TriangleNCT04744831 · OUTCOME
Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -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
- From first dose administration to data cut off, up to approximately 19 months.
What was measured
Clinical Benefit Rate (CBR), defined as proportion of subjects who achieved CR, PR, or SD for at least 6 months; CBR based on BICR and CBR based on Investigator assessments will both be determined based on RECIST version 1.1. CBR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
Analysis population: CBR 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
BICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 45.1 | Not reported | 34.1 | 56.5 | Not reported |
| T-DXd 6.4 mg/kg Q3W | 32.5 | Not reported | 18.6 | 49.1 | Not reported |
Investigator
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 51.2 | Not reported | 39.9 | 62.4 | Not reported |
| T-DXd 6.4 mg/kg Q3W | 42.5 | Not reported | 27.0 | 59.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.1
- upper Limit
- 56.5
- value
- 45.1
- group Id
- OG001
- lower Limit
- 18.6
- upper Limit
- 49.1
- value
- 32.5
- title
- BICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.9
- upper Limit
- 62.4
- value
- 51.2
- group Id
- OG001
- lower Limit
- 27.0
- upper Limit
- 59.1
- value
- 42.5
- title
- Investigator
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Clinical Benefit Rate (CBR), defined as proportion of subjects who achieved CR, PR, or SD for at least 6 months; CBR based on BICR and CBR based on Investigator assessments will both be determined based on RECIST version 1.1. CBR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
- 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
- CBR 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
- From first dose administration to data cut off, up to approximately 19 months.
- title
- Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice