TriangleNCT01343277 · OUTCOME
Progression-Free Survival (PFS)
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 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
What was measured
The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
Analysis population: Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
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 | 345 |
| Dacarbazine | 173 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trabectedin | 4.21 | Not reported | 2.99 | 4.83 | Not reported |
| Dacarbazine | 1.54 | Not reported | 1.48 | 2.60 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.99
- upper Limit
- 4.83
- value
- 4.21
- group Id
- OG001
- lower Limit
- 1.48
- upper Limit
- 2.60
- value
- 1.54
- denoms
- counts
- group Id
- OG000
- value
- 345
- group Id
- OG001
- value
- 173
- units
- Participants
- description
- The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.
- 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 interim analysis cut-off date (16 September 2013). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
- reporting Status
- POSTED
- time Frame
- approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])
- title
- Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice