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NCT01566721 · BASELINE

Baseline characteristics

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer · Source last updated 2021-04-27

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
      1867
    2. group Id
      BG001
      value
      710
    3. group Id
      BG002
      value
      2577
    units
    Participants
groups
  1. description
    Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
    id
    BG000
    title
    Cohort A: SC Herceptin by Needle/Syringe
  2. description
    Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
    id
    BG001
    title
    Cohort B: SC Herceptin by SID
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.01
          value
          54.0
        2. group Id
          BG001
          spread
          11.32
          value
          53.0
        3. group Id
          BG002
          spread
          11.83
          value
          53.7
    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
          1863
        2. group Id
          BG001
          value
          710
        3. group Id
          BG002
          value
          2573
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population: All participants enrolled into the study regardless of whether treatment was received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1867
    2. group Id
      BG001
      value
      710
    3. group Id
      BG002
      value
      2577
    units
    Participants
groups
  1. description
    Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
    id
    BG000
    title
    Cohort A: SC Herceptin by Needle/Syringe
  2. description
    Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
    id
    BG001
    title
    Cohort B: SC Herceptin by SID
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.01
          value
          54.0
        2. group Id
          BG001
          spread
          11.32
          value
          53.0
        3. group Id
          BG002
          spread
          11.83
          value
          53.7
    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
          1863
        2. group Id
          BG001
          value
          710
        3. group Id
          BG002
          value
          2573
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population: All participants enrolled into the study regardless of whether treatment was received.

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

Preserved source evidence · Not medical advice