NCT05460273 · OUTCOME
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ug/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
What was measured
PK parameters of Dato-DXd\_Maximum observed concentration
Analysis population: PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.
Groups in this outcome
TNBC Cohort
Final Analysis with DCO on 06May2024
NSCLC Cohort
Final Analysis with DCO on 27Nov2024
| Group | Source count |
|---|---|
| TNBC Cohort | 8 |
| NSCLC Cohort | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TNBC Cohort | 150.9 | 12.73 | Not reported | Not reported | Not reported |
| NSCLC Cohort | 108.7 | 11.30 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.73
- value
- 150.9
- group Id
- OG001
- spread
- 11.30
- value
- 108.7
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- PK parameters of Dato-DXd\_Maximum observed concentration
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Final Analysis with DCO on 06May2024
- id
- OG000
- title
- TNBC Cohort
- description
- Final Analysis with DCO on 27Nov2024
- id
- OG001
- title
- NSCLC Cohort
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.
- reporting Status
- POSTED
- time Frame
- TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
- title
- Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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