NCT06039384 · OUTCOME
Kaplan-Meier Estimate of ≥6-month and ≥12-month Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- ≥6-months and ≥12-months (up to 470 days)
What was measured
≥6-month and ≥12-month PFS was defined as the absence of disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause from the start of treatment to ≥6 or ≥12 months after treatment. A Kaplan-Meier estimate of PFS is an estimate of the probability that a participant will remain alive and free from disease progression (or relapse) at a given time point after starting treatment.
Analysis population: Full Analysis Set. PFS rates were estimated using the Kaplan-Meier method. Confidence intervals for PFS rates were calculated using the Greenwood formula with log-log transformation.
Groups in this outcome
INCB099280 50 mg QD Plus Adagrasib 400 mg BID
Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
INCB099280 100 mg BID Plus Adagrasib 400 mg BID
Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
| Group | Source count |
|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 3 |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 3 |
Reported measurements
Kaplan-Meier estimated probability of PFS ≥6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 100.0 | Not reported | NA | NA | Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points. |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 0.0 | Not reported | NA | NA | Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points. |
Kaplan-Meier estimated probability of PFS ≥12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 100.0 | Not reported | NA | NA | Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points. |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 0.0 | Not reported | NA | NA | Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points. |
Complete source fields
- classes
- categories
- measurements
- comment
- Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 100.0
- comment
- Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0.0
- title
- Kaplan-Meier estimated probability of PFS ≥6 months
- categories
- measurements
- comment
- Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 100.0
- comment
- Variance of Kaplan-Meier estimates cannot be calculated per Greenwood's formula when Kaplan-Meier estimates are 100% or 0% at specified time points.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0.0
- title
- Kaplan-Meier estimated probability of PFS ≥12 months
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- ≥6-month and ≥12-month PFS was defined as the absence of disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause from the start of treatment to ≥6 or ≥12 months after treatment. A Kaplan-Meier estimate of PFS is an estimate of the probability that a participant will remain alive and free from disease progression (or relapse) at a given time point after starting treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
- id
- OG000
- title
- INCB099280 50 mg QD Plus Adagrasib 400 mg BID
- description
- Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
- id
- OG001
- title
- INCB099280 100 mg BID Plus Adagrasib 400 mg BID
- param Type
- NUMBER
- population Description
- Full Analysis Set. PFS rates were estimated using the Kaplan-Meier method. Confidence intervals for PFS rates were calculated using the Greenwood formula with log-log transformation.
- reporting Status
- POSTED
- time Frame
- ≥6-months and ≥12-months (up to 470 days)
- title
- Kaplan-Meier Estimate of ≥6-month and ≥12-month Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- percentage probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
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