Participant flow

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML · Source last updated 2014-11-03

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

groups

1. description

   Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.

   id

   FG000

   title

   Dasatinib 140 mg QD

2. description

   Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.

   id

   FG001

   title

   Dasatinib 70 mg BID

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death prior to starting treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      SAE prior to starting treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         306

      2. group Id

         FG001

         num Subjects

         305

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         305

      2. group Id

         FG001

         num Subjects

         304

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Randomized

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         22

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         141

      2. group Id

         FG001

         num Subjects

         122

      type

      Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         9

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         59

      2. group Id

         FG001

         num Subjects

         58

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         62

      2. group Id

         FG001

         num Subjects

         80

      type

      Study Drug Toxicity

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Unknown (case report form lost)

   milestones

   1. achievements

      1. comment

         1 participant randomized to QD but received BID in error. 304 represents actual QD treatment.

         group Id

         FG000

         num Subjects

         304

      2. comment

         1 participant randomized to QD but received BID in error. 305 represents actual BID treatment.

         group Id

         FG001

         num Subjects

         305

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         304

      2. group Id

         FG001

         num Subjects

         305

      type

      NOT COMPLETED

   title

   Treated With Study Drug

pre Assignment Details

638 participants were enrolled; 27 were not randomized due to: adverse event (1), death (5), other (5), poor/noncompliance (1), no longer met criteria (13), withdrew consent (2). A total of 611 were randomized to treatment; 609 were treated: 2 randomized but not treated due to death (1) and serious adverse event (1).

recruitment Details

Study started June 2005; recruitment completed March 2006; study ended June 2013 (Year 7) when the study closed and all participants were off study treatment. Those participants who were resistant or intolerant to prior imatinib were enrolled.

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Preserved source evidence · Not medical advice