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NCT01802632 · BASELINE

Baseline characteristics

AZD9291 First Time In Patients Ascending Dose Study · Source last updated 2026-04-20

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
      201
    2. group Id
      BG001
      value
      31
    3. group Id
      BG002
      value
      271
    4. group Id
      BG003
      value
      60
    5. group Id
      BG004
      value
      12
    6. group Id
      BG005
      value
      28
    7. group Id
      BG006
      value
      603
    units
    Participants
groups
  1. description
    Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
    id
    BG000
    title
    AZD9291 80mg Extension
  2. description
    Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
    id
    BG001
    title
    Dose Escalation
  3. description
    Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
    id
    BG002
    title
    Dose Expansion
  4. description
    Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
    id
    BG003
    title
    First Line
  5. description
    US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
    id
    BG004
    title
    80mg Tablet
  6. description
    Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
    id
    BG005
    title
    Japan Cytology
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          89
      title
      <50 Years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          142
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          289
      title
      >=50-<65 Years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          166
      title
      >=65-<75 Years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          59
      title
      >=75 Years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          167
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          394
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          209
        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
          114
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          28
        7. group Id
          BG006
          value
          370
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
      title
      Black Or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        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
          2
      title
      Missing
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          20
      title
      Not Reported
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          8
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          197
      title
      White
    7. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
      title
      American Indian or Alaska Native
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      201
    2. group Id
      BG001
      value
      31
    3. group Id
      BG002
      value
      271
    4. group Id
      BG003
      value
      60
    5. group Id
      BG004
      value
      12
    6. group Id
      BG005
      value
      28
    7. group Id
      BG006
      value
      603
    units
    Participants
groups
  1. description
    Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
    id
    BG000
    title
    AZD9291 80mg Extension
  2. description
    Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
    id
    BG001
    title
    Dose Escalation
  3. description
    Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
    id
    BG002
    title
    Dose Expansion
  4. description
    Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
    id
    BG003
    title
    First Line
  5. description
    US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
    id
    BG004
    title
    80mg Tablet
  6. description
    Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
    id
    BG005
    title
    Japan Cytology
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          89
      title
      <50 Years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          142
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          289
      title
      >=50-<65 Years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          166
      title
      >=65-<75 Years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          59
      title
      >=75 Years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          167
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          394
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          209
        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
          114
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          28
        7. group Id
          BG006
          value
          370
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
      title
      Black Or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        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
          2
      title
      Missing
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          20
      title
      Not Reported
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          8
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          197
      title
      White
    7. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
      title
      American Indian or Alaska Native
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice