Participant flow

Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors · Source last updated 2025-04-23

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

groups

1. description

   Patients receive low-dose carvedilol orally (PO) once daily (QD) or twice daily (BID) for 24 months.

   id

   FG000

   title

   Arm I (Carvedilol)

2. description

   Patients receive placebo PO QD or BID for 24 months.

   id

   FG001

   title

   Arm II (Placebo)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Pregnancy

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         20

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Relapse

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      type

      Cardiac Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         89

      2. group Id

         FG001

         num Subjects

         93

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         75

      2. group Id

         FG001

         num Subjects

         76

      comment

      31 participants who did not have a second timepoint assessment of echocardiography were excluded, resulting in 151 analyzable participants.

      type

      2nd Timepoint Assessment of Echocardiology Required to be Analyzable

   3. achievements

      1. group Id

         FG000

         num Subjects

         58

      2. group Id

         FG001

         num Subjects

         55

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         38

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

196 pts were enrolled (109 pts enrolled with Childrens Oncology Group (COG) and 87 pts enrolled on a pilot study at City of Hope (COH) 182 of those pts started tx (14 excluded: 6 ineligible and 8 pts started tx). (The (109) enrollment number in the protocol section reflects the number of pts enrolled on the COG portion of the study. Per Section 9.2 of the protocol (pt accrual and expected duration of the trial), 87 pts had already been accrued through a different mechanism the pilot study)

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Preserved source evidence · Not medical advice