Trial · NCT04551963
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 | Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The pharmacokinetic (PK) analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm A: Maximum Observed Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Maximum Observed Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm A: Time of the Maximum Observed Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | Hours | MEDIAN |
| PRIMARY | Arm B: Time of the Maximum Observed Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | Hours | MEDIAN |
| PRIMARY | Arm A: Apparent Terminal Elimination Half-life (t1/2) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | Hours | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Apparent Terminal Elimination Half-life (t1/2) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated). | Hours | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Experiencing Adverse Events (AEs) | From the date of first study drug administration to 30 days after last dose (up to approximately 15 months) | The safety analysis set included all participants who were enrolled and received any dose of zanubrutinib | 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/NCT04551963/outcomes