TriangleNCT04744831 · OUTCOME
Duration of Response 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
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first documented evidence of a response (complete or partial) until disease progression or death, up to approximately 19 months.
What was measured
DoR, defined as time from the initial response (CR or PR) by BICR and Investigator assessment until documented tumor progression or death from any cause. DoR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
Analysis population: DoR 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 | 5.5 | Not reported | 4.2 | 8.1 | Not reported |
| T-DXd 6.4 mg/kg Q3W | 5.5 | Not reported | 3.7 | NA | Not estimable due to insufficient data. |
Investigator
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd 5.4 mg/kg Q3W | 5.6 | Not reported | 4.2 | 8.0 | Not reported |
| T-DXd 6.4 mg/kg Q3W | 6.9 | Not reported | 4.9 | 9.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 8.1
- value
- 5.5
- comment
- Not estimable due to insufficient data.
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- NA
- value
- 5.5
- title
- BICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 8.0
- value
- 5.6
- group Id
- OG001
- lower Limit
- 4.9
- upper Limit
- 9.9
- value
- 6.9
- title
- Investigator
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- DoR, defined as time from the initial response (CR or PR) by BICR and Investigator assessment until documented tumor progression or death from any cause. DoR 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
- MEDIAN
- population Description
- DoR 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 the first documented evidence of a response (complete or partial) until disease progression or death, up to approximately 19 months.
- title
- Duration of Response 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
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice