Trial · NCT01749540
Outcomes58
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 58
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Non-transfusion Dependent (NTD) Participants With a Hemoglobin Increase of ≥1.5 g/dL From Baseline for ≥14 Days | Up to approximately 20 weeks | All participants who received ≥1 dose of study treatment and received \<4 units of RBCs within 8 weeks prior to the first dose of study drug and had data available for the analyses | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Transfusion Dependent (TD) Participants With a ≥20% Reduction in Red Blood Cell (RBC) Transfusion Burden From Baseline During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received ≥4 units of RBCs every 8 weeks (confirmed over 6 months prior to the first dose of study drug) and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 20 weeks | All participants who received ≥1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Serious Adverse Event (SAE) | Up to approximately 20 weeks | All participants who received ≥1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) of Grade 3 or Greater | Up to approximately 20 weeks | All participants who received ≥1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE) | Up to approximately 12 weeks | All participants who received ≥1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Up to 28 days | The DLT analysis population consisted of all participants who received ≥1 dose of study treatment and were observed for DLTs for 28 days after the first dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Non-transfusion Dependent (NTD) Participants With a Hemoglobin Increase of ≥1.0 g/dL From Baseline During a Rolling 8-week Interval | Any 8-week interval during the study (up to approximately 20 Weeks) | All participants who received ≥1 dose of study treatment and received \<4 units of RBCs within 8 weeks prior to the first dose of study drug and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Non-transfusion Dependent (NTD) Participants With a Hemoglobin Increase of ≥1.5 g/dL From Baseline During a Rolling 8-week Interval | Any 8-week interval during the study (up to approximately 20 Weeks) | All participants who received ≥1 dose of study treatment and received \<4 units of RBCs within 8 weeks prior to the first dose of study drug and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Non-transfusion Dependent (NTD) Participants With a Hemoglobin Increase of ≥1.0 g/dL From Baseline During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 Weeks) | All participants who received ≥1 dose of study treatment and received \<4 units of RBCs within 8 weeks prior to the first dose of study drug and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Non-transfusion Dependent (NTD) Participants With a Hemoglobin Increase of ≥1.5 g/dL From Baseline During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 Weeks) | All participants who received ≥1 dose of study treatment and received \<4 units of RBCs within 8 weeks prior to the first dose of study drug and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Transfusion Dependent (TD) Participants With a ≥50% Reduction in Red Blood Cell (RBC) Transfusion Burden From Baseline During a Rolling 8-week Interval | Any 8-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received ≥4 units of RBCs every 8 weeks (confirmed over 6 months prior to the first dose of study drug) and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Transfusion Dependent (TD) Participants With a ≥50% Reduction in Red Blood Cell (RBC) Transfusion Burden From Baseline During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received ≥4 units of RBCs every 8 weeks (confirmed over 6 months prior to the first dose of study drug) and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Transfusion Dependent (TD) Participants Who Maintained Red Blood Cell (RBC) Transfusion Independence For ≥8 Weeks | Any 8-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received ≥4 units of RBCs every 8 weeks (confirmed over 6 months prior to the first dose of study drug) and had data available for the analyses | Percentage of participants | NUMBER |
| SECONDARY | Time To Erythroid Response for Non-transfusion Dependent (NTD) Participants Who Achieved a Hemoglobin Increase ≥1.0 g/dL During a Rolling 12-week Interval by Pooled Dose Groups | Any 12-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received \<4 units of red blood cells (RBCs) within 8 weeks prior to the first dose of study drug and had data available for the analyses. As defined in the clinical study report, the participants with response were pooled into low and high dose groups to reduce the variation of the analyses. | Days | MEAN |
| SECONDARY | Time To Erythroid Response for Transfusion Dependent (TD) Participants Who Achieved a Transfusion Burden Reduction of ≥50% During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and have received ≥4 units of RBCs every 8 weeks (confirmed over 6 months prior to the first dose of study drug) and had data available for the analyses. As defined in the clinical study report, the participants with response were pooled into low and high dose groups to reduce the variation of the analyses. | Days | MEAN |
| SECONDARY | Duration of Erythroid Response for Non-transfusion Dependent (NTD) Participants Who Achieved a Hemoglobin Increase ≥1.0 g/dL During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received \<4 units of red blood cells (RBCs) within 8 weeks prior to the first dose of study drug and had data available for the analyses. As defined in the clinical study report, the participants with response were pooled into low and high dose groups to reduce the variation of the analyses. | Days | MEAN |
| SECONDARY | Duration of Erythroid Response for Transfusion Dependent (TD) Participants Who Achieved a Transfusion Burden Reduction of ≥50% During a Rolling 12-week Interval | Any 12-week interval during the study (up to approximately 20 weeks) | All participants who received ≥1 dose of study treatment and received ≥4 units of RBCs every 8 weeks (confirmed over 6 months prior to the first dose of study drug) and had data available for the analyses. As defined in the clinical study report, the participants with response were pooled into low and high dose groups to reduce the variation of the analyses. | Days | MEAN |
| SECONDARY | Percent Change From Baseline to End of Treatment in Mean Bone-specific Alkaline Phosphatase (BSAP) | Baseline (prior to first dose of study drug) and End of Treatment (up to Day 113) | All participants who received ≥1 dose of study treatment and had data available for BSAP analyses | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline to End of Treatment in Mean C-telopeptide of Type I Collagen (CTX) | Baseline (prior to first dose of study drug) and End of Treatment (up to Day 113) | All participants who received ≥1 dose of study treatment and had data available for CTX analyses | Percent change | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01749540/outcomes