Participant flow

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid · Source last updated 2024-03-15

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

groups

1. description

   Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days

   id

   FG000

   title

   AZ (Arimidex+Zoledronate)

2. description

   Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days

   id

   FG001

   title

   TZ (Tamoxifen+Zoledronate)

3. description

   Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days

   id

   FG002

   title

   AC (Arimidex Control)

4. description

   Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days

   id

   FG003

   title

   TC (Tamoxifen Control)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         20

      4. group Id

         FG003

         num Subjects

         18

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         14

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         5

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         8

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         450

      2. group Id

         FG001

         num Subjects

         450

      3. group Id

         FG002

         num Subjects

         453

      4. group Id

         FG003

         num Subjects

         450

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         415

      2. group Id

         FG001

         num Subjects

         409

      3. group Id

         FG002

         num Subjects

         403

      4. group Id

         FG003

         num Subjects

         405

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         50

      4. group Id

         FG003

         num Subjects

         45

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The first patient was randomized June 17, 1999, the last patient was randomized May 17, 2006. Randomization took place in 66 Austrian and 10 German clinical sites. In total, 1.803 patients were enrolled.

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Preserved source evidence · Not medical advice