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NCT01987596 · ADVERSE EVENTS

Adverse events

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer · Source last updated 2020-10-29

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
6 months
Other-event reporting threshold
0%

Nothing to mention

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Fixed Filgrastim)

Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir. filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)

0 / 214 / 210 / 21
Arm II (Flexible Filgrastim)

Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir. filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)

0 / 211 / 210 / 21

Group identifiers: EG000: Arm I (Fixed Filgrastim) · EG001: Arm II (Flexible Filgrastim)

Serious adverse events

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

    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
      NON_SYSTEMATIC_ASSESSMENT
      notes
      GCSF related pain (headaches, back or extremities pain)
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        21
        num Events
        6
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        21
        num Events
        2
      term
      Pain
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      GCSF related pain including headaches, back and extremities pain
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        21
        num Events
        6
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        21
        num Events
        2
      term
      Pain
    Complete source fields
    description
    Nothing to mention
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      21
      description
      Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir. filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      21
      serious Num Affected
      0
      serious Num At Risk
      21
      title
      Arm I (Fixed Filgrastim)
    2. deaths Num Affected
      0
      deaths Num At Risk
      21
      description
      Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir. filgrastim: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
      id
      EG001
      other Num Affected
      1
      other Num At Risk
      21
      serious Num Affected
      0
      serious Num At Risk
      21
      title
      Arm II (Flexible Filgrastim)
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      GCSF related pain (headaches, back or extremities pain)
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        21
        num Events
        6
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        21
        num Events
        2
      term
      Pain
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      GCSF related pain including headaches, back and extremities pain
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        21
        num Events
        6
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        21
        num Events
        2
      term
      Pain
    time Frame
    6 months

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

    Preserved source evidence · Not medical advice