TriangleNCT04644237 · OUTCOME
Percentage of Participants With Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerTumors
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
What was measured
Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Analysis population: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
Groups in this outcome
Trastuzumab Deruxtecan 5.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
Trastuzumab Deruxtecan 6.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | 102 |
| Trastuzumab Deruxtecan 6.4 mg/kg | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | 46.1 | Not reported | 36.2 | 56.2 | Not reported |
| Trastuzumab Deruxtecan 6.4 mg/kg | 56.0 | Not reported | 41.3 | 70.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.2
- upper Limit
- 56.2
- value
- 46.1
- group Id
- OG001
- lower Limit
- 41.3
- upper Limit
- 70.0
- value
- 56.0
- denoms
- counts
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 50
- units
- Participants
- description
- Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- id
- OG000
- title
- Trastuzumab Deruxtecan 5.4 mg/kg
- description
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- id
- OG001
- title
- Trastuzumab Deruxtecan 6.4 mg/kg
- param Type
- NUMBER
- population Description
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
- reporting Status
- POSTED
- time Frame
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- title
- Percentage of Participants With Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerTumors
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice