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NCT01074047 · OUTCOME

Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) · Source last updated 2017-08-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Day 1 (randomization) to 40 months

What was measured

HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.

Analysis population: HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.

Groups in this outcome

Azacitidine (AZA)

Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.

Conventional Care Regimens (CCR)

CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Azacitidine (AZA)157
Conventional Care Regimens (CCR)134

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine (AZA)139Not reportedNot reportedNot reportedNot reported
Conventional Care Regimens (CCR)111Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        139
      2. group Id
        OG001
        value
        111
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      134
    units
    Participants
description
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
groups
  1. description
    Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    OG000
    title
    Azacitidine (AZA)
  2. description
    CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
    id
    OG001
    title
    Conventional Care Regimens (CCR)
param Type
NUMBER
population Description
HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.
reporting Status
POSTED
time Frame
Day 1 (randomization) to 40 months
title
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice