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NCT00073307 · BASELINE

Baseline characteristics

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer · Source last updated 2014-02-06

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
      451
    2. group Id
      BG001
      value
      452
    3. group Id
      BG002
      value
      903
    units
    Participants
groups
  1. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    id
    BG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19.0
          upper Limit
          86.0
          value
          58.0
        2. group Id
          BG001
          lower Limit
          29.0
          upper Limit
          84.0
          value
          59.0
        3. group Id
          BG002
          lower Limit
          19.0
          upper Limit
          86.0
          value
          59.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          304
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          632
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          271
      title
      >= 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          112
        3. group Id
          BG002
          value
          248
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          315
        2. group Id
          BG001
          value
          340
        3. group Id
          BG002
          value
          655
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          453
      title
      Low
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          449
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    The Motzer score risk factors predicting survival in participants with metastatic RCC are as following: • Low ECOG performance status (PS\>2) • High lactate dehydrogenase (\>1.5 times upper limit of normal) • Low serum hemoglobin (\<lower limit of normal) • High corrected serum calcium (\>10 mg/dL) • Absence of prior nephrectomy factors.
    param Type
    NUMBER
    title
    Motzer Category (Low, intermediate or high)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          211
        3. group Id
          BG002
          value
          430
      title
      PS 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          223
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          458
      title
      PS 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      PS 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Missing
    description
    ECOG = Eastern cooperative oncology group PS levels are 0 (Fully active, able to carry on all pre-disease performance), 1 (ambulatory and able to carry out work of a light or sedentary), 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities), 3 (Capable of only limited selfcare, confined to bed or chair more than 50% of awake time), 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) and 5 (death).
    param Type
    NUMBER
    title
    ECOG Performance Status (PS)
    unit Of Measure
    Participants by scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          32
      title
      Stage III
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          433
        2. group Id
          BG001
          value
          438
        3. group Id
          BG002
          value
          871
      title
      Stage IV
    description
    TNM=Tumor, primary (T); Nodes, regional lymph nodes (N); Metastasis, distant (M). T0/N0/M0=no evidence of aspect. N1=metastasis in single regional lymph node, M1=distant metastasis. T1=tumor 7 cm or less in greatest dimension limited to kidney. T2= tumor \>7 cm in greatest dimension limited to kidney. T3=tumor extends into major veins, invades adrenal gland, or peripheric tissues but not beyond Gerota's fascia. T4=tumor invades beyond Gerota's fascia. \[Stage I: T1, N0, M0\]\[Stage II=T2, N0, M0\]\[Stage IV=T4, N0, M0; T4, N1, M0; any T, N2, M0; any T, any N, M1\]\[Stage III=remaining combinations\]
    param Type
    NUMBER
    title
    TNM Classification at study entry
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          449
        2. group Id
          BG001
          value
          447
        3. group Id
          BG002
          value
          896
      title
      Clear Cell
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Papillary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Granular
    description
    Histopathological characterization of renal cell carcinomas that subjects had included clear cell, papillary or granular carcinomas. Clear cell renal cell carcinoma is a renal cortical tumor typically characterized by malignant epithelial cells with clear cytoplasm and a compact-alveolar (nested) or acinar growth pattern interspersed with intricate, arborizing vasculature. Tumors in which eosinophilic cells predominate were classified as "granular cell" carcinoma. Papillary renal cell carcinoma is an uncommon subtype that has distinctive gross, histologic, and cytogenetic features.
    param Type
    NUMBER
    title
    Cancer Subtypes
    unit Of Measure
    Participants with carcinoma type
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      451
    2. group Id
      BG001
      value
      452
    3. group Id
      BG002
      value
      903
    units
    Participants
groups
  1. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    id
    BG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19.0
          upper Limit
          86.0
          value
          58.0
        2. group Id
          BG001
          lower Limit
          29.0
          upper Limit
          84.0
          value
          59.0
        3. group Id
          BG002
          lower Limit
          19.0
          upper Limit
          86.0
          value
          59.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          304
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          632
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          271
      title
      >= 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          112
        3. group Id
          BG002
          value
          248
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          315
        2. group Id
          BG001
          value
          340
        3. group Id
          BG002
          value
          655
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          453
      title
      Low
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          449
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    The Motzer score risk factors predicting survival in participants with metastatic RCC are as following: • Low ECOG performance status (PS\>2) • High lactate dehydrogenase (\>1.5 times upper limit of normal) • Low serum hemoglobin (\<lower limit of normal) • High corrected serum calcium (\>10 mg/dL) • Absence of prior nephrectomy factors.
    param Type
    NUMBER
    title
    Motzer Category (Low, intermediate or high)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          211
        3. group Id
          BG002
          value
          430
      title
      PS 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          223
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          458
      title
      PS 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      PS 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Missing
    description
    ECOG = Eastern cooperative oncology group PS levels are 0 (Fully active, able to carry on all pre-disease performance), 1 (ambulatory and able to carry out work of a light or sedentary), 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities), 3 (Capable of only limited selfcare, confined to bed or chair more than 50% of awake time), 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) and 5 (death).
    param Type
    NUMBER
    title
    ECOG Performance Status (PS)
    unit Of Measure
    Participants by scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          32
      title
      Stage III
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          433
        2. group Id
          BG001
          value
          438
        3. group Id
          BG002
          value
          871
      title
      Stage IV
    description
    TNM=Tumor, primary (T); Nodes, regional lymph nodes (N); Metastasis, distant (M). T0/N0/M0=no evidence of aspect. N1=metastasis in single regional lymph node, M1=distant metastasis. T1=tumor 7 cm or less in greatest dimension limited to kidney. T2= tumor \>7 cm in greatest dimension limited to kidney. T3=tumor extends into major veins, invades adrenal gland, or peripheric tissues but not beyond Gerota's fascia. T4=tumor invades beyond Gerota's fascia. \[Stage I: T1, N0, M0\]\[Stage II=T2, N0, M0\]\[Stage IV=T4, N0, M0; T4, N1, M0; any T, N2, M0; any T, any N, M1\]\[Stage III=remaining combinations\]
    param Type
    NUMBER
    title
    TNM Classification at study entry
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          449
        2. group Id
          BG001
          value
          447
        3. group Id
          BG002
          value
          896
      title
      Clear Cell
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Papillary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Granular
    description
    Histopathological characterization of renal cell carcinomas that subjects had included clear cell, papillary or granular carcinomas. Clear cell renal cell carcinoma is a renal cortical tumor typically characterized by malignant epithelial cells with clear cytoplasm and a compact-alveolar (nested) or acinar growth pattern interspersed with intricate, arborizing vasculature. Tumors in which eosinophilic cells predominate were classified as "granular cell" carcinoma. Papillary renal cell carcinoma is an uncommon subtype that has distinctive gross, histologic, and cytogenetic features.
    param Type
    NUMBER
    title
    Cancer Subtypes
    unit Of Measure
    Participants with carcinoma type

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Preserved source evidence · Not medical advice