NCT00217737 · OUTCOME
Overall Survival Rate at 5 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
What was measured
Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The Kaplan-Meier estimates were used to characterize the 5-year OS rates.
Analysis population: Eligible patients who were registered or randomized at Step 2 were included in this analysis.
Groups in this outcome
Arm A (5-FU, Leucovorin, Oxaliplatin)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
Arm C (Observation)
Patients undergo observation.
| Group | Source count |
|---|---|
| Arm A (5-FU, Leucovorin, Oxaliplatin) | 424 |
| Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab) | 435 |
| Arm C (Observation) | 998 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (5-FU, Leucovorin, Oxaliplatin) | 0.918 | Not reported | 0.891 | 0.946 | Not reported |
| Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab) | 0.921 | Not reported | 0.895 | 0.948 | Not reported |
| Arm C (Observation) | 0.926 | Not reported | 0.909 | 0.943 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.891
- upper Limit
- 0.946
- value
- 0.918
- group Id
- OG001
- lower Limit
- 0.895
- upper Limit
- 0.948
- value
- 0.921
- group Id
- OG002
- lower Limit
- 0.909
- upper Limit
- 0.943
- value
- 0.926
- denoms
- counts
- group Id
- OG000
- value
- 424
- group Id
- OG001
- value
- 435
- group Id
- OG002
- value
- 998
- units
- Participants
- description
- Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The Kaplan-Meier estimates were used to characterize the 5-year OS rates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (5-FU, Leucovorin, Oxaliplatin)
- description
- Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
- description
- Patients undergo observation.
- id
- OG002
- title
- Arm C (Observation)
- param Type
- NUMBER
- population Description
- Eligible patients who were registered or randomized at Step 2 were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
- title
- Overall Survival Rate at 5 Years
- type
- SECONDARY
- unit Of Measure
- Proportion of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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