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NCT03504397 · BASELINE

Baseline characteristics

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. · Source last updated 2026-05-04

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
      283
    2. group Id
      BG001
      value
      282
    3. group Id
      BG002
      value
      565
    units
    Participants
groups
  1. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    BG000
    title
    mFOLFOX6 + Zolbetuximab
  2. description
    Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
    id
    BG001
    title
    mFOLFOX6+Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          59.7
        2. group Id
          BG001
          spread
          13.0
          value
          58.8
        3. group Id
          BG002
          spread
          12.4
          value
          59.3
    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
          107
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          214
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          175
        3. group Id
          BG002
          value
          351
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          73
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          225
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          438
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          54
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          193
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          274
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          74
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          177
      title
      Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          195
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          388
      title
      Non- Asia
    param Type
    NUMBER
    title
    Region (Asia vs Non-Asia)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          438
      title
      0-2 metastatic sites
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          127
      title
      >=3 metastatic sites
    param Type
    NUMBER
    title
    Number of organs with metastatic sites
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          166
      title
      YES
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          399
      title
      NO
    param Type
    NUMBER
    title
    Prior Gastrectomy
    unit Of Measure
    Participants
population Description
Full analysis set(FAS) included all participants who were randomized to 1 of the treatment arms.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      283
    2. group Id
      BG001
      value
      282
    3. group Id
      BG002
      value
      565
    units
    Participants
groups
  1. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    BG000
    title
    mFOLFOX6 + Zolbetuximab
  2. description
    Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
    id
    BG001
    title
    mFOLFOX6+Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          59.7
        2. group Id
          BG001
          spread
          13.0
          value
          58.8
        3. group Id
          BG002
          spread
          12.4
          value
          59.3
    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
          107
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          214
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          175
        3. group Id
          BG002
          value
          351
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          73
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          225
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          438
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          54
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          193
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          274
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          74
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          177
      title
      Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          195
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          388
      title
      Non- Asia
    param Type
    NUMBER
    title
    Region (Asia vs Non-Asia)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          438
      title
      0-2 metastatic sites
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          127
      title
      >=3 metastatic sites
    param Type
    NUMBER
    title
    Number of organs with metastatic sites
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          166
      title
      YES
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          399
      title
      NO
    param Type
    NUMBER
    title
    Prior Gastrectomy
    unit Of Measure
    Participants
population Description
Full analysis set(FAS) included all participants who were randomized to 1 of the treatment arms.

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

Preserved source evidence · Not medical advice