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NCT00471497 · BASELINE

Baseline characteristics

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) · Source last updated 2020-11-18

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
      283
    2. group Id
      BG001
      value
      282
    3. group Id
      BG002
      value
      281
    4. group Id
      BG003
      value
      846
    units
    Participants
groups
  1. description
    Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
    id
    BG000
    title
    Imatinib 400 mg QD
  2. description
    Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    BG001
    title
    Nilotinb 300 mg BID
  3. description
    Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    BG002
    title
    Nilotinib 400 mg BID
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          195
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      <35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          176
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >= 35 - <45 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          200
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >=45 - <55 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          177
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >=55 - < 65 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          98
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          106
        4. group Id
          BG003
          value
          355
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          175
        4. group Id
          BG003
          value
          491
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          187
        2. group Id
          BG001
          value
          170
        3. group Id
          BG002
          value
          185
        4. group Id
          BG003
          value
          542
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          30
      denoms
      1. counts
        1. group Id
          BG000
          value
          282
        2. group Id
          BG001
          value
          281
        3. group Id
          BG002
          value
          280
        4. group Id
          BG003
          value
          843
        units
        Participants
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          213
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Asian
    4. 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
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          58
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Other
    param Type
    NUMBER
    population Description
    Missing patient that cannot be identified
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      283
    2. group Id
      BG001
      value
      282
    3. group Id
      BG002
      value
      281
    4. group Id
      BG003
      value
      846
    units
    Participants
groups
  1. description
    Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
    id
    BG000
    title
    Imatinib 400 mg QD
  2. description
    Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    BG001
    title
    Nilotinb 300 mg BID
  3. description
    Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    BG002
    title
    Nilotinib 400 mg BID
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          195
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      <35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          176
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >= 35 - <45 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          200
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >=45 - <55 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          177
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >=55 - < 65 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          98
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          106
        4. group Id
          BG003
          value
          355
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          175
        4. group Id
          BG003
          value
          491
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          187
        2. group Id
          BG001
          value
          170
        3. group Id
          BG002
          value
          185
        4. group Id
          BG003
          value
          542
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          30
      denoms
      1. counts
        1. group Id
          BG000
          value
          282
        2. group Id
          BG001
          value
          281
        3. group Id
          BG002
          value
          280
        4. group Id
          BG003
          value
          843
        units
        Participants
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          213
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Asian
    4. 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
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          58
      denoms
      1. counts
        1. group Id
          BG000
          value
          283
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          281
        4. group Id
          BG003
          value
          846
        units
        Participants
      title
      Other
    param Type
    NUMBER
    population Description
    Missing patient that cannot be identified
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice