NCT01399372 · OUTCOME
Percentage of Participants Experiencing Partial Response or Complete Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- After 4th cycle of chemotherapy, approximately 4 months after randomization.
What was measured
Response was evaluated using the international criteria proposed by the International Primary Central Nervous System Lymphoma (PCNSL) Study Group criteria. Complete Response was defined as no contrast brain enhancement on magnetic resonance imaging (MRI), no corticosteroid use for at least 2 weeks, a normal eye exam, and negative CSF cytology. Partial response was defined as at least 50% decrease in enhancing tumor on MRI compared with baseline imaging, no or minor retinal pigment epithelium (RPE) abnormality, and negative CSF cytology.
Analysis population: Eligible participants with Cycle 4 disease assessment data
Groups in this outcome
Chemotherapy
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
Chemotherapy + Low-Dose WBRT
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
| Group | Source count |
|---|---|
| Chemotherapy | 30 |
| Chemotherapy + Low-Dose WBRT | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy | 83.3 | Not reported | 65.3 | 94.4 | Not reported |
| Chemotherapy + Low-Dose WBRT | 80.6 | Not reported | 62.5 | 92.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.3
- upper Limit
- 94.4
- value
- 83.3
- group Id
- OG001
- lower Limit
- 62.5
- upper Limit
- 92.5
- value
- 80.6
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- Response was evaluated using the international criteria proposed by the International Primary Central Nervous System Lymphoma (PCNSL) Study Group criteria. Complete Response was defined as no contrast brain enhancement on magnetic resonance imaging (MRI), no corticosteroid use for at least 2 weeks, a normal eye exam, and negative CSF cytology. Partial response was defined as at least 50% decrease in enhancing tumor on MRI compared with baseline imaging, no or minor retinal pigment epithelium (RPE) abnormality, and negative CSF cytology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
- id
- OG000
- title
- Chemotherapy
- description
- Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
- id
- OG001
- title
- Chemotherapy + Low-Dose WBRT
- param Type
- NUMBER
- population Description
- Eligible participants with Cycle 4 disease assessment data
- reporting Status
- POSTED
- time Frame
- After 4th cycle of chemotherapy, approximately 4 months after randomization.
- title
- Percentage of Participants Experiencing Partial Response or Complete Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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