NCT02094573 · OUTCOME
Pre-dose Brigatinib Plasma Concentration
A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib · Source last updated 2021-03-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/ml
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 Cycles 2, 3, 4 and 5 (each Cycle of 28-days) pre-dose
Analysis population: ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.
Groups in this outcome
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
Brigatinib 90 mg - 180 mg
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Brigatinib 90 mg | 112 |
|---|
| Brigatinib 90 mg - 180 mg | 110 |
|---|
Reported measurements
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Brigatinib 90 mg | 101 |
|---|
| Brigatinib 90 mg - 180 mg | 97 |
|---|
Values in ng/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brigatinib 90 mg | 295.2 | 252.0 | Not reported | Not reported | Not reported |
|---|
| Brigatinib 90 mg - 180 mg | 520.0 | 321.9 | Not reported | Not reported | Not reported |
|---|
Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Brigatinib 90 mg | 91 |
|---|
| Brigatinib 90 mg - 180 mg | 92 |
|---|
Values in ng/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brigatinib 90 mg | 263.9 | 238.9 | Not reported | Not reported | Not reported |
|---|
| Brigatinib 90 mg - 180 mg | 537.0 | 360.3 | Not reported | Not reported | Not reported |
|---|
Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Brigatinib 90 mg | 80 |
|---|
| Brigatinib 90 mg - 180 mg | 87 |
|---|
Values in ng/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brigatinib 90 mg | 236.1 | 188.0 | Not reported | Not reported | Not reported |
|---|
| Brigatinib 90 mg - 180 mg | 564.7 | 415.0 | Not reported | Not reported | Not reported |
|---|
Cycle 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Brigatinib 90 mg | 80 |
|---|
| Brigatinib 90 mg - 180 mg | 79 |
|---|
Values in ng/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brigatinib 90 mg | 256.4 | 282.3 | Not reported | Not reported | Not reported |
|---|
| Brigatinib 90 mg - 180 mg | 579.7 | 396.7 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 252.0
- value
- 295.2
- group Id
- OG001
- spread
- 321.9
- value
- 520.0
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 97
- units
- Participants
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 238.9
- value
- 263.9
- group Id
- OG001
- spread
- 360.3
- value
- 537.0
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 92
- units
- Participants
- title
- Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 188.0
- value
- 236.1
- group Id
- OG001
- spread
- 415.0
- value
- 564.7
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 87
- units
- Participants
- title
- Cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 282.3
- value
- 256.4
- group Id
- OG001
- spread
- 396.7
- value
- 579.7
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 79
- units
- Participants
- title
- Cycle 5
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 110
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
- id
- OG000
- title
- Brigatinib 90 mg
- description
- Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
- id
- OG001
- title
- Brigatinib 90 mg - 180 mg
- param Type
- MEAN
- population Description
- ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Day 1 Cycles 2, 3, 4 and 5 (each Cycle of 28-days) pre-dose
- title
- Pre-dose Brigatinib Plasma Concentration
- type
- SECONDARY
- unit Of Measure
- ng/ml
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Preserved source evidence · Not medical advice
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