NCT04985604 · OUTCOME
Duration of Response (DOR) in Participants With Best Overall Response
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
- Up to 23 months
What was measured
Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method.
Analysis population: Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.
Groups in this outcome
Melanoma Cohort
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
Tissue Agnostic Cohort
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
| Group | Source count |
|---|---|
| Melanoma Cohort | 4 |
| Tissue Agnostic Cohort | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melanoma Cohort | 5.6 | Not reported | 3.0 | NA | The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve. |
| Tissue Agnostic Cohort | 9.2 | Not reported | 3.5 | NA | The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
- group Id
- OG000
- lower Limit
- 3.0
- upper Limit
- NA
- value
- 5.6
- comment
- The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- NA
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
- id
- OG000
- title
- Melanoma Cohort
- description
- Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
- id
- OG001
- title
- Tissue Agnostic Cohort
- param Type
- MEDIAN
- population Description
- Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.
- reporting Status
- POSTED
- time Frame
- Up to 23 months
- title
- Duration of Response (DOR) in Participants With Best Overall Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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