Participant flow

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.

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

   FG000

   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

   FG001

   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

   FG002

   title

   DA + Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         8

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         3

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         23

      type

      Other Reasons

   4. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         23

      3. group Id

         FG002

         num Subjects

         14

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Alternative Treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         9

      type

      Other Medical Problems

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         164

      2. group Id

         FG001

         num Subjects

         163

      3. group Id

         FG002

         num Subjects

         163

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         105

      2. group Id

         FG001

         num Subjects

         113

      3. group Id

         FG002

         num Subjects

         106

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         59

      2. group Id

         FG001

         num Subjects

         50

      3. group Id

         FG002

         num Subjects

         57

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eight patients canceled before the first dose of darbepoetin alfa (DA) (3 DA + Intravenously (IV) Iron, 3 DA + Oral Iron and 2 DA + Placebo); and 4 patients were ineligible (2 DA + Oral Iron, 2 DA + Placebo). These 12 patients were excluded from all analysis.

recruitment Details

Five-hundred and two (502) participants were recruited between February 2006 and December 2008 at Mayo Clinic Cancer Research Consortium (MCCRC) sites.

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Preserved source evidence · Not medical advice