TriangleNCT04035486 · OUTCOME
Mean Cmin,ss and Mean Cmax,ss of AZ5104 (Randomized Component)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nmol/L
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Up to approximately 33 months after the first patient is randomized.
What was measured
Cmin,ss is the minimum plasma concentration of AZ5104 at steady state. Cmax,ss is the maximum plasma concentration of AZ5104 at steady state.
Analysis population: Pharmacokinetic Analysis Set, includes all randomized participants that received at least 1 dose of study treatment, have at least 1 measurable PK concentration and no missing doses 7 days prior to the PK sample, without any protocol deviation that affects PK, supported by the relevant date and time of this sample.
Groups in this outcome
Randomized: AZD9291 + Chemo
Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
Randomized: AZD9291
Osimertinib (AZD9291) 80mg QD.
| Group | Source count |
|---|---|
| Randomized: AZD9291 + Chemo | 179 |
| Randomized: AZD9291 | 233 |
Reported measurements
Cmin,ss
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | 45.34 | 59.51 | Not reported | Not reported | Not reported |
| Randomized: AZD9291 | 42.70 | 49.42 | Not reported | Not reported | Not reported |
Cmax,ss
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: AZD9291 + Chemo | 59.07 | 59.80 | Not reported | Not reported | Not reported |
| Randomized: AZD9291 | 55.59 | 46.26 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 59.51
- value
- 45.34
- group Id
- OG001
- spread
- 49.42
- value
- 42.70
- title
- Cmin,ss
- categories
- measurements
- group Id
- OG000
- spread
- 59.80
- value
- 59.07
- group Id
- OG001
- spread
- 46.26
- value
- 55.59
- title
- Cmax,ss
- denoms
- counts
- group Id
- OG000
- value
- 179
- group Id
- OG001
- value
- 233
- units
- Participants
- description
- Cmin,ss is the minimum plasma concentration of AZ5104 at steady state. Cmax,ss is the maximum plasma concentration of AZ5104 at steady state.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
- id
- OG000
- title
- Randomized: AZD9291 + Chemo
- description
- Osimertinib (AZD9291) 80mg QD.
- id
- OG001
- title
- Randomized: AZD9291
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Analysis Set, includes all randomized participants that received at least 1 dose of study treatment, have at least 1 measurable PK concentration and no missing doses 7 days prior to the PK sample, without any protocol deviation that affects PK, supported by the relevant date and time of this sample.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months after the first patient is randomized.
- title
- Mean Cmin,ss and Mean Cmax,ss of AZ5104 (Randomized Component)
- type
- SECONDARY
- unit Of Measure
- nmol/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice