Trial · NCT01284348
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Hematopoietic Response | Up to Day 28 | All participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 6 months | All participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression (TTP) | Up to 6 months | TTP was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed. | ||
| SECONDARY | Progression Free Survival (PFS) | Up to 12 months | PFS was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed. | ||
| SECONDARY | Overall Survival (OS) | Up to 24 months | OS was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed. | ||
| SECONDARY | Overall Response Rate (ORR) | Up to 12 months | ORR was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed. | ||
| SECONDARY | Number of Participants Who Experienced an Improvement in Quality of Life Scores | Up to 6 months | Quality of Life parameters were to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed. | ||
| SECONDARY | Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 28 | All participants who received at least 1 dose of study treatment and had data for AUC0-28d of Sotatercept Following a Single Dose | day*ng/mL | MEAN |
| SECONDARY | Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | All participants who received at least 1 dose of study treatment and had data for AUC0-inf of Sotatercept Following a Single Dose | day*ng/mL | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | All participants who received at least 1 dose of study treatment and had data for Cmax of Sotatercept Following a Single Dose | ng/mL | MEAN |
| SECONDARY | Time to Maximum Concetration (Tmax) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | All participants who received at least 1 dose of study treatment and had data for Tmax of Sotatercept Following a Single Dose of Sotatercept | Days | MEAN |
| SECONDARY | Apparent Terminal Half-life (t1/2) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | All participants who received at least 1 dose of study treatment and had data for t1/2 of Sotatercept Following a Single Dose | Days | MEAN |
| SECONDARY | Apparent Serum Clearance (CL/F) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | All participants who received at least 1 dose of study treatment and had data for CL/F of Sotatercept Following a Single Dose | mL/day | MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) Following a Single Dose of Sotatercept | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | All participants who received at least 1 dose of study treatment and had data for Vz/F of Sotatercept Following a Single Dose | mL | 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.
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GET https://conductscience.org/api/trials/v1/NCT01284348/outcomes