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NCT00661999 · OUTCOME

Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16

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
fL
Interval / dispersion
Standard Deviation
Time frame
Baseline, 7 weeks and 16 weeks

What was measured

MCV is a measure of the average red blood cell volume.

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

Baseline
Values in fL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DA + IV Iron90.05.92Not reportedNot reportedNot reported
DA + Oral Iron88.59.05Not reportedNot reportedNot reported
DA + Placebo90.18.19Not reportedNot reportedNot reported
Week 7
Values in fL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DA + IV Iron93.09.21Not reportedNot reportedNot reported
DA + Oral Iron92.39.70Not reportedNot reportedNot reported
DA + Placebo92.88.56Not reportedNot reportedNot reported
Week 16
Values in fL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DA + IV Iron94.011.37Not reportedNot reportedNot reported
DA + Oral Iron94.47.55Not reportedNot reportedNot reported
DA + Placebo92.39.31Not 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 Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1137
    p Value Comment
    Test comparison for baseline level.
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8042
    p Value Comment
    Test comparison for week 7 level.
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  3. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2016
    p Value Comment
    Test comparison for week 16 level.
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1137
    p Value Comment
    Test comparison for baseline level.
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8042
    p Value Comment
    Test comparison for week 7 level.
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  3. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2016
    p Value Comment
    Test comparison for week 16 level.
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.92
        value
        90.0
      2. group Id
        OG001
        spread
        9.05
        value
        88.5
      3. group Id
        OG002
        spread
        8.19
        value
        90.1
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.21
        value
        93.0
      2. group Id
        OG001
        spread
        9.70
        value
        92.3
      3. group Id
        OG002
        spread
        8.56
        value
        92.8
    title
    Week 7
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.37
        value
        94.0
      2. group Id
        OG001
        spread
        7.55
        value
        94.4
      3. group Id
        OG002
        spread
        9.31
        value
        92.3
    title
    Week 16
denoms
  1. counts
    1. group Id
      OG000
      value
      164
    2. group Id
      OG001
      value
      163
    3. group Id
      OG002
      value
      163
    units
    Participants
description
MCV is a measure of the average red blood cell volume.
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, 7 weeks and 16 weeks
title
Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16
type
SECONDARY
unit Of Measure
fL

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Preserved source evidence · Not medical advice