Trial · NCT03182244
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of randomization up to the date of death (up to approximatley 74 months) | ITT | months | MEDIAN |
| SECONDARY | Event-Free Survival (EFS) | From the date of randomization up to the date of documented relapse, treatment failure or death from any cause, off-treatment relapse and start of new AML therapy (up to approximately 74 months) | ITT | months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Duration of CR | From date of achieving CR until date of confirmed relapse (maximum duration was 53.4 months ) | ITT. Participants with CR were analyzed. | months | MEDIAN |
| SECONDARY | Duration of Composite Complete Remission (CRc) | From date of achieving CRc until date of confirmed relapse (maximum duration was 60 months) | ITT. Participants with best overall response of CRc were analyzed. | months | MEDIAN |
| SECONDARY | Duration of CR/Complete Remission With Partial Hematologic Recovery (CRh) | From date of achieving CR/CRh until date of confirmed relapse (maximum duration was 58.1 months) | ITT. Participants with CR/CRh were analyzed. | months | MEDIAN |
| SECONDARY | Duration Of Response (DOR) | From date of achieving CRc/PR until date of confirmed relapse (maximum duration was 52.1 months) | ITT. Participants with best overall response of CRc/PR were analyzed. | months | MEDIAN |
| SECONDARY | CR/CRh Rate | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Best Response Rate | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Leukemia-Fee Survival (LFS) | From first day of achieving first CRc to the first day of confirmed relapse/death (maximum duration was 60.0 months) | ITT. Participants with best overall response of CRc were analyzed. | months | MEDIAN |
| SECONDARY | Composite Complete Remission (CRc) | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Time to CRc | From randomization until date of first CRc (up to approximately 74 months) | ITT population. Participants who achieved CRc were analyzed. | months | MEDIAN |
| SECONDARY | Time to CR | From randomization until date of first CR (up to approximately 74 months) | ITT population. Participants who achieved CR were analyzed. | months | MEDIAN |
| SECONDARY | Time to Response | From randomization until date of first CRc or PR (up to approximately 74 months) | ITT population. Participants who achieved CRc or PR were analyzed. | months | MEDIAN |
| SECONDARY | Time to CR/CRh | From randomization until date of first CR/CRh (up to approximately 74 months) | ITT population. Participants who achieved CR/CRh were analyzed. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Transfusion Conversion and Transfusion Maintenance | Baseline up to approximately 74 months | ITT population with available data at specified timepoint. This endpoint was planned to be analyzed only for Giltertinib arm. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Transplantation Rate | Baseline up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Brief Fatigue Inventory (BFI) | Baseline, End of treatment (63 months) | ITT population with data available at specified timepoint. | Scores on scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From the date of first dose up to approximately 74 months | Safety Analysis Set (SAF): The SAF consisted of all participants who received at least 1 dose of study treatment (gilteritinib or salvage chemotherapy). | Participants | NUMBER |
| SECONDARY | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores | Baseline, end of treatment visit (63 months) | SAF population with available data at specified timepoint. | Participants | NUMBER |
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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GET https://conductscience.org/api/trials/v1/NCT03182244/outcomes