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NCT00346164 · ADVERSE EVENTS

Adverse events

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma · Source last updated 2022-04-28

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
Not reported
Other-event reporting threshold
0%

Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: No Adjuvant Treatment

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only). clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery

0 / 2050 / 205Not reported / Not reported
Arm B: Low Risk; Adjuvant Radiotherapy

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy

1 / 170 / 17Not reported / Not reported
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy

High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV

1 / 1102 / 110Not reported / Not reported
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy

High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV

3 / 1967 / 196Not reported / Not reported

Group identifiers: EG000: Arm A: No Adjuvant Treatment · EG001: Arm B: Low Risk; Adjuvant Radiotherapy · EG002: Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy · EG003: Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy

Serious adverse events

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

  1. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Death NOS
  2. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Infections and infestations - Other, specify
  3. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
  4. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      196
      num Events
      0
    term
    Treatment related secondary malignancy
  5. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      196
      num Events
      0
    term
    Upper gastrointestinal hemorrhage

Other reported adverse events

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

  1. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Cardiac disorders - Other, specify
  2. organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Dermatitis radiation
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Diarrhea
  4. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Encephalopathy
  5. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    General disorders and administration site conditions - Other, specify
  6. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Hepatic infection
  7. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Hypokalemia
  8. organ System
    Vascular disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Hypotension
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Pericardial effusion
  10. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Seizure
  11. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Skin ulceration
  12. organ System
    Vascular disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Thromboembolic event
Complete source fields
description
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
event Groups
  1. description
    Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only). clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    205
    serious Num Affected
    0
    serious Num At Risk
    205
    title
    Arm A: No Adjuvant Treatment
  2. description
    Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    17
    serious Num Affected
    1
    serious Num At Risk
    17
    title
    Arm B: Low Risk; Adjuvant Radiotherapy
  3. description
    High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    110
    serious Num Affected
    1
    serious Num At Risk
    110
    title
    Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
  4. description
    High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    196
    serious Num Affected
    3
    serious Num At Risk
    196
    title
    Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
frequency Threshold
0
other Events
  1. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Cardiac disorders - Other, specify
  2. organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Dermatitis radiation
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Diarrhea
  4. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Encephalopathy
  5. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    General disorders and administration site conditions - Other, specify
  6. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Hepatic infection
  7. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Hypokalemia
  8. organ System
    Vascular disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Hypotension
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Pericardial effusion
  10. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Seizure
  11. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Skin ulceration
  12. organ System
    Vascular disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Thromboembolic event
serious Events
  1. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Death NOS
  2. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Infections and infestations - Other, specify
  3. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      196
      num Events
      1
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
  4. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      110
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      196
      num Events
      0
    term
    Treatment related secondary malignancy
  5. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      205
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      110
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      196
      num Events
      0
    term
    Upper gastrointestinal hemorrhage

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

Preserved source evidence · Not medical advice