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NCT01611662 · BASELINE

Baseline characteristics

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer · Source last updated 2019-07-29

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
      31
    units
    Participants
groups
  1. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies
    id
    BG000
    title
    Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          51
          upper Limit
          82
          value
          69
    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
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        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
          11
        title
        T2N0M0
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        T3N0M0
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        T4aN0Mo/TxN1M0
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline clinical stage
    unit Of Measure
    Participants
population Description
The tumor in patients was graded by TNM staging where T refers to the stage of primary tumor, n refers to the regional lymph nodes, M refers to distant metastasis. T0 - no evidence of primary tumor; N0- no regional lymph nodes; M0-no distant metastasis
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    units
    Participants
groups
  1. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies
    id
    BG000
    title
    Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          51
          upper Limit
          82
          value
          69
    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
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        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
          11
        title
        T2N0M0
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        T3N0M0
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        T4aN0Mo/TxN1M0
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline clinical stage
    unit Of Measure
    Participants
population Description
The tumor in patients was graded by TNM staging where T refers to the stage of primary tumor, n refers to the regional lymph nodes, M refers to distant metastasis. T0 - no evidence of primary tumor; N0- no regional lymph nodes; M0-no distant metastasis

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Preserved source evidence · Not medical advice