TriangleNCT01511562 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants w/out event
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 years
What was measured
The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
Groups in this outcome
Arm I
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \> \> thiotepa: Given IV \> \> stem cell transplant \> \> G-CSF
Arm II
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \> \> cytarabine: Given IV \> \> etoposide: Given IV \> \> G-CSF
| Group | Source count |
|---|---|
| Arm I | 54 |
| Arm II | 54 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I | 72.9 | Not reported | 58.5 | 83.0 | Not reported |
| Arm II | 50.6 | Not reported | 36.1 | 63.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58.5
- upper Limit
- 83.0
- value
- 72.9
- group Id
- OG001
- lower Limit
- 36.1
- upper Limit
- 63.3
- value
- 50.6
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \> \> thiotepa: Given IV \> \> stem cell transplant \> \> G-CSF
- id
- OG000
- title
- Arm I
- description
- Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \> \> cytarabine: Given IV \> \> etoposide: Given IV \> \> G-CSF
- id
- OG001
- title
- Arm II
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Progression Free Survival
- type
- PRIMARY
- unit Of Measure
- percentage of participants w/out event
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice