TriangleNCT00335738 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Estimated Probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 2 Years
What was measured
OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.
Analysis population: Only eligible patients are considered for this outcome measure. This is calculated as the total number of patients enrolled in each group with the number ineligible in each group subtracted as reported on the participant flow template.
Groups in this outcome
Group 1 (Identified by Central Review as High Risk)
Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
Group 2 (Identified by Central Review as Not High Risk)
Patients undergo observation periodically for at least 5 years.
| Group | Source count |
|---|---|
| Group 1 (Identified by Central Review as High Risk) | 89 |
| Group 2 (Identified by Central Review as Not High Risk) | 235 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (Identified by Central Review as High Risk) | 0.9628 | Not reported | 0.8890 | 0.9878 | Not reported |
| Group 2 (Identified by Central Review as Not High Risk) | 1 | Not reported | 1 | 1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8890
- upper Limit
- 0.9878
- value
- 0.9628
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 235
- units
- Participants
- description
- OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
- id
- OG000
- title
- Group 1 (Identified by Central Review as High Risk)
- description
- Patients undergo observation periodically for at least 5 years.
- id
- OG001
- title
- Group 2 (Identified by Central Review as Not High Risk)
- param Type
- NUMBER
- population Description
- Only eligible patients are considered for this outcome measure. This is calculated as the total number of patients enrolled in each group with the number ineligible in each group subtracted as reported on the participant flow template.
- reporting Status
- POSTED
- time Frame
- At 2 Years
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Estimated Probability
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice