Trial · NCT04173494
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Symptom Score (TSS) Response Rate at Week 24 | Baseline and Week 24 | Measured in the Intent-To-Treat (ITT) Analysis Set, which included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Transfusion Independence (TI) at Week 24 | Week 24 | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Splenic Response Rate (SRR) of >=25% at Week 24 | Baseline and Week 24 | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in MFSAF TSS at Week 24 | Baseline and Week 24 | ITT Analysis Set. Only those participants with data available at specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Splenic Response Rate (SRR) of >= 35% at Week 24 | Baseline and Week 24 | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks | Up to 24 weeks | ITT Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks | Up to 24 weeks | ITT Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Duration of MFSAF TSS Response | Up to a maximum of 151 weeks | ITT Analysis Set. Only those participants with data available at specified time point were analyzed. | Days | MEDIAN |
| SECONDARY | Duration of TI Response | Up to a maximum of 151 weeks | ITT Analysis Set. Only those participants with data available at specified time point were analyzed. | Days | MEDIAN |
| SECONDARY | Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks | Up to Week 24 | ITT Analysis Set. | Whole blood units | MEAN |
| SECONDARY | Percentage of Participants With Transfusion Dependence (TD) Status at Week 24 | Week 24 | ITT Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Hemoglobin Response | Baseline and Week 24 | ITT Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Number of Baseline TD Participants With TI Status at Week 24 | Week 24 | ITT Analysis Set. Only those participants with data available at specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of TI in Baseline TD Participants | Up to a maximum of 151 weeks | ITT Analysis Set. Only those participants with data available at specified time points were analyzed. | Days | MEDIAN |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24 | Up to Week 24 | Safety analysis set included all participants in the ITT Analysis set who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks | From Week 24 to a maximum of 151 weeks | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Up to a maximum of 151 weeks | ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis. | Days | MEDIAN |
| SECONDARY | Leukemia-free Survival (LFS) | Up to a maximum of 151 weeks | ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24 | Baseline and Week 24 | ITT Analysis Set. Only those participants with data available at specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Cancer-related Fatigue as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at Week 24 | Baseline and Week 24 | ITT Analysis Set. Only those participants with data available at specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04173494/outcomes