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Trial · NCT01772472

Outcomes29

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYInvasive Disease-free Survival (IDFS) Rate at 3 YearsAt Year 3ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
OTHER_PRE_SPECIFIEDIDFS Rate at 7 YearsAt Year 7ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
OTHER_PRE_SPECIFIEDIDFS Rate at 8 YearsAt Year 8ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYIDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 YearsAt Year 3ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYIDFS Including SPNBC Rate at 7 YearsAt Year 7ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYIDFS Including SPNBC Rate at 8 YearsAt Year 8ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYDisease-free Survival (DFS) Rate at 3 YearsAt Year 3ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYDFS Rate at 7 YearsAt Year 7ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYDFS Rate at 8 YearsAt Year 8ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYOverall Survival (OS) Rate at 5 YearsAt Year 5ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYOS Rate at 7 YearsAt Year 7ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYOS Rate at 8 YearsAt Year 8ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYDistant Recurrence-free Interval (DRFI) Rate at 3 YearsAt Year 3ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYDRFI Rate at 7 YearsAt Year 7ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYDRFI Rate at 8 YearsAt Year 8ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From signing of informed consent till end of follow up (up to approximately 131 months)SE population included all randomized participants who received any amount of study treatment.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review CommitteeUp to approximately 126 monthsSE population included all randomized participants who received any amount of study treatment.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Hepatotoxicity Events as Adjudicated by the Hepatic Review CommitteeUp to approximately 64 monthsSE population included all randomized participants who received any amount of study treatment.percentage of participantsNUMBER
SECONDARYNumber of Participants Who Discontinued Treatment Due to AEsUp to approximately 9.6 monthsSE population included all randomized participants who received any amount of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With AEs and SAEs Leading to DeathFrom signing of informed consent till end of follow up (up to approximately 131 months)SE population included all randomized participants who received any amount of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS

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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