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NCT00661999 · OUTCOME

Mean Increment in Hemoglobin Level at Week 7

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer · Source last updated 2011-05-17

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

Measure
MEAN
Unit
g/dL
Interval / dispersion
Standard Deviation
Time frame
Baseline and 7 weeks

What was measured

Value at 7 weeks minus value at baseline.

Groups in this outcome

DA + IV Iron

Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

DA + Oral Iron

Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

DA + Placebo

Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
DA + IV Iron164
DA + Oral Iron163
DA + Placebo163

Reported measurements

Source class 1
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DA + IV Iron1.31.35Not reportedNot reportedNot reported
DA + Oral Iron1.11.37Not reportedNot reportedNot reported
DA + Placebo1.21.35Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Description
    With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6639
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Description
    With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5660
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6639
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Description
    With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5660
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.35
        value
        1.3
      2. group Id
        OG001
        spread
        1.37
        value
        1.1
      3. group Id
        OG002
        spread
        1.35
        value
        1.2
denoms
  1. counts
    1. group Id
      OG000
      value
      164
    2. group Id
      OG001
      value
      163
    3. group Id
      OG002
      value
      163
    units
    Participants
description
Value at 7 weeks minus value at baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    OG000
    title
    DA + IV Iron
  2. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    OG001
    title
    DA + Oral Iron
  3. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    OG002
    title
    DA + Placebo
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline and 7 weeks
title
Mean Increment in Hemoglobin Level at Week 7
type
SECONDARY
unit Of Measure
g/dL

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Preserved source evidence · Not medical advice