TriangleNCT03785964 · OUTCOME
Progression Free Survival (PFS) Defined as the Time From Randomization Until Date of Assessment of Progression or Death by Any Cause.
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
- On the first day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, assessed up to approximately 2 years
What was measured
Progression will be determined radiographically using RECIST v1.1 (Eisenhauer, 2009) or clinically as assessed by the investigator. Clinical progression is defined as the onset or worsening of symptoms resulting in a global deterioration of health status causing the permanent discontinuation from study treatment and the initiation of emergent treatment (e.g., radiotherapy, surgery, or systemic therapy including chemotherapy or tyrosine kinase inhibitors) for DT/AF. Events of clinical progression will be adjudicated by an independent blinded central Endpoint Adjudication Committee (EAC) which will qualify events of clinical progression for inclusion in the PFS endpoint prior to study unblinding according to an EAC Review Charter.
Analysis population: Intent-to-Treat Population (All Randomized)
Groups in this outcome
Double-Blind Phase - Nirogacestat
Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
Double-Blind Phase - Placebo
Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
| Group | Source count |
|---|---|
| Double-Blind Phase - Nirogacestat | 70 |
| Double-Blind Phase - Placebo | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Double-Blind Phase - Nirogacestat | NA | Not reported | NA | NA | Not reached. Only less than 50% of the participants had events in Nirogacestat treatment arm. |
| Double-Blind Phase - Placebo | 15.1 | Not reported | 8.4 | NA | Upper 95% CI is not reached. |
Source statistical analyses
- ci Lower Limit
- 0.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.55
- group Description
- Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.29
- statistical Comment
- p-value was from a one-sided stratified log-rank test with placebo as reference.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.55
- group Description
- Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.29
- statistical Comment
- p-value was from a one-sided stratified log-rank test with placebo as reference.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Not reached. Only less than 50% of the participants had events in Nirogacestat treatment arm.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper 95% CI is not reached.
- group Id
- OG001
- lower Limit
- 8.4
- upper Limit
- NA
- value
- 15.1
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- Progression will be determined radiographically using RECIST v1.1 (Eisenhauer, 2009) or clinically as assessed by the investigator. Clinical progression is defined as the onset or worsening of symptoms resulting in a global deterioration of health status causing the permanent discontinuation from study treatment and the initiation of emergent treatment (e.g., radiotherapy, surgery, or systemic therapy including chemotherapy or tyrosine kinase inhibitors) for DT/AF. Events of clinical progression will be adjudicated by an independent blinded central Endpoint Adjudication Committee (EAC) which will qualify events of clinical progression for inclusion in the PFS endpoint prior to study unblinding according to an EAC Review Charter.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
- id
- OG000
- title
- Double-Blind Phase - Nirogacestat
- description
- Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
- id
- OG001
- title
- Double-Blind Phase - Placebo
- param Type
- MEDIAN
- population Description
- Intent-to-Treat Population (All Randomized)
- reporting Status
- POSTED
- time Frame
- On the first day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, assessed up to approximately 2 years
- title
- Progression Free Survival (PFS) Defined as the Time From Randomization Until Date of Assessment of Progression or Death by Any Cause.
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice