Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00002931 · OUTCOME

Toxic Effects

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer · Source last updated 2017-02-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From date of randomization until death of any cause, assessed up to 12 weeks

What was measured

Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy

Groups in this outcome

HD Chemo and Auto Stem Cells

Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
HD Chemo and Auto Stem Cells48

Reported measurements

Hyperglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells4Not reportedNot reportedNot reportedNot reported
Transaminase alone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells6Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells10Not reportedNot reportedNot reportedNot reported
Nausea/vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells5Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells3Not reportedNot reportedNot reportedNot reported
Hyperbilirubinemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells3Not reportedNot reportedNot reportedNot reported
Fever w/o neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells2Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells2Not reportedNot reportedNot reportedNot reported
Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells1Not reportedNot reportedNot reportedNot reported
Elevated INR/Prothrombin time
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells2Not reportedNot reportedNot reportedNot reported
Renal Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells1Not reportedNot reportedNot reportedNot reported
Constipation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells1Not reportedNot reportedNot reportedNot reported
Esophagitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo and Auto Stem Cells1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hyperglycemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Transaminase alone
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Mucositis/stomatitis
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Nausea/vomiting
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile neutropenia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Diarrhea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hyperbilirubinemia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Fever w/o neutropenia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hypocalcemia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemorrhage
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Elevated INR/Prothrombin time
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Renal Failure
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy
groups
  1. description
    Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
    id
    OG000
    title
    HD Chemo and Auto Stem Cells
param Type
NUMBER
reporting Status
POSTED
time Frame
From date of randomization until death of any cause, assessed up to 12 weeks
title
Toxic Effects
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice