NCT00949325 · OUTCOME
Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- up to 5 years
What was measured
Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
Analysis population: Only participants who completed at least 2 treatment cycles (14/18 participants) were included to assess this outcome measure.
Groups in this outcome
Temsirolimus 20 mg/m^2 and 27 mg/m^2
Subjects who completed at least 2 cycles of treatment with temsirolimus dose of 20 mg/m\^2 or 27 mg/m\^2 were assessed for radiologic response.
| Group | Source count |
|---|---|
| Temsirolimus 20 mg/m^2 and 27 mg/m^2 | 14 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Temsirolimus 20 mg/m^2 and 27 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Temsirolimus 20 mg/m^2 and 27 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Temsirolimus 20 mg/m^2 and 27 mg/m^2 | 8 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Temsirolimus 20 mg/m^2 and 27 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
- groups
- description
- Subjects who completed at least 2 cycles of treatment with temsirolimus dose of 20 mg/m\^2 or 27 mg/m\^2 were assessed for radiologic response.
- id
- OG000
- title
- Temsirolimus 20 mg/m^2 and 27 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only participants who completed at least 2 treatment cycles (14/18 participants) were included to assess this outcome measure.
- reporting Status
- POSTED
- time Frame
- up to 5 years
- title
- Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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