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NCT01953692 · BASELINE

Baseline characteristics

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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
      28
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      31
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      22
    7. group Id
      BG006
      value
      42
    8. group Id
      BG007
      value
      13
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      197
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    BG000
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
  2. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG001
    title
    Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
  3. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG002
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
  4. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG003
    title
    Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
  5. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG004
    title
    Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
  6. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    BG005
    title
    Cohort 4C: R/R Follicular Lymphoma (FL)
  7. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    BG006
    title
    Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
  8. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
    id
    BG007
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
  9. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
    id
    BG008
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.4
          value
          71.4
        2. group Id
          BG001
          spread
          7.3
          value
          67.9
        3. group Id
          BG002
          spread
          12.1
          value
          34.4
        4. group Id
          BG003
          spread
          12.0
          value
          35.2
        5. group Id
          BG004
          spread
          10.9
          value
          49.3
        6. group Id
          BG005
          spread
          9.2
          value
          62.1
        7. group Id
          BG006
          spread
          11.5
          value
          63.8
        8. group Id
          BG007
          spread
          13.3
          value
          62.6
        9. group Id
          BG008
          spread
          8.4
          value
          65.2
        10. group Id
          BG009
          spread
          17.6
          value
          57.3
    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
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          83
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          114
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          40
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          164
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          25
        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
          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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          7
        title
        Asian
      3. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          176
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      28
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      31
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      22
    7. group Id
      BG006
      value
      42
    8. group Id
      BG007
      value
      13
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      197
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    BG000
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
  2. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG001
    title
    Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
  3. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG002
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
  4. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG003
    title
    Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
  5. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    BG004
    title
    Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
  6. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    BG005
    title
    Cohort 4C: R/R Follicular Lymphoma (FL)
  7. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    BG006
    title
    Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
  8. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
    id
    BG007
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
  9. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
    id
    BG008
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.4
          value
          71.4
        2. group Id
          BG001
          spread
          7.3
          value
          67.9
        3. group Id
          BG002
          spread
          12.1
          value
          34.4
        4. group Id
          BG003
          spread
          12.0
          value
          35.2
        5. group Id
          BG004
          spread
          10.9
          value
          49.3
        6. group Id
          BG005
          spread
          9.2
          value
          62.1
        7. group Id
          BG006
          spread
          11.5
          value
          63.8
        8. group Id
          BG007
          spread
          13.3
          value
          62.6
        9. group Id
          BG008
          spread
          8.4
          value
          65.2
        10. group Id
          BG009
          spread
          17.6
          value
          57.3
    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
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          83
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          114
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          40
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          164
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          25
        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
          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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          7
        title
        Asian
      3. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          176
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study treatment.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice