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NCT02306161 · OUTCOME

Frequency of Toxicity-events

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma · Source last updated 2026-07-29

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

Measure
NUMBER
Unit
Reporting Periods
Interval / dispersion
Not reported
Time frame
Up to 202 days

What was measured

The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.

Analysis population: Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.

Groups in this outcome

Regimen A (VDC/IE)

INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV

Regimen B (VDC/IE + Ganitumab)

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV

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

Analysis denominator · Participants

GroupSource count
Regimen A (VDC/IE)145
Regimen B (VDC/IE + Ganitumab)150

Analysis denominator · Reporting Periods

GroupSource count
Regimen A (VDC/IE)527
Regimen B (VDC/IE + Ganitumab)576

Reported measurements

Source class 1
Values in Reporting Periods · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen A (VDC/IE)10Not reportedNot reportedNot reportedNot reported
Regimen B (VDC/IE + Ganitumab)27Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        27
denom Units Selected
Reporting Periods
denoms
  1. counts
    1. group Id
      OG000
      value
      145
    2. group Id
      OG001
      value
      150
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      527
    2. group Id
      OG001
      value
      576
    units
    Reporting Periods
description
The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.
groups
  1. description
    INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    id
    OG000
    title
    Regimen A (VDC/IE)
  2. description
    INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    id
    OG001
    title
    Regimen B (VDC/IE + Ganitumab)
param Type
NUMBER
population Description
Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.
reporting Status
POSTED
time Frame
Up to 202 days
title
Frequency of Toxicity-events
type
SECONDARY
type Units Analyzed
Reporting Periods
unit Of Measure
Reporting Periods

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice