TriangleNCT01321554 · 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
- Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
What was measured
Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.
Analysis population: The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
Groups in this outcome
Randomization Phase: Lenvatinib 24 mg
Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Randomization Phase: Placebo
Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
| Group | Source count |
|---|---|
| Randomization Phase: Lenvatinib 24 mg | 261 |
| Randomization Phase: Placebo | 131 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Lenvatinib 24 mg | NA | Not reported | 22.0 | NA | The median OS was not yet reached for either the lenvatinib or the placebo arm (including crossover participants) at data cutoff date. |
| Randomization Phase: Placebo | NA | Not reported | 14.3 | NA | The median OS was not yet reached for either the lenvatinib or the placebo arm (including crossover participants) at data cutoff date. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median OS was not yet reached for either the lenvatinib or the placebo arm (including crossover participants) at data cutoff date.
- group Id
- OG000
- lower Limit
- 22.0
- upper Limit
- NA
- value
- NA
- comment
- The median OS was not yet reached for either the lenvatinib or the placebo arm (including crossover participants) at data cutoff date.
- group Id
- OG001
- lower Limit
- 14.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 131
- units
- Participants
- description
- Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Randomization Phase: Lenvatinib 24 mg
- description
- Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Randomization Phase: Placebo
- param Type
- MEDIAN
- population Description
- The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice