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NCT01231906 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma · Source last updated 2026-01-23

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
Up to 6 months post-treatment planned as 252 days; All-Cause Mortality: up to 9 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 are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Combination Chemotherapy)

INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.

8 / 308105 / 30851 / 308
Arm B (Combination Chemotherapy, Topotecan Hydrochloride)

INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.

11 / 31891 / 31842 / 318

Group identifiers: EG000: Arm A (Combination Chemotherapy) · EG001: Arm B (Combination Chemotherapy, Topotecan Hydrochloride)

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
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Heart failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Right ventricular dysfunction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      2
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Stomach pain

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
      16
      num At Risk
      308
      num Events
      16
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      318
      num Events
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      308
      num Events
      28
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      318
      num Events
      25
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Left ventricular systolic dysfunction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      308
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Anal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Cecal hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      308
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Diarrhea
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 are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    51
    deaths Num At Risk
    308
    description
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
    id
    EG000
    other Num Affected
    105
    other Num At Risk
    308
    serious Num Affected
    8
    serious Num At Risk
    308
    title
    Arm A (Combination Chemotherapy)
  2. deaths Num Affected
    42
    deaths Num At Risk
    318
    description
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
    id
    EG001
    other Num Affected
    91
    other Num At Risk
    318
    serious Num Affected
    11
    serious Num At Risk
    318
    title
    Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      308
      num Events
      16
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      318
      num Events
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      308
      num Events
      28
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      318
      num Events
      25
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Left ventricular systolic dysfunction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      308
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Anal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Cecal hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      308
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Diarrhea
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
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Heart failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Right ventricular dysfunction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      2
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Stomach pain
time Frame
Up to 6 months post-treatment planned as 252 days; All-Cause Mortality: up to 9 years

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