Trial · NCT00931606
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Hematopoietic Response | Baseline and Up to ~145 Days | Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~175 Days | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported. |
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | Up to ~85 Days | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported. |
| Secondary | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Baseline and Up to ~145 Days | Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented. |
| Secondary | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented. |
| Secondary | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented. |
| Secondary | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented. |
| Secondary | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented. |
| Secondary | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented. |
| Secondary | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented. |
| Secondary | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented. |
| Secondary | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Up to Day 141 | The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented. |
| Secondary | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Baseline and Day 64 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented. |
| Secondary | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Day 64 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented. |
| Secondary | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Day 113 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented. |
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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