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NCT03081689 · BASELINE

Baseline characteristics

Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients · Source last updated 2024-12-04

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
      46
    units
    Participants
groups
  1. description
    Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
    id
    BG000
    title
    Arm 1
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.9
          value
          63.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 2
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 3
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 4
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 5
    description
    ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability GRADES: ECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status Scale
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        title
        Former smoker (≥ 1 year)
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        Current smoker
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Never smoker
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cigarette Smoking History
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        Squamous
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        NOS/Undifferenciated
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        T1N2M0
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        T2N1M0
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        T2N2M0
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        T3N1M0
      5. measurements
        1. group Id
          BG000
          value
          13
        title
        T3N2M0
      6. measurements
        1. group Id
          BG000
          value
          9
        title
        T4N0M0
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        T1N1M0
    description
    8th ed.TNM for Lung Cancer Primary tumor (T) T0 means there is no evidence of a tumor T1-T4 describe the size \& location of the tumor on a scale of 1 to 4. A larger tumor or a tumor that has grown deeper into nearby tissue will get a higher number Distant metastasis (M) M0:Cancer has not spread to other parts of the body M1:Cancer has spread to other parts of the body Regional lymph nodes (N) N1: Metastasis in ipsilateral peribronchial or ipsilateral hilar lymph \& intrapulmonary nodes N2:Metastasis in ipsilateral mediastinal or subcarinal lymph node N3:Metastasis in contralateral node
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor node, metastasis staging classification
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      46
    units
    Participants
groups
  1. description
    Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
    id
    BG000
    title
    Arm 1
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.9
          value
          63.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 2
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 3
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 4
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        ECOG 5
    description
    ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability GRADES: ECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status Scale
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        title
        Former smoker (≥ 1 year)
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        Current smoker
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Never smoker
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cigarette Smoking History
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        Squamous
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        NOS/Undifferenciated
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        T1N2M0
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        T2N1M0
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        T2N2M0
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        T3N1M0
      5. measurements
        1. group Id
          BG000
          value
          13
        title
        T3N2M0
      6. measurements
        1. group Id
          BG000
          value
          9
        title
        T4N0M0
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        T1N1M0
    description
    8th ed.TNM for Lung Cancer Primary tumor (T) T0 means there is no evidence of a tumor T1-T4 describe the size \& location of the tumor on a scale of 1 to 4. A larger tumor or a tumor that has grown deeper into nearby tissue will get a higher number Distant metastasis (M) M0:Cancer has not spread to other parts of the body M1:Cancer has spread to other parts of the body Regional lymph nodes (N) N1: Metastasis in ipsilateral peribronchial or ipsilateral hilar lymph \& intrapulmonary nodes N2:Metastasis in ipsilateral mediastinal or subcarinal lymph node N3:Metastasis in contralateral node
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor node, metastasis staging classification
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice