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Trial · NCT01335932

Registered outcomes67

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

ListOutcomeTime frameDescription
PrimarySerum IL-6 LevelBaseline and Day 14Change between baseline and 14 days post-randomization between placebo \& ganciclovir groups
SecondaryNumber of Participants With CMV Reactivation at 28 Days in Plasmaat 28 days post-randomizationNumber of participants in baseline negatives with CMV reactivation at any level at day 28
SecondaryBAL Levels of IL-6at 7 days post-randomizationLevels of IL-6 from BALs at 7 days post-randomization
SecondaryNumber of Participants With Organ System Failure at 14 Daysat 14 days post-randomizationNumber of participants experiencing organ system failure at 14 days
SecondaryNumber of Days Alive and Not in the ICUby 28 days post-randomizationNumber of ICU days alive and not in the ICU by day 28
SecondaryCMV Diseaseby 180 days post-randomizationNeed to be biopsy-proven
SecondaryGrade 3 AEs or Higherby 35 days post-randomizationNumber of patients with greater than one AE of grade 3 or more
SecondarySF-36 Health Surveyat 1 day post-randomization
Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
SecondaryIncidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasmaat 28 days post-randomizationNumber of participants with CMV reactivation \>1,000 IU per mL at day 28 in plasma
SecondaryIncidence of CMV Reactivation at Any Level at 28 Days in Throatat 28 days post-randomizationCMV reactivation in baseline negatives at any level at day 28 in throat
SecondaryIncidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throatat 28 days post-randomizationNumber of participants with CMV reactivation \>1,000 IU per mL at day 28 in throat
SecondaryCMV AUC in BloodDay 0 to 28 days post-randomizationCMV AUC in blood from day 0 to day 28
SecondaryCMV AUC in ThroatDay 0 to 28 days post-randomizationCMV AUC in Throat from day 0 to day 28
SecondaryCMV Peak Viral Load in Bloodat 28 days post-randomizationCMV Peak Viremia in blood at day 28
SecondaryBAL Levels of IL-8at 7 days post-randomizationLevels of IL-8 in BALs at day 7
SecondaryBAL Levels of TNFaat 7 days post-randomizationLevels of TNFa in BALs at day 7
SecondaryPlasma Levels of IL-6at 7 days post-randomizationPlasma levels of IL-6.
SecondaryPlasma Levels of IL-8at 7 days post-randomizationLevels of IL-8 in plasma at day 7
SecondaryPlasma Levels of TNF aat 7 days post-randomizationPlasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1.
SecondaryPlasma Levels of TNF aDay 0 to 28 days post-randomizationPlasma levels of TNF a from day 0 to day 28

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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