TriangleNCT02989857 · OUTCOME
Overall Survival (OS)
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 randomization until the date of death due to any cause (Up to approximately 2 years)
What was measured
Overall survival was defined as the time in months from date of randomization to the date of death due to any cause. Participants without documentation of death at the time of the final collection were censored at the date the participant was last known to be alive, or the final collection date, whichever is earlier.
Analysis population: ITT population included all participants who were randomized, with the treatment group designated according to the randomization.
Groups in this outcome
AG-120
Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
Placebo
Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
| Group | Source count |
|---|---|
| AG-120 | 126 |
| Placebo | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 10.3 | Not reported | 7.8 | 12.4 | Not reported |
| Placebo | 7.5 | Not reported | 4.8 | 11.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.12
- estimate Comment
- Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.093
- p Value Comment
- P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.79
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.12
- estimate Comment
- Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.093
- p Value Comment
- P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.79
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.8
- upper Limit
- 12.4
- value
- 10.3
- group Id
- OG001
- lower Limit
- 4.8
- upper Limit
- 11.1
- value
- 7.5
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- Overall survival was defined as the time in months from date of randomization to the date of death due to any cause. Participants without documentation of death at the time of the final collection were censored at the date the participant was last known to be alive, or the final collection date, whichever is earlier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
- id
- OG000
- title
- AG-120
- description
- Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- ITT population included all participants who were randomized, with the treatment group designated according to the randomization.
- reporting Status
- POSTED
- time Frame
- From date of randomization until the date of death due to any cause (Up to approximately 2 years)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice