TriangleNCT03576131 · OUTCOME
Overall Survival (OS) According to RECIST 1.1
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 Day 1 through 8.8 months (corresponding to maximum observed duration)
What was measured
Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.
Analysis population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Groups in this outcome
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
| Group | Source count |
|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 10 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 7.0 | Not reported | 2.3 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 6.4 | Not reported | 1.8 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4.9 | Not reported | NA | NA | 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 7.1 | Not reported | 1.7 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 4.7 | Not reported | 2.8 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 6.9 | Not reported | NA | NA | 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- NA
- value
- 7.0
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- NA
- value
- 6.4
- comment
- 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.9
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG003
- lower Limit
- 1.7
- upper Limit
- NA
- value
- 7.1
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG004
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 4.7
- comment
- 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.9
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
- id
- OG000
- title
- Biweekly Regimen (GEN1029 0.1 mg/kg)
- description
- Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG001
- title
- Biweekly Regimen (GEN1029 0.2 mg/kg)
- description
- Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG002
- title
- Biweekly Regimen (GEN1029 0.3 mg/kg)
- description
- Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG003
- title
- Biweekly Regimen (GEN1029 1.0 mg/kg)
- description
- Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG004
- title
- Biweekly Regimen (GEN1029 2.0 mg/kg)
- description
- Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG005
- title
- Biweekly Regimen (GEN1029 3.0 mg/kg)
- param Type
- MEDIAN
- population Description
- Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 8.8 months (corresponding to maximum observed duration)
- title
- Overall Survival (OS) According to RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice