NCT05460273 · OUTCOME
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- day*ng/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 MAAA-1181a\_Area under the curve
Analysis population: PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd. The analysis for AUC was based on the patients with intensive PK collection of each cohort.
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 | 17.60 | 24.64 | Not reported | Not reported | Not reported |
| NSCLC Cohort | 17.66 | 33.09 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.64
- value
- 17.60
- group Id
- OG001
- spread
- 33.09
- value
- 17.66
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- PK parameters of MAAA-1181a\_Area under the curve
- 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. The analysis for AUC was based on the patients with intensive PK collection of each cohort.
- 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: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a
- type
- SECONDARY
- unit Of Measure
- day*ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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