Trial · NCT00931606
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved a Hematopoietic Response | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~175 Days | All participants who received at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | Up to ~85 Days | All participants who received at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study treatment for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| 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 | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥1 g/dL and less than 2 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥2 g/dL and less than 11 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥11 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL increase from baseline. | Days | MEDIAN |
| SECONDARY | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL increase from baseline. | Days | MEDIAN |
| SECONDARY | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had hematopoietic response of ≥ 11 g/dL increase from baseline. | Days | MEDIAN |
| 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 | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline. | Days | MEDIAN |
| 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 | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline. | Days | MEDIAN |
| SECONDARY | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Up to Day 141 | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| 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 | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Day 64 | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Day 113 | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response. | Percentage of 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.
For software
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