NCT03219333 · OUTCOME
Overall Survival (OS): Final Analysis
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
- Cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); Cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)
What was measured
OS is defined as the time from first dose of enfortumab vedotin to death from any cause.
Analysis population: Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Groups in this outcome
Enfortumab Vedotin - Cohort 1
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Enfortumab Vedotin - Cohort 2
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
| Group | Source count |
|---|---|
| Enfortumab Vedotin - Cohort 1 | 125 |
| Enfortumab Vedotin - Cohort 2 | 89 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin - Cohort 1 | 12.4 | Not reported | 9.46 | 15.57 | Not reported |
| Enfortumab Vedotin - Cohort 2 | 15.6 | Not reported | 11.24 | 20.37 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.46
- upper Limit
- 15.57
- value
- 12.4
- group Id
- OG001
- lower Limit
- 11.24
- upper Limit
- 20.37
- value
- 15.6
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 89
- units
- Participants
- description
- OS is defined as the time from first dose of enfortumab vedotin to death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- id
- OG000
- title
- Enfortumab Vedotin - Cohort 1
- description
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- id
- OG001
- title
- Enfortumab Vedotin - Cohort 2
- param Type
- MEDIAN
- population Description
- Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
- reporting Status
- POSTED
- time Frame
- Cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); Cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)
- title
- Overall Survival (OS): Final Analysis
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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