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Trial · NCT03280030

Results by group103

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

OutcomeGroupCategoryValueSpreadUnits
Percentage of Safety Events (Part 1, Japan Only)Midostaurin: Part 1 (Japan Only)Experienced at least 1 adverse event (AE)5Participants
Percentage of Safety Events (Part 1, Japan Only)Midostaurin: Part 1 (Japan Only)Safety events determined by ISC related to midostaurin (n = 3, 0, 0)0Participants
Event Free Survival (EFS) (Part 2 - Randomized, Controlled)Midostaurin: Part 27.695% Confidence Interval 3.6 to NAMonths
Event Free Survival (EFS) (Part 2 - Randomized, Controlled)Placebo: Part 2NA95% Confidence Interval 8.2 to NAMonths
Overall SurvivalMidostaurin: Part 2NA95% Confidence Interval 16.8 to NAMonths
Overall SurvivalPlacebo: Part 2NA95% Confidence Interval 18.8 to NAMonths
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2Overall CR70.095% Confidence Interval 50.60 to 85.27Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2Overall CR78.195% Confidence Interval 60.03 to 90.72Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2Morphologic CR with incomplete platelet count recovery (CRp)6.795% Confidence Interval 0.86 to 22.07Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2Morphologic CR with incomplete platelet count recovery (CRp)0.095% Confidence Interval 0.00 to 10.89Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2End of Induction cycle 1 (C1) CR56.795% Confidence Interval 37.43 to 74.54Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2End of Induction cycle 1 (C1) CR65.695% Confidence Interval 46.81 to 81.43Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2End of Induction C1: Morphologic CRp3.395% Confidence Interval 0.08 to 17.22Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2End of Induction C1: Morphologic CRp0.095% Confidence Interval 0.00 to 10.89Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2End of Induction cycle 2 (C2) CR13.395% Confidence Interval 3.76 to 30.72Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2End of Induction cycle 2 (C2) CR9.495% Confidence Interval 1.98 to 25.02Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2End of Induction C2: Morphologic CRp3.395% Confidence Interval 0.08 to 17.00Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2End of Induction C2: Morphologic CRp0.095% Confidence Interval 0.00 to 10.89Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2End of Consolidation CR36.795% Confidence Interval 19.93 to 56.14Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2End of Consolidation CR43.895% Confidence Interval 26.36 to 62.34Percentage 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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