TriangleNCT03434379 · OUTCOME
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
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
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
What was measured
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Analysis population: The analysis population included Global participants with a confirmed response (CR or PR).
Groups in this outcome
Sorafenib - Global
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
| Group | Source count |
|---|---|
| Sorafenib - Global | 21 |
| Atezolizumab + Bevacizumab - Global | 108 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib - Global | 6.28 | Not reported | 4.86 | NA | NA = not estimable due to the limited number of events observed |
| Atezolizumab + Bevacizumab - Global | NA | Not reported | NA | NA | NA = not estimable due to the limited number of events observed |
Source statistical analyses
- ci Lower Limit
- 0.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.73
- group Description
- Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0048
- param Type
- Hazard Ratio (HR)
- param Value
- 0.30
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.73
- group Description
- Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0048
- param Type
- Hazard Ratio (HR)
- param Value
- 0.30
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA = not estimable due to the limited number of events observed
- group Id
- OG000
- lower Limit
- 4.86
- upper Limit
- NA
- value
- 6.28
- comment
- NA = not estimable due to the limited number of events observed
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 108
- units
- Participants
- description
- DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- id
- OG000
- title
- Sorafenib - Global
- description
- Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- id
- OG001
- title
- Atezolizumab + Bevacizumab - Global
- param Type
- MEDIAN
- population Description
- The analysis population included Global participants with a confirmed response (CR or PR).
- reporting Status
- POSTED
- time Frame
- Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
- title
- Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice