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Trial · NCT02124746

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLong Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory AbnormalitiesFrom the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.
It was pre-specified that safety outcomes would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore data for this outcome measure are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSplenic Response RateFrom baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.Subjects with splenomegaly \>5 cm at baseline in the parent studies who were enrolled in Study GS-US-352-1154 were evaluable for splenic response assessment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of Splenic ResponseFrom baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.Duration of splenic response was assessed for spleen responders who enrolled in Study GS-US-352-1154 only.daysMEDIAN
SECONDARYTransfusion Independence Response RateFrom baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.Subjects who were transfusion dependent at baseline in the parent studies and were enrolled in Study GS-US-352-1154 were evaluable for transfusion independence response.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of Transfusion Independence ResponseFrom baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.Duration of transfusion independence response was assessed for transfusion independence responders who were enrolled in Study GS-US-352-1154.daysMEDIAN
SECONDARYAnemia Response RateFrom baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.Subjects who were anemia response-evaluable at baseline in the parent studies and were enrolled in Study GS-US-352-1154 were evaluable for anemia response.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of Anemia ResponseFrom baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.Duration of anemia response was assessed for anemia responders who were enrolled in Study GS-US-352-1154.daysMEDIAN
SECONDARYRate of RBC TransfusionFrom the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154.
It was pre-specified that safety outcomes would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore data for this outcome measure are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
RBC units per monthMEDIAN
SECONDARYOverall SurvivalFrom baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib.monthsMEDIAN
SECONDARYProgression-Free SurvivalFrom baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib.monthsMEDIAN
SECONDARYLeukemia-Free SurvivalFrom baseline in the parent study until the date of the last assessment, up to 30 days following permanent discontinuation of momelotinib.monthsMEDIAN

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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