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NCT00002850 · BASELINE

Baseline characteristics

Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy · Source last updated 2015-11-11

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
      69
    2. group Id
      BG001
      value
      76
    3. group Id
      BG002
      value
      67
    4. group Id
      BG003
      value
      212
    units
    Participants
groups
  1. description
    ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
    id
    BG000
    title
    Ciprofloxacin or Ofloxacin
  2. description
    trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..
    id
    BG001
    title
    TMP-SMX
  3. description
    No prophylaxis: The patient will receive no prophylactic antibiotics.
    id
    BG002
    title
    Observation
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32.4
          upper Limit
          86.0
          value
          63.7
        2. group Id
          BG001
          lower Limit
          36.7
          upper Limit
          85.7
          value
          62.6
        3. group Id
          BG002
          lower Limit
          36.7
          upper Limit
          89.3
          value
          65.0
        4. group Id
          BG003
          lower Limit
          32.4
          upper Limit
          89.3
          value
          63.2
    dispersion Type
    FULL_RANGE
    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
          32
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          79
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          133
        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
          54
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          160
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          52
      title
      Unknown
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          212
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          28
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          184
      title
      Unknown
    param Type
    NUMBER
    title
    Infection in last 6 months
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          34
      title
      Melphalan, Prednisone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          22
      title
      VBMCP
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          63
      title
      Vincristine, Adriamycin, Dexamethasone
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          93
      title
      Other
    description
    VBMCP=vincristine, carmustine, melphalan, cyclophosphamide, and prednisone
    param Type
    NUMBER
    title
    Chemotherapy regimen
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          3
          value
          1.0
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          4
          value
          1.1
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          4
          value
          0.8
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          4
          value
          1.0
    description
    ECOG PERFORMANCE STATUS: Used by doctors and researchers to assess how a patient's disease is progressing. 0: Fully active, able to carry on pre-disease performance 1. Restricted in physically strenuous activity but ambulatory; able to carry out work of a light or sedentary nature 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of limited selfcare, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on selfcare. Confined to bed or chair 5. Dead
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    units on a scale
population Description
Patients with symptomatic and untreated MM receiving chemotherapy without an active infection during the 7 days prior to initiation of chemotherapy and off antibiotics for the prior 7 days were eligable for this study. They were required to receive myelosuppressive and/or immunosuppressive chemotherapy, and were randomized on a 1:1 basis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      69
    2. group Id
      BG001
      value
      76
    3. group Id
      BG002
      value
      67
    4. group Id
      BG003
      value
      212
    units
    Participants
groups
  1. description
    ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
    id
    BG000
    title
    Ciprofloxacin or Ofloxacin
  2. description
    trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..
    id
    BG001
    title
    TMP-SMX
  3. description
    No prophylaxis: The patient will receive no prophylactic antibiotics.
    id
    BG002
    title
    Observation
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32.4
          upper Limit
          86.0
          value
          63.7
        2. group Id
          BG001
          lower Limit
          36.7
          upper Limit
          85.7
          value
          62.6
        3. group Id
          BG002
          lower Limit
          36.7
          upper Limit
          89.3
          value
          65.0
        4. group Id
          BG003
          lower Limit
          32.4
          upper Limit
          89.3
          value
          63.2
    dispersion Type
    FULL_RANGE
    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
          32
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          79
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          133
        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
          54
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          160
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          52
      title
      Unknown
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          212
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          28
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          184
      title
      Unknown
    param Type
    NUMBER
    title
    Infection in last 6 months
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          34
      title
      Melphalan, Prednisone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          22
      title
      VBMCP
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          63
      title
      Vincristine, Adriamycin, Dexamethasone
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          93
      title
      Other
    description
    VBMCP=vincristine, carmustine, melphalan, cyclophosphamide, and prednisone
    param Type
    NUMBER
    title
    Chemotherapy regimen
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          3
          value
          1.0
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          4
          value
          1.1
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          4
          value
          0.8
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          4
          value
          1.0
    description
    ECOG PERFORMANCE STATUS: Used by doctors and researchers to assess how a patient's disease is progressing. 0: Fully active, able to carry on pre-disease performance 1. Restricted in physically strenuous activity but ambulatory; able to carry out work of a light or sedentary nature 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of limited selfcare, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on selfcare. Confined to bed or chair 5. Dead
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    units on a scale
population Description
Patients with symptomatic and untreated MM receiving chemotherapy without an active infection during the 7 days prior to initiation of chemotherapy and off antibiotics for the prior 7 days were eligable for this study. They were required to receive myelosuppressive and/or immunosuppressive chemotherapy, and were randomized on a 1:1 basis.

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Preserved source evidence · Not medical advice