NCT00436618 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 5 years
What was measured
Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.
Analysis population: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
Groups in this outcome
Relapsed Aggressive Non-Hodgkin Lymphoma
Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Relapsed Indolent Non-Hodgkin Lymphoma
Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Uncommon Lymphomas
Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
| Group | Source count |
|---|---|
| Relapsed Aggressive Non-Hodgkin Lymphoma | 114 |
| Relapsed Indolent Non-Hodgkin Lymphoma | 55 |
| Uncommon Lymphomas | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relapsed Aggressive Non-Hodgkin Lymphoma | 0.18 | Not reported | 0.16 | 0.27 | Not reported |
| Relapsed Indolent Non-Hodgkin Lymphoma | 0.60 | Not reported | 0.41 | 1.03 | Not reported |
| Uncommon Lymphomas | 0.79 | Not reported | 0.52 | 1.09 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.16
- upper Limit
- 0.27
- value
- 0.18
- group Id
- OG001
- lower Limit
- 0.41
- upper Limit
- 1.03
- value
- 0.60
- group Id
- OG002
- lower Limit
- 0.52
- upper Limit
- 1.09
- value
- 0.79
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 107
- units
- Participants
- description
- Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- id
- OG000
- title
- Relapsed Aggressive Non-Hodgkin Lymphoma
- description
- Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- id
- OG001
- title
- Relapsed Indolent Non-Hodgkin Lymphoma
- description
- Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- id
- OG002
- title
- Uncommon Lymphomas
- param Type
- MEDIAN
- population Description
- 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- years
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