TriangleNCT04656652 · OUTCOME
Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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 date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months
What was measured
DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic Progressive Disease or death due to any cause, whichever occurs first.
Analysis population: Full Analysis Set includes all randomized subjects. If a subject was randomized more than once, only one of the participants is included in the Full Analysis Set.
Groups in this outcome
DS-1062a 6.0 mg/kg
Participants were randomized to receive 6.0 mg/kg of DS-1062a.
Docetaxel 75 mg/m^2
Participants were randomized to receive 75 mg/m\^2 docetaxel.
| Group | Source count |
|---|---|
| DS-1062a 6.0 mg/kg | 299 |
| Docetaxel 75 mg/m^2 | 305 |
Reported measurements
Assessed by Blinded Independent Central Review
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DS-1062a 6.0 mg/kg | 7.1 | Not reported | 5.6 | 10.9 | Not reported |
| Docetaxel 75 mg/m^2 | 5.6 | Not reported | 5.4 | 8.1 | Not reported |
Assessed by Investigator
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DS-1062a 6.0 mg/kg | 9.6 | Not reported | 6.7 | 11.1 | Not reported |
| Docetaxel 75 mg/m^2 | 6.4 | Not reported | 5.1 | 8.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 10.9
- value
- 7.1
- group Id
- OG001
- lower Limit
- 5.4
- upper Limit
- 8.1
- value
- 5.6
- title
- Assessed by Blinded Independent Central Review
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.7
- upper Limit
- 11.1
- value
- 9.6
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 8.3
- value
- 6.4
- title
- Assessed by Investigator
- denoms
- counts
- group Id
- OG000
- value
- 299
- group Id
- OG001
- value
- 305
- units
- Participants
- description
- DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic Progressive Disease or death due to any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive 6.0 mg/kg of DS-1062a.
- id
- OG000
- title
- DS-1062a 6.0 mg/kg
- description
- Participants were randomized to receive 75 mg/m\^2 docetaxel.
- id
- OG001
- title
- Docetaxel 75 mg/m^2
- param Type
- MEDIAN
- population Description
- Full Analysis Set includes all randomized subjects. If a subject was randomized more than once, only one of the participants is included in the Full Analysis Set.
- reporting Status
- POSTED
- time Frame
- From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months
- title
- Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice