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NCT00416624 · OUTCOME

Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL

Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy · Source last updated 2017-02-10

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
16 weeks

What was measured

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule

Analysis population: All patients that were evaluable per protocol and had hemoglobin levels data.

Groups in this outcome

Epoetin Alfa - 40k Weekly

Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)

Epoetin Alfa - 80k Every 3 Weeks

Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)

Epoetin Alfa - 120k Every 3 Weeks

Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)

Darbepoetin Alfa - 500 mcg Every 3 Weeks

Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)

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

Analysis denominator · Participants

GroupSource count
Epoetin Alfa - 40k Weekly61
Epoetin Alfa - 80k Every 3 Weeks60
Epoetin Alfa - 120k Every 3 Weeks58
Darbepoetin Alfa - 500 mcg Every 3 Weeks57

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Epoetin Alfa - 40k Weekly32Not reported2837Not reported
Epoetin Alfa - 80k Every 3 Weeks50Not reported3568Not reported
Epoetin Alfa - 120k Every 3 Weeks49Not reported3577Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks49Not reported3564Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    >0.13
    statistical Method
    Fisher Exact
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    >0.13
    statistical Method
    Fisher Exact
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28
        upper Limit
        37
        value
        32
      2. group Id
        OG001
        lower Limit
        35
        upper Limit
        68
        value
        50
      3. group Id
        OG002
        lower Limit
        35
        upper Limit
        77
        value
        49
      4. group Id
        OG003
        lower Limit
        35
        upper Limit
        64
        value
        49
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      58
    4. group Id
      OG003
      value
      57
    units
    Participants
description
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
    id
    OG000
    title
    Epoetin Alfa - 40k Weekly
  2. description
    Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    OG001
    title
    Epoetin Alfa - 80k Every 3 Weeks
  3. description
    Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    OG002
    title
    Epoetin Alfa - 120k Every 3 Weeks
  4. description
    Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    OG003
    title
    Darbepoetin Alfa - 500 mcg Every 3 Weeks
param Type
MEDIAN
population Description
All patients that were evaluable per protocol and had hemoglobin levels data.
reporting Status
POSTED
time Frame
16 weeks
title
Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL
type
SECONDARY
unit Of Measure
days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice