Trial · NCT04603495
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Splenic Response by Central Radiology Reads at Week 24 | Week 24 | Intent-to-Treat (ITT) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Key Secondary: Absolute Change From Baseline in Total Symptom Score (TSS) at Week 24 | Baseline, Week 24 | Intent-to-Treat (ITT) Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Key Secondary: Number of Participants With TSS50 Response at Week 24 | Week 24 | Intent-to-Treat (ITT) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Total Symptom Score (TSS) at Week 24 | Baseline, Week 24 | Intent-to-Treat (ITT) Analysis Set | Percent change from baseline to Week 24 | MEAN |
| SECONDARY | Number of Participants With Improvement From Baseline in Bone Marrow Fibrosis of at Least 1 Grade at Week 24 | Baseline, Week 24 | Intent-to-Treat (ITT) Analysis Set: Only participants with available data at the specified time point were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Splenic Response by Central Radiology Reads at Week 48 | Week 48 | |||
| SECONDARY | Number of Participants With TSS50 Response at Week 48 | Week 48 | |||
| SECONDARY | Absolute Change From Baseline in Total Symptom Score (TSS) at Week 48 | Baseline, Week 48 | |||
| SECONDARY | Rate of Red Blood Cell (RBC) Transfusion Over First 24 Weeks of Treatment | Week 24 | Intent-to-Treat (ITT) Analysis Set | RBC units transfused/patient-months | NUMBER |
| SECONDARY | Number of Participants Who Transitioned From Red Blood Cell (RBC) Transfusion Dependence to Transfusion Independence | From 12-week baseline period prior to dosing to any 12-week period post baseline, up to 24 weeks | Intent-to-Treat (ITT) Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Category Change From Baseline of Patient Global Impression of Change (PGIC) at Week 24 | Baseline, Week 24 | Intent-to-Treat (ITT) Analysis Set - Only participants with evaluable data at the pre-specified time points | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | Through study completion, an average of 6 years | |||
| SECONDARY | Overall Survival (OS) | Through study completion, an average of 6 years | |||
| SECONDARY | Proportion of Patients With Transformation to Blast Phase (AML) | Through study completion, an average of 6 years | |||
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Through study completion, an average of 6 years | |||
| SECONDARY | Pharmacokinetic (PK) Parameters for Pelabresib: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) | Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days | |||
| SECONDARY | Pharmacokinetic (PK) Parameters for Pelabresib: Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) | Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days | |||
| SECONDARY | Pharmacokinetic (PK) Parameters for Pelabresib: Maximum (Peak) Plasma Drug Concentration (Cmax) | Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days | |||
| SECONDARY | Pharmacokinetic (PK) Parameters for Pelabresib: Effective Half-Life (T1/2) | Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days | |||
| SECONDARY | Pharmacokinetic (PK) Parameters for Pelabresib: Apparent Volume of Distribution After Non-intravenous Administration (Vd/F) | Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days |
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/NCT04603495/outcomes