Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment	At day 42 after initiation of treatment	The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.
Secondary	Prednisone-associated Toxicity as Assessed by Hyperglycemia	Baseline and then through 42 days after starting treatment	Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.
Secondary	Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)	Baseline and through 100 days of treatment	The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.
Secondary	Prednisone-associated Toxicity as Assessed by Myopathy	Baseline and then weekly until 42 days after starting treatment	Assessed 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.
Secondary	Prednisone-associated Toxicity as Assessed by Hypertension	Baseline and then through 42 days after starting treatment	The 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.
Secondary	Prednisone-associated Toxicity as Assessed by Quality of Life	Baseline and then every other week until 42 days after starting treatment	Patients 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.
Secondary	Non-relapse Mortality	At 12 months after the start of prednisone therapy	Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.
Secondary	Recurrent or Progressive Malignancy	At 12 months after the start of prednisone therapy	Percentage of relapse estimated by cumulative incidence methods
Secondary	Progression to Grade III-IV Acute GVHD	At approximately 100 days after transplant	Diagnosed 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.
Secondary	Secondary Therapy for Acute GVHD Beyond Prednisone	At approximately 100 days after transplant	This 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.
Secondary	Chronic Extensive GVHD	At 12 months after the start of prednisone therapy	Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods
Secondary	Overall Survival	At 12 months after the start of prednisone therapy	Percentage of patients surviving as estimated by Kaplan-Meier.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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