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Trial · NCT00910429

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Treatment-emergent Adverse Events (TEAE)From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 yearsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With DeathFrom baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and CoagulationFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visit, and for each parameter.PercentageNUMBER
SECONDARYPercentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and CoagulationFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visit, and for each parameter.PercentageNUMBER
SECONDARYChange From Baseline of Hemoglobin in Hematology and CoagulationFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitgram/deciliter (g/dL)MEAN
SECONDARYPercentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical ChemistryFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visit, and for each parameter.PercentageNUMBER
SECONDARYPercentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical ChemistryFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visit, and for each parameter.PercentageNUMBER
SECONDARYChange From Baseline of Urate in Clinical ChemistryFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitmilligram/deciliter (mg/dL)MEAN
OTHER_PRE_SPECIFIEDChange of Systolic Blood Pressure (SBP)From baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitmillimetre(s) of mercury (mmHg)MEAN
OTHER_PRE_SPECIFIEDChange of Diastolic Blood Pressure (DBP)From baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitmmHgMEAN
OTHER_PRE_SPECIFIEDChange of Heart RateFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitbeats/minute (BPM)MEAN
OTHER_PRE_SPECIFIEDChange of WeightFrom baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitkilogram (kg)MEAN
OTHER_PRE_SPECIFIEDChange of Oxygen Saturation (SaO2)From baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitPercentageMEAN
OTHER_PRE_SPECIFIEDChange of Arterial Partial Oxygen Pressure (PaO2)From baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitmmHgMEAN
OTHER_PRE_SPECIFIEDChange of Arterial Partial Pressure of Carbon Dioxide (PaCO2)From baseline to Termination visit, up to 10 yearsParticipants in SAF with evaluable data for each visitmmHgMEAN
OTHER_PRE_SPECIFIEDChange of RR Duration From Electrocardiogram (ECG)From baseline to Month 48Participants in SAF with evaluable data for each visitmillisecond (msec)MEAN
OTHER_PRE_SPECIFIEDChange of PR Duration From ECGFrom baseline to Month 48Participants in SAF with evaluable data for each visitmsecMEAN
OTHER_PRE_SPECIFIEDChange of QRS Duration From ECGFrom baseline to Month 48Participants in SAF with evaluable data for each visitmsecMEAN
OTHER_PRE_SPECIFIEDChange of QT Duration in ECGFrom baseline to Month 48Participants in SAF with evaluable data for each visitmsecMEAN
OTHER_PRE_SPECIFIEDChange in Six-minute Walking Distance (6MWD) TestFrom baseline to End of study visit, up to 10 yearsParticipants in SAF with evaluable data for each visitmetersMEDIAN

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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