TriangleNCT04744831 · OUTCOME
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer
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
- 6 months post-dose administration to data cut off, up to 20 months
What was measured
Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the 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: ORR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
Groups in this outcome
T-DXd 5.4 mg/kg Q3W
Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
T-DXd 6.4 mg/kg Q3W
Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
| Group | Source count |
|---|---|
| T-DXd 5.4 mg/kg Q3W | 82 |
| T-DXd 6.4 mg/kg Q3W | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 37.8 | Not reported | 27.3 | 49.2 | Not reported |
| T-DXd 6.4 mg/kg Q3W | 27.5 | Not reported | 14.6 | 43.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.3
- upper Limit
- 49.2
- value
- 37.8
- group Id
- OG001
- lower Limit
- 14.6
- upper Limit
- 43.9
- value
- 27.5
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the 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 were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- OG000
- title
- T-DXd 5.4 mg/kg Q3W
- description
- Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
- id
- OG001
- title
- T-DXd 6.4 mg/kg Q3W
- param Type
- NUMBER
- population Description
- ORR was assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
- reporting Status
- POSTED
- time Frame
- 6 months post-dose administration to data cut off, up to 20 months
- title
- Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice