NCT02075840 · OUTCOME
Time to Reach Cmax (Tmax) of Alectinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Analysis population: The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
Groups in this outcome
Alectinib
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
| Group | Source count |
|---|---|
| Alectinib | 144 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Alectinib | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 6.03 | Not reported | 1.98 | 12.00 | Not reported |
Treatment - week 4
| Group | Source count |
|---|---|
| Alectinib | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 4.02 | Not reported | 2.00 | 8.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.98
- upper Limit
- 12.00
- value
- 6.03
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.00
- upper Limit
- 8.00
- value
- 4.02
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- title
- Treatment - week 4
- denoms
- counts
- group Id
- OG000
- value
- 144
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG000
- title
- Alectinib
- param Type
- MEDIAN
- population Description
- The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
- reporting Status
- POSTED
- time Frame
- Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
- title
- Time to Reach Cmax (Tmax) of Alectinib
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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