TriangleNCT00335738 · OUTCOME
Event-free Survival (EFS)
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
EFS 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 in the characterization of EFS at 2 years.
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) | 0.9394 | Not reported | 0.8606 | 0.9743 | Not reported |
| Group 2 (Identified by Central Review as Not High Risk) | 0.9953 | Not reported | 0.9671 | 0.9993 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8606
- upper Limit
- 0.9743
- value
- 0.9394
- group Id
- OG001
- lower Limit
- 0.9671
- upper Limit
- 0.9993
- value
- 0.9953
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 235
- units
- Participants
- description
- EFS 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 in the characterization of EFS at 2 years.
- reporting Status
- POSTED
- time Frame
- At 2 years
- title
- Event-free Survival (EFS)
- type
- PRIMARY
- unit Of Measure
- Estimated Probability
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice