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Trial · NCT00782067

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants With Overall Response Rate (ORR)Midostaurin (PKC412)59.695% Confidence Interval 48.6 to 69.8Percentage of participants
Median Time to Duration of Response (DoR)Midostaurin (PKC412)31.495% Confidence Interval 10.8 to NAMonths
Median Time to Response (TTR)Midostaurin (PKC412)0.3Full Range 0.1 to 3.7Months
Median Time to Progression-Free Survival (PFS)Midostaurin (PKC412)17.095% Confidence Interval 10.2 to 24.8Months
Median Time to Overall Survival (OS)Midostaurin (PKC412)Primary Efficacy Population (PEP) (n=89)26.895% Confidence Interval 17.6 to 34.4Months
Median Time to Overall Survival (OS)Midostaurin (PKC412)Full Analysis Set (FAS) (n=116)28.795% Confidence Interval 20.3 to 38.0Months
Long-term Safety and Tolerability of MidostaurinMidostaurin (PKC412)AEs by Primary System Organ Class (SOC) (n=116)100Percentage of participants
Long-term Safety and Tolerability of MidostaurinMidostaurin (PKC412)SAEs by Primary System Organ Class (SOC) (n=88)75.9Percentage of participants
Long-term Safety and Tolerability of MidostaurinMidostaurin (PKC412)Deaths by Primary System Organ Class (SOC) (n=25)21.6Percentage of participants
Histopathologic ResponseMidostaurin (PKC412)>50% decrease in mast cell (MC) (n=41)46.1Percentage of participants
Histopathologic ResponseMidostaurin (PKC412)>0-<=50% decrease in mast cell (MC) (n=19)21.3Percentage of participants
Histopathologic ResponseMidostaurin (PKC412)>50% decrease in serum tryptase (n=52)58.4Percentage of participants
Histopathologic ResponseMidostaurin (PKC412)>0-<=50% decrease in serum tryptase (n=25)28.1Percentage 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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