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NCT00441337 · BASELINE

Baseline characteristics

A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies · Source last updated 2015-02-20

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      39
    units
    Participants
groups
  1. description
    0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG000
    title
    0.3 mg/kg Nivolumab
  2. description
    1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG001
    title
    1 mg/kg Nivolumab
  3. description
    3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG002
    title
    3 mg/kg Nivolumab
  4. description
    10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG003
    title
    10 mg/kg Nivolumab
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.7
          value
          56.5
        2. group Id
          BG001
          spread
          9.4
          value
          68.3
        3. group Id
          BG002
          spread
          10.4
          value
          61.0
        4. group Id
          BG003
          spread
          10.0
          value
          63.2
        5. group Id
          BG004
          spread
          9.7
          value
          62.6
    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
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          22
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          29
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
      title
      Black
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          39
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          88
          upper Limit
          136
          value
          96.8
        2. group Id
          BG001
          lower Limit
          62
          upper Limit
          80
          value
          73.9
        3. group Id
          BG002
          lower Limit
          55
          upper Limit
          98
          value
          81.9
        4. group Id
          BG003
          lower Limit
          56
          upper Limit
          118
          value
          81.3
        5. group Id
          BG004
          lower Limit
          55
          upper Limit
          136
          value
          81.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Body Weight in kilograms (kg)
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.4
          upper Limit
          6.8
          value
          3.7
        2. group Id
          BG001
          lower Limit
          1.5
          upper Limit
          14.0
          value
          2.7
        3. group Id
          BG002
          lower Limit
          0.7
          upper Limit
          11.4
          value
          5.6
        4. group Id
          BG003
          lower Limit
          1.0
          upper Limit
          19.8
          value
          4.1
        5. group Id
          BG004
          lower Limit
          0.7
          upper Limit
          19.8
          value
          3.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since initial diagnosis (years)
    unit Of Measure
    Years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
      title
      Prostate Cancer
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          10
      title
      Melanoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      Non-small cell lung cancer
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
      title
      Renal cell cancer
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          14
      title
      Colorectal cancer
    param Type
    NUMBER
    title
    Type of Malignancy
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          38
      title
      Stage IV
    description
    The investigator reported the screening malignancy stage for each type of cancer using the American Joint Committee on Cancer Classification (Stages I, II, III, and IV).
    param Type
    NUMBER
    title
    Stage of Malignancy at Screening Diagnosis
    unit Of Measure
    participants
population Description
All participants who received at least 1 dose or any partial dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      39
    units
    Participants
groups
  1. description
    0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG000
    title
    0.3 mg/kg Nivolumab
  2. description
    1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG001
    title
    1 mg/kg Nivolumab
  3. description
    3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG002
    title
    3 mg/kg Nivolumab
  4. description
    10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
    id
    BG003
    title
    10 mg/kg Nivolumab
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.7
          value
          56.5
        2. group Id
          BG001
          spread
          9.4
          value
          68.3
        3. group Id
          BG002
          spread
          10.4
          value
          61.0
        4. group Id
          BG003
          spread
          10.0
          value
          63.2
        5. group Id
          BG004
          spread
          9.7
          value
          62.6
    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
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          22
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          29
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
      title
      Black
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          39
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          88
          upper Limit
          136
          value
          96.8
        2. group Id
          BG001
          lower Limit
          62
          upper Limit
          80
          value
          73.9
        3. group Id
          BG002
          lower Limit
          55
          upper Limit
          98
          value
          81.9
        4. group Id
          BG003
          lower Limit
          56
          upper Limit
          118
          value
          81.3
        5. group Id
          BG004
          lower Limit
          55
          upper Limit
          136
          value
          81.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Body Weight in kilograms (kg)
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.4
          upper Limit
          6.8
          value
          3.7
        2. group Id
          BG001
          lower Limit
          1.5
          upper Limit
          14.0
          value
          2.7
        3. group Id
          BG002
          lower Limit
          0.7
          upper Limit
          11.4
          value
          5.6
        4. group Id
          BG003
          lower Limit
          1.0
          upper Limit
          19.8
          value
          4.1
        5. group Id
          BG004
          lower Limit
          0.7
          upper Limit
          19.8
          value
          3.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since initial diagnosis (years)
    unit Of Measure
    Years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
      title
      Prostate Cancer
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          10
      title
      Melanoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      Non-small cell lung cancer
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
      title
      Renal cell cancer
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          14
      title
      Colorectal cancer
    param Type
    NUMBER
    title
    Type of Malignancy
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          38
      title
      Stage IV
    description
    The investigator reported the screening malignancy stage for each type of cancer using the American Joint Committee on Cancer Classification (Stages I, II, III, and IV).
    param Type
    NUMBER
    title
    Stage of Malignancy at Screening Diagnosis
    unit Of Measure
    participants
population Description
All participants who received at least 1 dose or any partial dose of study drug.

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