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NCT02306161 · ADVERSE EVENTS

Adverse 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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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

3 / 145114 / 14561 / 145
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

45 / 150122 / 15067 / 150

Group identifiers: EG000: Regimen A (VDC/IE) · EG001: Regimen B (VDC/IE + Ganitumab)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      150
      num Events
      6
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Left ventricular systolic dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      150
      num Events
      3
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Colonic perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      150
      num Events
      2
    term
    Esophagitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Gastrointestinal disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      150
      num Events
      6
    term
    Mucositis oral

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      145
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      150
      num Events
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      145
      num Events
      38
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      150
      num Events
      50
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Papilledema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      150
      num Events
      3
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Anal fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Anal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Enterocolitis
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    61
    deaths Num At Risk
    145
    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
    EG000
    other Num Affected
    114
    other Num At Risk
    145
    serious Num Affected
    3
    serious Num At Risk
    145
    title
    Regimen A (VDC/IE)
  2. deaths Num Affected
    67
    deaths Num At Risk
    150
    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
    EG001
    other Num Affected
    122
    other Num At Risk
    150
    serious Num Affected
    45
    serious Num At Risk
    150
    title
    Regimen B (VDC/IE + Ganitumab)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      145
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      150
      num Events
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      145
      num Events
      38
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      150
      num Events
      50
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Papilledema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      150
      num Events
      3
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Anal fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Anal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Enterocolitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      150
      num Events
      6
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Left ventricular systolic dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      150
      num Events
      3
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      150
      num Events
      0
    term
    Colonic perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      150
      num Events
      2
    term
    Esophagitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Gastrointestinal disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      145
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
      num Events
      1
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      150
      num Events
      6
    term
    Mucositis oral
time Frame
Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years

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