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NCT00354744 · ADVERSE EVENTS

Adverse events

High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma · Source last updated 2020-01-29

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
Not reported
Other-event reporting threshold
0%

The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.

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

Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.

4 / 10895 / 108Not reported / Not reported

Group identifiers: EG000: High_Risk_Rhabdomyosarcoma

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Anorectal infection
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Infections and infestations - Other
  3. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Radiation recall reaction (dermatologic)
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Sepsis

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Abdominal distension
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
    term
    Abdominal infection
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      108
    term
    Abdominal pain
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Acidosis
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Activated partial thromboplastin time prolonged
  6. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Acute kidney injury
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Adult respiratory distress syndrome
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      108
    term
    Alanine aminotransferase increased
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Alkalosis
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
    term
    Anal pain
  11. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
    term
    Anaphylaxis
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
    term
    Anemia
Complete source fields
description
The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
event Groups
  1. description
    Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
    id
    EG000
    other Num Affected
    95
    other Num At Risk
    108
    serious Num Affected
    4
    serious Num At Risk
    108
    title
    High_Risk_Rhabdomyosarcoma
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Abdominal distension
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
    term
    Abdominal infection
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      108
    term
    Abdominal pain
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Acidosis
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Activated partial thromboplastin time prolonged
  6. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Acute kidney injury
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Adult respiratory distress syndrome
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      108
    term
    Alanine aminotransferase increased
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Alkalosis
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
    term
    Anal pain
  11. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
    term
    Anaphylaxis
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
    term
    Anemia
serious Events
  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Anorectal infection
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Infections and infestations - Other
  3. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Radiation recall reaction (dermatologic)
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
    term
    Sepsis

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

Preserved source evidence · Not medical advice