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Trial · NCT04099901

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryReduction of the incidence of fever during neutropeniaPrimary outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryReduction in incidence of mucositis-related feverOutcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryDaily mean CRP levelOutcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryIntestinal mucositis as measured by the area-under-the-curve of reciprocal citrulline levelsOutcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryClinical mucositis as determined by the daily mouth and gut scoresOutcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryDays with fever (≥ 38.5° C)Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryIncidence of bloodstream infections i.e. bacteremiaOutcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryLength of hospital stay in daysOutcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryUse of systemic antimicrobial agents (incidence and duration)Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryUse of analgesic drugs (incidence and duration)Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryUse of total parenteral nutrition (TPN) (incidence and duration)Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
SecondaryQuality of life according to the EORTC QLQ-C30Baseline, +30 days/discharge (whichever comes first), +100 days, +1 yearQuality of life according to the EORTC QLQ-C30
SecondaryFatigue severity according to the FACIT-Fatigue scaleBaseline, +30 days/discharge (whichever comes first), +100 days, +1 yearSeverity of fatigue as the score measured by the validated FACIT-Fatigue scale
SecondaryShort term overall survival+100 days and +1 year
SecondaryTumor response evaluation+100 days and +1 year

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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