Trial · NCT01736683
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Erythroid Hematological Improvement (HI-E) Starting Before the Completion of Five Cycles of Treatment (Responder Rate) | Day 2 to Day 142 | Efficacy Evaluable Population: all participants who take at least one dose of study medication and have baseline and at least one post-baseline assessment of efficacy without major deviation from protocol. | percentage of participants | NUMBER |
| SECONDARY | Time to Erythroid Hematological Improvement (HI-E) Response | Day 1 to Day 87 | Efficacy Evaluable Population of participants who responded | days | MEDIAN |
| SECONDARY | Duration of Erythroid Hematological Improvement (HI-E) | Day 1 to 183.7 weeks | Efficacy Evaluable Population of participants who responded | days | MEDIAN |
| SECONDARY | Time to Progression to Acute Myeloid Leukemia (AML) for Participants Who Had Progression | Day 1 to 183.7 weeks | Efficacy Evaluable Population of participants who progressed to AML | weeks | NUMBER |
| SECONDARY | Time to Progression to Events of Higher Risk Myelodysplastic Syndromes (MDS) Using the International Prognostic Scoring System (IPSS) For Participants Who Had Progression | Day 1 to 257.3 weeks | Efficacy Evaluable Population of participants who progressed to high risk MDS categories | weeks | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Progression-free Survival | Day 1 to 257.3 weeks | Efficacy Evaluable Population | weeks | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Overall Survival (OS) | Day 1 to 257.3 weeks | Efficacy Evaluable Population | weeks | MEDIAN |
| SECONDARY | Pharmacokinetic Parameters of Sotatercept: Serum Concentration at Various Study Timepoints | Cycle 1 Day 8 and !5 up to Cycle 2 Day 1 | Pharmacokinetic (PK) population includes participants with a sufficient amount of post-dose quantifiable PK sotatercept profile. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Participants With Treatment-Emergent Adverse Events (TEAE) | Day 1 up to 59.2 months | Safety population: all participants who receive at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Limiting Toxicities (DLTs) | Day 1 to 59.2 months | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Red Blood Cell (RBC)-Transfusion Independence During the Erythroid Hematological Improvement (HI-E) Interval | Day 2 to Day 142 | Efficacy Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
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/NCT01736683/outcomes