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NCT00053352 · ADVERSE EVENTS

Adverse events

Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors · Source last updated 2021-07-13

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%

Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 2 (Observation)

Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm. Observation only for recurrence or development of an SMN

0 / 1040 / 104Not reported / Not reported
Arm I (Chemotherapy)

Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes \& etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 \& 6). After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy. After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy. Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, \& 16. con

0 / 18278 / 182Not reported / Not reported

Group identifiers: EG000: Arm 2 (Observation) · EG001: Arm I (Chemotherapy)

Serious adverse events

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

    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
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        182
      term
      Abdominal pain
    2. organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Acute kidney injury
    3. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Alanine aminotransferase increased
    4. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        182
      term
      Anemia
    5. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Aspartate aminotransferase increased
    6. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Catheter related infection
    7. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Constipation
    8. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Dehydration
    9. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Encephalopathy
    10. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        9
        num At Risk
        182
      term
      Febrile neutropenia
    11. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        182
      term
      Fever
    12. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Gastrointestinal disorders - Other, specify
    Complete source fields
    description
    Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
    event Groups
    1. description
      Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm. Observation only for recurrence or development of an SMN
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      104
      serious Num Affected
      0
      serious Num At Risk
      104
      title
      Arm 2 (Observation)
    2. description
      Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes \& etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 \& 6). After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy. After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy. Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, \& 16. con
      id
      EG001
      other Num Affected
      78
      other Num At Risk
      182
      serious Num Affected
      0
      serious Num At Risk
      182
      title
      Arm I (Chemotherapy)
    frequency Threshold
    0
    other Events
    1. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        182
      term
      Abdominal pain
    2. organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Acute kidney injury
    3. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Alanine aminotransferase increased
    4. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        182
      term
      Anemia
    5. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Aspartate aminotransferase increased
    6. organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Catheter related infection
    7. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Constipation
    8. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Dehydration
    9. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Encephalopathy
    10. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        9
        num At Risk
        182
      term
      Febrile neutropenia
    11. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        182
      term
      Fever
    12. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        104
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        182
      term
      Gastrointestinal disorders - Other, specify

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

    Preserved source evidence · Not medical advice