Trial · NCT03416179
Outcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 44
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intensive Study: Overall Survival (OS) | Baseline up to 25 months | FA set included all randomized participants. | months | MEDIAN |
| PRIMARY | Non-intensive Study: Overall Survival (OS) | Baseline up to 25 months | FA set included all randomized participants. | months | MEDIAN |
| SECONDARY | Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Post-baseline up to Week 8 | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Post-baseline up to Week 12 | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Partial Remission (PR) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Partial Remission (PR) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) | Day 1 up to maximum of 3 years | FA set included all randomized participants. This outcome measure was planned to be analyzed only in non-intensive study. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Duration of Response (DoRi) | From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years) | The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, DORi was not collected, analyzed and reported. | ||
| SECONDARY | Non-intensive Study: Duration of Response (DoRi) or (DoRh) | From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years) | The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, DORi and DoRh was not collected, analyzed and reported. | ||
| SECONDARY | Non-intensive Study: Time to Response | From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years) | FA set included all randomized participants. | Months | MEAN |
| SECONDARY | Intensive Study: Event-free Survival (EFS) | From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years) | The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EFS was not collected, analyzed and reported. | ||
| SECONDARY | Non-intensive Study: Event-free Survival (EFS) | From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years) | The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EFS was not collected, analyzed and reported. |
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
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GET https://conductscience.org/api/trials/v1/NCT03416179/outcomes