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NCT00410124 · BASELINE

Baseline characteristics

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib · Source last updated 2013-01-15

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
      277
    2. group Id
      BG001
      value
      139
    3. group Id
      BG002
      value
      416
    units
    Participants
groups
  1. description
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    BG000
    title
    RAD001 +BSC
  2. description
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    BG001
    title
    Placebo + BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          263
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          153
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          322
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      277
    2. group Id
      BG001
      value
      139
    3. group Id
      BG002
      value
      416
    units
    Participants
groups
  1. description
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    BG000
    title
    RAD001 +BSC
  2. description
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    BG001
    title
    Placebo + BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          263
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          153
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          322
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice