NCT01272037 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Chemo and Endocrine Therapy
- description
- Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
- id
- FG001
- title
- Endocrine Therapy Alone
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 25
- group Id
- FG001
- num Subjects
- 28
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 12
- group Id
- FG001
- num Subjects
- 7
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 175
- group Id
- FG001
- num Subjects
- 93
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 70
- group Id
- FG001
- num Subjects
- 111
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 42
- group Id
- FG001
- num Subjects
- 41
- type
- Other reason
- reasons
- group Id
- FG000
- num Subjects
- 24
- group Id
- FG001
- num Subjects
- 19
- type
- Delinquent data
- reasons
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 29
- type
- Reason under review
- reasons
- group Id
- FG000
- num Subjects
- 626
- group Id
- FG001
- num Subjects
- 632
- type
- On treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 2511
- group Id
- FG001
- num Subjects
- 2507
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 1504
- group Id
- FG001
- num Subjects
- 1547
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1007
- group Id
- FG001
- num Subjects
- 960
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- 9383 participants were screened and 5083 were randomized to the trial: 2547 to the Chemo and Endocrine Therapy arm and 2536 to the Endocrine Therapy Alone arm. In the Chemo and Endocrine Therapy Arm, 36 were ineligible. In the Endocrine Therapy Alone arm, 29 were ineligible. Ultimately, 5018 participants were eligible in the participant flow: 2511 in the Chemo and Endocrine Therapy arm and 2507 in the Endocrine Therapy Alone arm.
Complete source fields
- groups
- description
- Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Chemo and Endocrine Therapy
- description
- Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
- id
- FG001
- title
- Endocrine Therapy Alone
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 25
- group Id
- FG001
- num Subjects
- 28
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 12
- group Id
- FG001
- num Subjects
- 7
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 175
- group Id
- FG001
- num Subjects
- 93
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 70
- group Id
- FG001
- num Subjects
- 111
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 42
- group Id
- FG001
- num Subjects
- 41
- type
- Other reason
- reasons
- group Id
- FG000
- num Subjects
- 24
- group Id
- FG001
- num Subjects
- 19
- type
- Delinquent data
- reasons
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 29
- type
- Reason under review
- reasons
- group Id
- FG000
- num Subjects
- 626
- group Id
- FG001
- num Subjects
- 632
- type
- On treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 2511
- group Id
- FG001
- num Subjects
- 2507
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 1504
- group Id
- FG001
- num Subjects
- 1547
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1007
- group Id
- FG001
- num Subjects
- 960
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- 9383 participants were screened and 5083 were randomized to the trial: 2547 to the Chemo and Endocrine Therapy arm and 2536 to the Endocrine Therapy Alone arm. In the Chemo and Endocrine Therapy Arm, 36 were ineligible. In the Endocrine Therapy Alone arm, 29 were ineligible. Ultimately, 5018 participants were eligible in the participant flow: 2511 in the Chemo and Endocrine Therapy arm and 2507 in the Endocrine Therapy Alone arm.
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Preserved source evidence · Not medical advice
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