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NCT01871805 · BASELINE

Baseline characteristics

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2018-08-21

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
      7
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      13
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      13
    6. group Id
      BG005
      value
      87
    7. group Id
      BG006
      value
      134
    units
    Participants
groups
  1. description
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG000
    title
    Alectinib 300 mg (Fasted): Phase I
  2. description
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG001
    title
    Alectinib 460 mg (Fed): Phase I
  3. description
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG002
    title
    Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
  4. description
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG003
    title
    Alectinib 760 mg (Fed): Phase I
  5. description
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG004
    title
    Alectinib 900 mg (Fed): Phase I (20/40/150 mg)
  6. description
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG005
    title
    Alectinib 600 mg (Fed): Phase II
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. 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
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          71
        7. group Id
          BG006
          value
          113
        title
        Between 18 and 65 years
      3. 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
          3
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          21
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          48
        7. group Id
          BG006
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          39
        7. group Id
          BG006
          value
          66
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population included all participants who received any dose of alectinib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      13
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      13
    6. group Id
      BG005
      value
      87
    7. group Id
      BG006
      value
      134
    units
    Participants
groups
  1. description
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG000
    title
    Alectinib 300 mg (Fasted): Phase I
  2. description
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG001
    title
    Alectinib 460 mg (Fed): Phase I
  3. description
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG002
    title
    Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
  4. description
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG003
    title
    Alectinib 760 mg (Fed): Phase I
  5. description
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG004
    title
    Alectinib 900 mg (Fed): Phase I (20/40/150 mg)
  6. description
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    BG005
    title
    Alectinib 600 mg (Fed): Phase II
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. 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
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          71
        7. group Id
          BG006
          value
          113
        title
        Between 18 and 65 years
      3. 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
          3
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          21
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          48
        7. group Id
          BG006
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          39
        7. group Id
          BG006
          value
          66
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population included all participants who received any dose of alectinib.

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Preserved source evidence · Not medical advice