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NCT01041404 · BASELINE

Baseline characteristics

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer · Source last updated 2014-11-05

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
      290
    2. group Id
      BG001
      value
      294
    3. group Id
      BG002
      value
      584
    units
    Participants
groups
  1. description
    Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
    id
    BG000
    title
    Fluoropyrimidine/Cisplatin (FP)
  2. description
    Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
    id
    BG001
    title
    Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.22
          value
          58.5
        2. group Id
          BG001
          spread
          10.75
          value
          59.4
        3. group Id
          BG002
          spread
          10.99
          value
          59.0
    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
          72
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          140
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          444
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      290
    2. group Id
      BG001
      value
      294
    3. group Id
      BG002
      value
      584
    units
    Participants
groups
  1. description
    Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
    id
    BG000
    title
    Fluoropyrimidine/Cisplatin (FP)
  2. description
    Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
    id
    BG001
    title
    Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.22
          value
          58.5
        2. group Id
          BG001
          spread
          10.75
          value
          59.4
        3. group Id
          BG002
          spread
          10.99
          value
          59.0
    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
          72
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          140
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          444
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment.

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Preserved source evidence · Not medical advice