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NCT00661999 · OUTCOME

Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
16 Weeks

What was measured

Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb \>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.

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

Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DA + IV Iron114Not reportedNot reportedNot reportedNot reported
DA + Oral Iron109Not reportedNot reportedNot reportedNot reported
DA + Placebo106Not reportedNot reportedNot reportedNot reported
No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DA + IV Iron50Not reportedNot reportedNot reportedNot reported
DA + Oral Iron54Not reportedNot reportedNot reportedNot reported
DA + Placebo57Not reportedNot 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 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.39
    statistical Method
    Fisher Exact
    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 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.73
    statistical Method
    Fisher Exact
    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 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.39
    statistical Method
    Fisher Exact
    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 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.73
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        114
      2. group Id
        OG001
        value
        109
      3. group Id
        OG002
        value
        106
    title
    Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        57
    title
    No
denoms
  1. counts
    1. group Id
      OG000
      value
      164
    2. group Id
      OG001
      value
      163
    3. group Id
      OG002
      value
      163
    units
    Participants
description
Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb \>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
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
NUMBER
reporting Status
POSTED
time Frame
16 Weeks
title
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice