53 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and then weekly until 42 days after starting treatmentAssessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Prednisone-associated Toxicity as Assessed by Myopathy
|
-0.18 units on a scale
Interval -1.5 to 1.5
|
-0.18 units on a scale
Interval -1.5 to 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and then through 42 days after starting treatmentThe number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Prednisone-associated Toxicity as Assessed by Hypertension
|
-0.29 medications
Interval -0.5 to 0.5
|
-0.24 medications
Interval -0.5 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and then every other week until 42 days after starting treatmentPatients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Prednisone-associated Toxicity as Assessed by Quality of Life
|
-2.3 units on a scale
Interval -5.0 to 5.0
|
-1.9 units on a scale
Interval -5.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 months after the start of prednisone therapyNon-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Non-relapse Mortality
|
15 percentage of participants
|
16 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 months after the start of prednisone therapyPercentage of relapse estimated by cumulative incidence methods
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Recurrent or Progressive Malignancy
|
21 percentage of participants
|
21 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At approximately 100 days after transplantDiagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Progression to Grade III-IV Acute GVHD
|
6 percentage of participants
|
13 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At approximately 100 days after transplantThis includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Secondary Therapy for Acute GVHD Beyond Prednisone
|
23 percentage of participants
|
7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 months after the start of prednisone therapyPercentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Chronic Extensive GVHD
|
47 percentage of participants
|
54 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 months after the start of prednisone therapyPercentage of patients surviving as estimated by Kaplan-Meier.
Outcome measures
| Measure |
Grade IIa GVHD; 0.5 mg/kg/d Prednisone
n=79 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIa GVHD; 1.0 mg/kg/d Prednisone
n=83 Participants
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
|
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
|
|---|---|---|---|---|
|
Overall Survival
|
77 percentage of participants
|
77 percentage of participants
|
—
|
—
|
Adverse Events
Arm I (Low-dose)
Serious events: 38 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Standard-dose)
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Low-dose)
n=81 participants at risk
Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.
prednisone: immunosuppressive drug
methylprednisolone: immunosuppressive drug
questionnaire administration: Ancillary studies
|
Arm II (Standard-dose)
n=83 participants at risk
Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.
prednisone: immunosuppressive drug
methylprednisolone: immunosuppressive drug
questionnaire administration: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
peripheral edema
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
palpitations
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Immune system disorders
graft versus host disease
|
9.9%
8/81 • Number of events 9
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Nervous system disorders
lethargy
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Infections and infestations
fever/infection
|
16.0%
13/81 • Number of events 14
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
13.3%
11/83 • Number of events 13
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
orthostatic hypotension
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Gastrointestinal disorders
gastroesophageal relux disease
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Blood and lymphatic system disorders
platelet infusion reaction
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Blood and lymphatic system disorders
relapse of hematological disease
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
4.8%
4/83 • Number of events 4
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Social circumstances
suicide
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Respiratory, thoracic and mediastinal disorders
adult respiratory distress syndrome
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Musculoskeletal and connective tissue disorders
temporomandibular joint disorder
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
chest pain
|
1.2%
1/81 • Number of events 3
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Skin and subcutaneous tissue disorders
parotitis
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Nervous system disorders
mental status changes
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
2.4%
2/83 • Number of events 2
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Blood and lymphatic system disorders
hematopoietic graft failure
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
congestive heart failure
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Gastrointestinal disorders
splenomagaly
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Hepatobiliary disorders
elevated liver function tests
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Cardiac disorders
hypertension
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Gastrointestinal disorders
nausea/vomiting
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Respiratory, thoracic and mediastinal disorders
diffuse alveolar hemorrhage
|
0.00%
0/81
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
1.2%
1/83 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
General disorders
trauma/fall
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Musculoskeletal and connective tissue disorders
weakness
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
|
Gastrointestinal disorders
colonic pneumatosis
|
1.2%
1/81 • Number of events 1
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
0.00%
0/83
Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place