Participant flow

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission · Source last updated 2025-07-08

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

groups

1. description

   Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.

   id

   FG000

   title

   Oral Azacitidine Plus Best Supportive Care

2. description

   Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.

   id

   FG001

   title

   Placebo Plus Best Supportive Care

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         151

      2. group Id

         FG001

         num Subjects

         181

      type

      Disease Relapse

   2. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         27

      type

      Other Reasons

   3. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         11

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrew Consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         238

      2. group Id

         FG001

         num Subjects

         234

      comment

      Treatment Phase

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         236

      2. group Id

         FG001

         num Subjects

         233

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         238

      2. group Id

         FG001

         num Subjects

         234

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

472 Participants Randomized, 469 participants treated

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Preserved source evidence · Not medical advice