Trial · NCT01243944
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants Achieving a Primary Response at Week 32 | 32 Weeks | Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32). |
| Secondary | The Percentage of Participants Achieving a Durable Primary Response at Week 48 | 48 Weeks | Durable Primary Response was defined as any participant who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization. |
| Secondary | The Percentage of Participants Achieving Complete Hematological Remission at Week 32 | 32 Weeks | Complete Hematological Remission at Week 32 was defined as any participant who achieved hematocrit control with a platelet count less than or equal to 400 X 10\^9/L and a white blood cell count less than or equal to 10 X 10\^9/L. |
| Secondary | The Percentage of Participants Who Achieved a Durable Complete Hematological Remission at Week 48 | 48 Weeks | Durable Complete Hematological Remission was defined as any participant who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization. |
| Secondary | The Percentage of Participants Who Achieved a Durable Hematocrit Control at Week 48 | 48 Weeks | Durable Hematocrit Control was defined as any participant who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization. |
| Secondary | The Percentage of Participants Who Achieved Durable Spleen Volume Reduction at Week 48 | 48 Weeks | Durable Spleen Volume Reduction was defined as a participant who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization. |
| Secondary | Estimated Duration of the Primary Response | Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study | Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response). Kaplan-Meier estimates are provided for duration of primary response. |
| Secondary | The Percentage of Participants Who Achieved Overall Clinicohematologic Response at Week 32 | 32 Weeks | Overall Clinicohematologic Response is defined as any participant who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria. |
| Secondary | The Percentage of Participants Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48 | 48 Weeks | Durable Complete or Partial Clinicohematologic Response was defined as any participant who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization. |
| Secondary | Estimated Duration of the Complete Hematological Remission | Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study | Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response). Kaplan-Meier estimates are provided for duration of complete hematological remission. |
| Secondary | Duration of the Absence of Phlebotomy Eligibility | 256 Weeks | Duration of the absence of phlebotomy eligibility is defined as the time from the first occurrence of absence of phlebotomy eligibility until the date of the first documented progression. |
| Secondary | Duration of Reduction in Spleen Volume | 256 Weeks | Duration of spleen volume reduction is defined as the time from the first occurrence of a \>=35% reduction from baseline in spleen volume until the date of the first documented progression. |
| Secondary | Duration of The Overall Clinicohematologic Response | 256 Weeks | Duration of the overall clinicohematologic response was defined as the time from the first occurrence of complete response (CR) or partial response (PR) until the date of the first documented disease progression. |
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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