TriangleNCT01343277 · 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
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
What was measured
The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Analysis population: Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).
Groups in this outcome
Trabectedin
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine
Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
| Group | Source count |
|---|---|
| Trabectedin | 384 |
| Dacarbazine | 193 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trabectedin | 13.73 | Not reported | 12.16 | 16.00 | Not reported |
| Dacarbazine | 13.14 | Not reported | 9.10 | 16.23 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.16
- upper Limit
- 16.00
- value
- 13.73
- group Id
- OG001
- lower Limit
- 9.10
- upper Limit
- 16.23
- value
- 13.14
- denoms
- counts
- group Id
- OG000
- value
- 384
- group Id
- OG001
- value
- 193
- units
- Participants
- description
- The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
- id
- OG000
- title
- Trabectedin
- description
- Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
- id
- OG001
- title
- Dacarbazine
- param Type
- MEDIAN
- population Description
- Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).
- reporting Status
- POSTED
- time Frame
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice