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NCT01736917 · BASELINE

Baseline characteristics

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors · Source last updated 2016-05-25

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
      64
    units
    Participants
groups
  1. description
    Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. \- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m\^2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
    id
    BG000
    title
    Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          15
          upper Limit
          66
          value
          33
    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
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          64
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          64
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      ECOG PS 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      ECOG PS 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      ECOG PS 2
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Cancer Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Cancer Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Cancer Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cancer Stage IS
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cancer Stage Unknown
    description
    Stage 0 Abnormal cells are present but have not spread to nearby tissue. Also called carcinoma in situ, or CIS. CIS is not cancer, but it may become cancer. Stage I, Stage II, and Stage III Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV The cancer has spread to distant parts of the body.
    param Type
    NUMBER
    title
    Cancer Stage
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Participants with Prior Chemotherapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      Participants without Prior Chemotherapy
    param Type
    NUMBER
    title
    Prior Chemotherapy
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
      title
      Bleomycin, etoposide, cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Etoposide, cisplatin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Vinblastine, ifosfamide, cisplatin
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cisplatin, Epirubicin
    param Type
    NUMBER
    title
    Chemotherapy Regimen
    unit Of Measure
    participants
population Description
64 participants were consented and treated per protocol. 1 participant listed in participant flow experienced an adverse event during infusion and was immediately taken off study. His baseline characteristics are not included in this table.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      64
    units
    Participants
groups
  1. description
    Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. \- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m\^2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
    id
    BG000
    title
    Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          15
          upper Limit
          66
          value
          33
    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
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          64
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          64
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      ECOG PS 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      ECOG PS 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      ECOG PS 2
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Cancer Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Cancer Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Cancer Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cancer Stage IS
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cancer Stage Unknown
    description
    Stage 0 Abnormal cells are present but have not spread to nearby tissue. Also called carcinoma in situ, or CIS. CIS is not cancer, but it may become cancer. Stage I, Stage II, and Stage III Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV The cancer has spread to distant parts of the body.
    param Type
    NUMBER
    title
    Cancer Stage
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Participants with Prior Chemotherapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      Participants without Prior Chemotherapy
    param Type
    NUMBER
    title
    Prior Chemotherapy
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
      title
      Bleomycin, etoposide, cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Etoposide, cisplatin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Vinblastine, ifosfamide, cisplatin
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cisplatin, Epirubicin
    param Type
    NUMBER
    title
    Chemotherapy Regimen
    unit Of Measure
    participants
population Description
64 participants were consented and treated per protocol. 1 participant listed in participant flow experienced an adverse event during infusion and was immediately taken off study. His baseline characteristics are not included in this table.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice