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NCT00084838 · ADVERSE EVENTS

Adverse events

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT · Source last updated 2015-12-24

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
Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
Other-event reporting threshold
0%

SAEs were grade 3+ unexpected, treatment-related events deemed notable by the study chair. Accessible adverse event data represents a count of events by toxicity type rather than worst-grade by toxicity type and therefore cannot be reported in the established framework (Affected/At Risk). See secondary outcomes for events by system organ class.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)

Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.

4 / 200 / 0Not reported / Not reported

Group identifiers: EG000: Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)

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
    notes
    Patient died of pneumococcal sepsis
    organ System
    Infections and infestations
    source Vocabulary
    CTCAEv2
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAEv2
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Radiation recall
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAEv2
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Transverse Myeolitis

Other reported adverse events

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

    Complete source fields
    description
    SAEs were grade 3+ unexpected, treatment-related events deemed notable by the study chair. Accessible adverse event data represents a count of events by toxicity type rather than worst-grade by toxicity type and therefore cannot be reported in the established framework (Affected/At Risk). See secondary outcomes for events by system organ class.
    event Groups
    1. description
      Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      4
      serious Num At Risk
      20
      title
      Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Patient died of pneumococcal sepsis
      organ System
      Infections and infestations
      source Vocabulary
      CTCAEv2
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Sepsis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEv2
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        20
        num Events
        2
      term
      Radiation recall
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEv2
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Transverse Myeolitis
    time Frame
    Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice