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NCT00554788 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma · Source last updated 2025-01-13

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
Up to 30 days after completion of study treatment.
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). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stage 2/3 Patients

Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).

1 / 1813 / 182 / 18
Stage 4a Patients

Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.

2 / 1812 / 185 / 18
Stage 4b Patients

Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.

0 / 1910 / 1915 / 19

Group identifiers: EG000: Stage 2/3 Patients · EG001: Stage 4a Patients · EG002: Stage 4b Patients

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
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    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
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Apnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Catheter related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Cognitive disturbance
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      19
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Depressed level of consciousness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Diarrhea
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). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    18
    description
    Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    18
    serious Num Affected
    1
    serious Num At Risk
    18
    title
    Stage 2/3 Patients
  2. deaths Num Affected
    5
    deaths Num At Risk
    18
    description
    Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    18
    serious Num Affected
    2
    serious Num At Risk
    18
    title
    Stage 4a Patients
  3. deaths Num Affected
    15
    deaths Num At Risk
    19
    description
    Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    19
    serious Num Affected
    0
    serious Num At Risk
    19
    title
    Stage 4b Patients
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Apnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Catheter related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Cognitive disturbance
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      19
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
    term
    Depressed level of consciousness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
    term
    Sepsis
time Frame
Up to 30 days after completion of study treatment.

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Preserved source evidence · Not medical advice