TriangleNCT02989857 · OUTCOME
Duration of Response (DOR) as Assessed by the Investigator
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 the date of first confirmed CR or PR to disease progression or death regardless of cause (Up to approximately 2 years)
What was measured
DOR was defined as the time in months from date of first documented CR or PR to date of first documented disease progression or death due to any cause, whichever is earlier, as assessed by the Investigator per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis \<10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Participants with response and without progression were censored at the last observation.
Analysis population: Participants with CR or PR per investigator assessment by the data cutoff date (31 January 2019) for the analysis of tumor response.
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 | 4 |
| Placebo | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | NA | Not reported | NA | NA | Median, lower limit and upper limit were not available due to the insufficient number of participants with events. |
| Placebo | NA | Not reported | NA | NA | Median, lower limit and upper limit were not available due to the insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median, lower limit and upper limit were not available due to the insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median, lower limit and upper limit were not available due to the insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- DOR was defined as the time in months from date of first documented CR or PR to date of first documented disease progression or death due to any cause, whichever is earlier, as assessed by the Investigator per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis \<10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Participants with response and without progression were censored at the last observation.
- 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
- Participants with CR or PR per investigator assessment by the data cutoff date (31 January 2019) for the analysis of tumor response.
- reporting Status
- POSTED
- time Frame
- From the date of first confirmed CR or PR to disease progression or death regardless of cause (Up to approximately 2 years)
- title
- Duration of Response (DOR) as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice