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NCT01774344 · BASELINE

Baseline characteristics

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma · Source last updated 2020-08-20

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
      194
    2. group Id
      BG001
      value
      379
    3. group Id
      BG002
      value
      573
    units
    Participants
groups
  1. description
    Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care (BSC).
    id
    BG000
    title
    Placebo
  2. description
    Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
    id
    BG001
    title
    Regorafenib 160 mg (BAY73-4506)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          61.1
        2. group Id
          BG001
          spread
          12.4
          value
          61.8
        3. group Id
          BG002
          spread
          12.1
          value
          61.6
    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
          23
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          69
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          504
        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
          130
        2. group Id
          BG001
          value
          247
        3. group Id
          BG002
          value
          377
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          196
        title
        ECOG PS 1
    description
    ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 percent (%) waking hours (h), 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern cooperative oncology group (ECOG) Performance Status (PS) (data collection system-RAVE)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          380
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          193
        title
        ECOG PS 1
    description
    ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 % waking h, 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG PS: Interactive voice response system (IVRS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          217
        3. group Id
          BG002
          value
          324
        title
        less than (<) 400 nanogram per milliliter (ng/mL)
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          249
        title
        greater than or equal to (>=) 400 ng/mL
    description
    Alpha-Fetoprotein blood test was performed and baseline data were reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alpha-fetoprotein (AFP) (RAVE)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          317
        title
        < 400 ng/mL
      2. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          256
        title
        >= 400 ng/mL
    description
    AFP blood test was performed and baseline data were reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alpha-fetoprotein (AFP) (IVRS)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          409
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          164
        title
        Presence
    description
    Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Macrovascular invasion (RAVE)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          397
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          176
        title
        Presence
    description
    Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Macrovascular invasion (IVRS)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Early stage
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          75
        title
        Intermediate stage
      3. measurements
        1. group Id
          BG000
          value
          172
        2. group Id
          BG001
          value
          325
        3. group Id
          BG002
          value
          497
        title
        Advanced stage
    description
    BCLC classification divides HCC subjects in 5 stages (0=very early stage, A=early stage, B=intermediate stage, C=advanced stage and D=terminal stage) according to pre-established prognostic variables, and allocates therapies according to treatment-related status. Thus, it provides information on both prognostic prediction and treatment allocation.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    The Barcelona-Clinic Liver Cancer (BCLC) stage at study entry
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          161
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          265
        3. group Id
          BG002
          value
          412
        title
        Presence
    description
    Extrahepatic disease defined as presence or absence of tumor outside the liver.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extrahepatic disease (RAVE)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          191
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          250
        3. group Id
          BG002
          value
          382
        title
        Presence
    description
    Extrahepatic disease defined as presence or absence of tumor outside the liver.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extrahepatic disease (IVRS)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      194
    2. group Id
      BG001
      value
      379
    3. group Id
      BG002
      value
      573
    units
    Participants
groups
  1. description
    Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care (BSC).
    id
    BG000
    title
    Placebo
  2. description
    Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
    id
    BG001
    title
    Regorafenib 160 mg (BAY73-4506)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          61.1
        2. group Id
          BG001
          spread
          12.4
          value
          61.8
        3. group Id
          BG002
          spread
          12.1
          value
          61.6
    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
          23
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          69
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          504
        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
          130
        2. group Id
          BG001
          value
          247
        3. group Id
          BG002
          value
          377
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          196
        title
        ECOG PS 1
    description
    ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 percent (%) waking hours (h), 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern cooperative oncology group (ECOG) Performance Status (PS) (data collection system-RAVE)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          380
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          193
        title
        ECOG PS 1
    description
    ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 % waking h, 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG PS: Interactive voice response system (IVRS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          217
        3. group Id
          BG002
          value
          324
        title
        less than (<) 400 nanogram per milliliter (ng/mL)
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          249
        title
        greater than or equal to (>=) 400 ng/mL
    description
    Alpha-Fetoprotein blood test was performed and baseline data were reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alpha-fetoprotein (AFP) (RAVE)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          317
        title
        < 400 ng/mL
      2. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          256
        title
        >= 400 ng/mL
    description
    AFP blood test was performed and baseline data were reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alpha-fetoprotein (AFP) (IVRS)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          409
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          164
        title
        Presence
    description
    Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Macrovascular invasion (RAVE)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          397
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          176
        title
        Presence
    description
    Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Macrovascular invasion (IVRS)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Early stage
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          75
        title
        Intermediate stage
      3. measurements
        1. group Id
          BG000
          value
          172
        2. group Id
          BG001
          value
          325
        3. group Id
          BG002
          value
          497
        title
        Advanced stage
    description
    BCLC classification divides HCC subjects in 5 stages (0=very early stage, A=early stage, B=intermediate stage, C=advanced stage and D=terminal stage) according to pre-established prognostic variables, and allocates therapies according to treatment-related status. Thus, it provides information on both prognostic prediction and treatment allocation.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    The Barcelona-Clinic Liver Cancer (BCLC) stage at study entry
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          161
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          265
        3. group Id
          BG002
          value
          412
        title
        Presence
    description
    Extrahepatic disease defined as presence or absence of tumor outside the liver.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extrahepatic disease (RAVE)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          191
        title
        Absence
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          250
        3. group Id
          BG002
          value
          382
        title
        Presence
    description
    Extrahepatic disease defined as presence or absence of tumor outside the liver.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extrahepatic disease (IVRS)
    unit Of Measure
    Participants

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