NCT02513394 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- 4 years
What was measured
Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.
Groups in this outcome
Palbociclib Plus Endocrine Therapy (Arm A)
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
Endocrine Therapy Alone (Arm B)
Standard adjuvant endocrine therapy for a duration of at least 5 years.
| Group | Source count |
|---|---|
| Palbociclib Plus Endocrine Therapy (Arm A) | 2884 |
| Endocrine Therapy Alone (Arm B) | 2877 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib Plus Endocrine Therapy (Arm A) | 93.8 | Not reported | Not reported | Not reported | Not reported |
| Endocrine Therapy Alone (Arm B) | 95.2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.78
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.32
Complete source fields
- analyses
- ci Lower Limit
- 0.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.78
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.32
- classes
- categories
- measurements
- group Id
- OG000
- value
- 93.8
- group Id
- OG001
- value
- 95.2
- denoms
- counts
- group Id
- OG000
- value
- 2884
- group Id
- OG001
- value
- 2877
- units
- Participants
- description
- Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.
- groups
- description
- Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
- id
- OG000
- title
- Palbociclib Plus Endocrine Therapy (Arm A)
- description
- Standard adjuvant endocrine therapy for a duration of at least 5 years.
- id
- OG001
- title
- Endocrine Therapy Alone (Arm B)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 4 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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