Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00416624 · OUTCOME

The Percentage of Participants Reported Grade 3 or 4 Adverse Events

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
16 weeks

What was measured

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Analysis population: All patients that were evaluable per protocol and reported at least one value after baseline.

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 Weekly60
Epoetin Alfa - 80k Every 3 Weeks60
Epoetin Alfa - 120k Every 3 Weeks58
Darbepoetin Alfa - 500 mcg Every 3 Weeks55

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epoetin Alfa - 40k Weekly22Not reportedNot reportedNot reportedNot reported
Epoetin Alfa - 80k Every 3 Weeks22Not reportedNot reportedNot reportedNot reported
Epoetin Alfa - 120k Every 3 Weeks17Not reportedNot reportedNot reportedNot reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks13Not reportedNot reportedNot reportedNot 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 Description
    With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    >0.56
    statistical Method
    Fisher Exact
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    >0.56
    statistical Method
    Fisher Exact
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      58
    4. group Id
      OG003
      value
      55
    units
    Participants
description
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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
NUMBER
population Description
All patients that were evaluable per protocol and reported at least one value after baseline.
reporting Status
POSTED
time Frame
16 weeks
title
The Percentage of Participants Reported Grade 3 or 4 Adverse Events
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice