TriangleNCT03474107 · 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 randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
What was measured
OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.
Analysis population: FAS Population
Groups in this outcome
Enfortumab Vedotin 1.25 mg/kg
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Chemotherapy
Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
| Group | Source count |
|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 301 |
| Chemotherapy | 307 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin 1.25 mg/kg | 12.88 | Not reported | 10.58 | 15.21 | Not reported |
| Chemotherapy | 8.97 | Not reported | 8.05 | 10.74 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.556
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.886
- estimate Comment
- Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00142
- p Value Comment
- Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.
- param Type
- Stratified Hazard Ratio
- param Value
- 0.702
- statistical Method
- Stratified Log rank
Complete source fields
- analyses
- ci Lower Limit
- 0.556
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.886
- estimate Comment
- Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00142
- p Value Comment
- Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.
- param Type
- Stratified Hazard Ratio
- param Value
- 0.702
- statistical Method
- Stratified Log rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.58
- upper Limit
- 15.21
- value
- 12.88
- group Id
- OG001
- lower Limit
- 8.05
- upper Limit
- 10.74
- value
- 8.97
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 307
- units
- Participants
- description
- OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
- id
- OG000
- title
- Enfortumab Vedotin 1.25 mg/kg
- description
- Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- FAS Population
- reporting Status
- POSTED
- time Frame
- From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice