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NCT01767194 · ADVERSE EVENTS

Adverse events

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma · Source last updated 2022-10-24

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
Through completion of protocol therapy, up to approximately 1 year.
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 and patients that reported not receiving treatment are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)

CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV

5 / 1810 / 1812 / 18
Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)

Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO

18 / 5139 / 5115 / 51

Group identifiers: EG000: Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) · EG001: Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)

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
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    Allergic reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Anaphylaxis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BACTEREMIA - LINE INFECTIONS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    BLOOD
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Bronchospasm
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Creatinine increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Death NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Dehydration

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
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Activated partial thromboplastin time prolonged
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      51
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BACTEREMIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    BLOOD
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BLOOD - STAPHYLOCOCCUS EPIDERMIDIS ISOLATED.
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BLOOD - STAPHYLOCOCCUS HOMINIS ISOLATES
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 and patients that reported not receiving treatment are excluded from reporting of adverse events.
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    18
    description
    CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    18
    serious Num Affected
    5
    serious Num At Risk
    18
    title
    Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)
  2. deaths Num Affected
    15
    deaths Num At Risk
    51
    description
    Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    51
    serious Num Affected
    18
    serious Num At Risk
    51
    title
    Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Activated partial thromboplastin time prolonged
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      51
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BACTEREMIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    BLOOD
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BLOOD - STAPHYLOCOCCUS EPIDERMIDIS ISOLATED.
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BLOOD - STAPHYLOCOCCUS HOMINIS ISOLATES
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    Allergic reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Anaphylaxis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    BACTEREMIA - LINE INFECTIONS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
    term
    BLOOD
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Bronchospasm
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Creatinine increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Death NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE version 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
    term
    Dehydration
time Frame
Through completion of protocol therapy, up to approximately 1 year.

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Preserved source evidence · Not medical advice