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NCT01602666 · ADVERSE EVENTS

Adverse events

Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors · Source last updated 2025-11-20

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
From initiation of induction of therapy to the date of last follow-up, approximately 3 years. For most subjects the adverse events were observed while on active treatment or shortly thereafter.
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
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)

Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.

5 / 10784 / 10713 / 107
Stratum 2 Localized Germinoma

Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.

1 / 137107 / 1372 / 137

Group identifiers: EG000: Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) · EG001: Stratum 2 Localized Germinoma

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
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      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
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Headache
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Hydrocephalus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Intracranial hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Respiratory failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    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. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      137
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Acidosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      107
      num Events
      13
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      137
      num Events
      23
    term
    Alanine aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
      num Events
      3
    term
    Allergic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Anal mucositis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Anal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Anaphylaxis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      107
      num Events
      99
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      137
      num Events
      101
    term
    Anemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      137
      num Events
      2
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Appendicitis
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
    13
    deaths Num At Risk
    107
    description
    Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
    id
    EG000
    other Num Affected
    84
    other Num At Risk
    107
    serious Num Affected
    5
    serious Num At Risk
    107
    title
    Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
  2. deaths Num Affected
    2
    deaths Num At Risk
    137
    description
    Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
    id
    EG001
    other Num Affected
    107
    other Num At Risk
    137
    serious Num Affected
    1
    serious Num At Risk
    137
    title
    Stratum 2 Localized Germinoma
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      137
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Acidosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      107
      num Events
      13
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      137
      num Events
      23
    term
    Alanine aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
      num Events
      3
    term
    Allergic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Anal mucositis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Anal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Anaphylaxis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      107
      num Events
      99
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      137
      num Events
      101
    term
    Anemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      137
      num Events
      2
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Appendicitis
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
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      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
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Headache
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Hydrocephalus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Intracranial hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Respiratory failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
      num Events
      0
    term
    Sepsis
time Frame
From initiation of induction of therapy to the date of last follow-up, approximately 3 years. For most subjects the adverse events were observed while on active treatment or shortly thereafter.

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