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NCT01736917 · FLOW

Participant flow

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.

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
    FG000
    title
    Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        65
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        54
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
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
    FG000
    title
    Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        65
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        54
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice