TriangleNCT02610140 · OUTCOME
Overall Survival (OS), [95% CI]
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
- Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment.
What was measured
Overall survival (OS) was defined as time from randomization until death from any cause.
Analysis population: The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set.
Groups in this outcome
Anetumab Ravtansine
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Vinorelbine
Active comparator: 30 mg/m\^2 once weekly
| Group | Source count |
|---|---|
| Anetumab Ravtansine | 166 |
| Vinorelbine | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anetumab Ravtansine | 9.5 | Not reported | 8.3 | 12.3 | Not reported |
| Vinorelbine | 11.6 | Not reported | 8.6 | 13.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.763
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.506
- estimate Comment
- Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.
- group Description
- OS anetumab ravtansine / vinorelbine
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.655624
- p Value Comment
- 1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.072
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.763
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.506
- estimate Comment
- Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.
- group Description
- OS anetumab ravtansine / vinorelbine
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.655624
- p Value Comment
- 1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.072
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 12.3
- value
- 9.5
- group Id
- OG001
- lower Limit
- 8.6
- upper Limit
- 13.1
- value
- 11.6
- denoms
- counts
- group Id
- OG000
- value
- 166
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- Overall survival (OS) was defined as time from randomization until death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
- id
- OG000
- title
- Anetumab Ravtansine
- description
- Active comparator: 30 mg/m\^2 once weekly
- id
- OG001
- title
- Vinorelbine
- param Type
- MEDIAN
- population Description
- The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set.
- reporting Status
- POSTED
- time Frame
- Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment.
- title
- Overall Survival (OS), [95% CI]
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice