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NCT01740427 · BASELINE

Baseline characteristics

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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

denoms
  1. counts
    1. group Id
      BG000
      value
      444
    2. group Id
      BG001
      value
      222
    3. group Id
      BG002
      value
      666
    units
    Participants
groups
  1. description
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    BG000
    title
    Palbociclib Plus Letrozole
  2. description
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    BG001
    title
    Placebo Plus Letrozole
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.6
          value
          61.7
        2. group Id
          BG001
          spread
          11.2
          value
          60.6
        3. group Id
          BG002
          spread
          10.8
          value
          61.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          444
        2. group Id
          BG001
          value
          222
        3. group Id
          BG002
          value
          666
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      444
    2. group Id
      BG001
      value
      222
    3. group Id
      BG002
      value
      666
    units
    Participants
groups
  1. description
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    BG000
    title
    Palbociclib Plus Letrozole
  2. description
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    BG001
    title
    Placebo Plus Letrozole
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.6
          value
          61.7
        2. group Id
          BG001
          spread
          11.2
          value
          60.6
        3. group Id
          BG002
          spread
          10.8
          value
          61.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          444
        2. group Id
          BG001
          value
          222
        3. group Id
          BG002
          value
          666
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice