NCT03332017 · OUTCOME
Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanograms per milliliter (ng/ml)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose)
Analysis population: The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement.
Groups in this outcome
Zanubrutinib + Obinutuzumab
Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
| Group | Source count |
|---|---|
| Zanubrutinib + Obinutuzumab | 137 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib + Obinutuzumab | 299.83 | 134.12 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 134.12
- value
- 299.83
- denoms
- counts
- group Id
- OG000
- value
- 137
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
- id
- OG000
- title
- Zanubrutinib + Obinutuzumab
- param Type
- MEAN
- population Description
- The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose)
- title
- Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/ml)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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