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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 Participants With Complete Remission (CR)Midostaurin: Part 2End of Consolidation Morphologic CRp3.395% Confidence Interval 0.08 to 17.22Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2End of Consolidation Morphologic CRp9.495% Confidence Interval 1.98 to 25.02Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2After treatment discontinuation CR10.095% Confidence Interval 2.11 to 26.53Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2After treatment discontinuation CR3.195% Confidence Interval 0.08 to 16.22Percentage of participants
Percentage of Participants With Complete Remission (CR)Midostaurin: Part 2After treatment discontinuation Morphologic CRp0.095% Confidence Interval 0.00 to 11.57Percentage of participants
Percentage of Participants With Complete Remission (CR)Placebo: Part 2After treatment discontinuation Morphologic CRp6.395% Confidence Interval 0.77 to 20.81Percentage of participants
Percentage of Participants With Cumulative Incidence of Relapse (CIR)Midostaurin: Part 221Participants
Percentage of Participants With Cumulative Incidence of Relapse (CIR)Placebo: Part 225Participants
Pharmakinetics (PK) for Midostaurin: AUClast & AUC0-tMidostaurin: Part 2AUClast17900Geometric Coefficient of Variation 53.5ng*hr/mL
Pharmakinetics (PK) for Midostaurin: AUClast & AUC0-tMidostaurin: Part 2AUC0-t19200Geometric Coefficient of Variation 49.0ng*hr/mL
Pharmakinetics (PK) for Midostaurin: CmaxMidostaurin: Part 22420Geometric Coefficient of Variation 46.5ng/mL
Metabolite CGP52421: PK Parameters AUClast, AUC0-tMidostaurin: Part 2AUClast754Geometric Coefficient of Variation 116ng*hr/mL
Metabolite CGP52421: PK Parameters AUClast, AUC0-tMidostaurin: Part 2AUC0-t876Geometric Coefficient of Variation 92.3ng*hr/mL
Metabolite CGP52421: PK Parameter CmaxMidostaurin: Part 298.6Geometric Coefficient of Variation 83.5ng/mL
Metabolite CGP62221: PK Parameters: AUClast, AUC0-tMidostaurin: Part 2AUClast1430Geometric Coefficient of Variation 223ng*hr/mL
Metabolite CGP62221: PK Parameters: AUClast, AUC0-tMidostaurin: Part 2AUC0-t1730Geometric Coefficient of Variation 182ng*hr/mL
Metabolite CGP62221: PK Parameter: CmaxMidostaurin: Part 2196Geometric Coefficient of Variation 159ng/mL
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30Midostaurin: Part 2EOI: Global health status (GHS):GHS27.8Standard Deviation 31.03scores on a scale
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30Placebo: Part 2EOI: Global health status (GHS):GHS0.0Standard Deviation 16.67scores on a scale
Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30Midostaurin: Part 2EOCons: GHS:GHS20.8Standard Deviation 11.49scores on a scale

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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