Participant flow

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants · Source last updated 2021-05-26

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

groups

1. description

   Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).

   id

   FG000

   title

   Zoledronic Acid Every 12 Weeks

2. description

   Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).

   id

   FG001

   title

   Zoledronic Acid Every 4 Weeks or 12 Weeks

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Abnormal Laboratory Value(s)

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Abnormal Test Procedure Result(s)

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         5

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Administrative Problems

   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

         79

      2. group Id

         FG001

         num Subjects

         42

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         19

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 121 participants with Advanced Multiple Myeloma were enrolled in this study. By study design, any participants who had a Skeletal-related Event (SRE) in Zoledronic Acid Every 12 Weeks group was switched to Zoledronic Acid Every 4 Weeks or 12 Weeks group and reported as Zoledronic Acid Every 4 Weeks or 12 Weeks group, respectively.

recruitment Details

This study was conducted at 67 centers in the United States (US) from 07 November 2007 to 03 April 2012.

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Preserved source evidence · Not medical advice