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NCT00047320 · ADVERSE EVENTS

Adverse events

Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors · Source last updated 2018-02-14

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
5%

104 patients enrolled, 2 are ineligible and not included in adverse event reporting. Therefore, adverse events participants reported is 102.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Radiation Therapy (CR From Induction)

Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV radiation therapy: craniospinal irradiation

8 / 10270 / 102Not reported / Not reported

Group identifiers: EG000: Radiation Therapy (CR From Induction)

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Febrile neutropenia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Nausea
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      2
    term
    Lymphocyte count decreased
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      102
      num Events
      5
    term
    Neutrophil count decreased
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Platelet count decreased
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      2
    term
    White blood cell decreased
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Hyperkalemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      3
    term
    Hypernatremia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      3
    term
    Hypokalemia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Hypophosphatemia
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Headache
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Seizure

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      102
      num Events
      108
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      9
    term
    Febrile neutropenia
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      16
    term
    Nausea
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
      num Events
      28
    term
    Vomiting
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      10
    term
    Infections and infestations - Other, specify
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      102
      num Events
      39
    term
    Alanine aminotransferase increased
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
      num Events
      22
    term
    Aspartate aminotransferase increased
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      102
      num Events
      42
    term
    Lymphocyte count decreased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      102
      num Events
      104
    term
    Neutrophil count decreased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      102
      num Events
      96
    term
    Platelet count decreased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      102
      num Events
      114
    term
    White blood cell decreased
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      102
      num Events
      37
    term
    Hyperglycemia
Complete source fields
description
104 patients enrolled, 2 are ineligible and not included in adverse event reporting. Therefore, adverse events participants reported is 102.
event Groups
  1. description
    Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV radiation therapy: craniospinal irradiation
    id
    EG000
    other Num Affected
    70
    other Num At Risk
    102
    serious Num Affected
    8
    serious Num At Risk
    102
    title
    Radiation Therapy (CR From Induction)
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      102
      num Events
      108
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      9
    term
    Febrile neutropenia
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      16
    term
    Nausea
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
      num Events
      28
    term
    Vomiting
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      102
      num Events
      10
    term
    Infections and infestations - Other, specify
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      102
      num Events
      39
    term
    Alanine aminotransferase increased
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      102
      num Events
      22
    term
    Aspartate aminotransferase increased
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      102
      num Events
      42
    term
    Lymphocyte count decreased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      102
      num Events
      104
    term
    Neutrophil count decreased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      102
      num Events
      96
    term
    Platelet count decreased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      102
      num Events
      114
    term
    White blood cell decreased
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      102
      num Events
      37
    term
    Hyperglycemia
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Febrile neutropenia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Nausea
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      2
    term
    Lymphocyte count decreased
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      102
      num Events
      5
    term
    Neutrophil count decreased
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Platelet count decreased
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      2
    term
    White blood cell decreased
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Hyperkalemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      3
    term
    Hypernatremia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      102
      num Events
      3
    term
    Hypokalemia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Hypophosphatemia
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Headache
  12. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      102
      num Events
      1
    term
    Seizure

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Preserved source evidence · Not medical advice