Participant flow

A Multiple Myeloma Trial in Patients With Bone Metastases · Source last updated 2011-06-29

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 zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.

   id

   FG000

   title

   15 - Minute Infusion

2. description

   Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.

   id

   FG001

   title

   30 - Minute Infusion

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         8

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         14

      type

      Abnormal laboratory value(s)

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         4

      type

      Condition no longer requires study drug

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         15

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         7

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         13

      type

      Administrative problems

   9. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   milestones

   1. achievements

      1. comment

         2 Participants in the 15-minute infusion group did not receive study drug.

         group Id

         FG000

         num Subjects

         90

      2. comment

         1 Participants in the 30-minute infusion group did not receive study drug.

         group Id

         FG001

         num Subjects

         89

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         88

      2. group Id

         FG001

         num Subjects

         88

      type

      Safety Population (Including Site 74)

   3. achievements

      1. comment

         Because of GCP violations at Site 74, post-baseline data for 3 patients in this arm were excluded.

         group Id

         FG000

         num Subjects

         85

      2. comment

         Because of GCP violations at Site 74, post-baseline data for 4 patients in this arm were excluded.

         group Id

         FG001

         num Subjects

         84

      type

      Safety Population (Excluding Site 74)

   4. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         17

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         75

      2. group Id

         FG001

         num Subjects

         72

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice