TriangleNCT01041404 · OUTCOME
Trastuzumab Minimum Serum Concentration (Cmin)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- mg/L
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
What was measured
Median Cmin (measured as milligrams per liter \[mg/L\]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.
Analysis population: PK Population
Groups in this outcome
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
| Group | Source count |
|---|---|
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 266 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 23.0 | Not reported | 6.4 | 48.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 48.5
- value
- 23.0
- denoms
- counts
- group Id
- OG000
- value
- 266
- units
- Participants
- description
- Median Cmin (measured as milligrams per liter \[mg/L\]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
- id
- OG000
- title
- Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
- param Type
- MEDIAN
- population Description
- PK Population
- reporting Status
- POSTED
- time Frame
- Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
- title
- Trastuzumab Minimum Serum Concentration (Cmin)
- type
- SECONDARY
- unit Of Measure
- mg/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice