NCT01553149 · OUTCOME
Number of Patients Who Demonstrate Complete or Partial Response
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
- 26 cycles of chemotherapy - up to 3 years after enrollment
What was measured
Number of patients who demonstrate a complete or partial response as defined below: Complete Response - Complete disappearance of all known disease for at least 4 weeks; Partial Response - A reduction of at least 50% in the size of all measurable tumor as quantitated by the sum of the products of the largest diameters of measurable lesions when compared with that measurement at the time of study enrollment and maintained for at least 4 weeks.
Analysis population: Only eligible patients are considered in the analysis of this outcome measure
Groups in this outcome
Arm I (Low-dose Lenalidomide)
Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
Arm II (High-dose Lenalidomide)
Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
| Group | Source count |
|---|---|
| Arm I (Low-dose Lenalidomide) | 37 |
| Arm II (High-dose Lenalidomide) | 37 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Low-dose Lenalidomide) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm II (High-dose Lenalidomide) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- Number of patients who demonstrate a complete or partial response as defined below: Complete Response - Complete disappearance of all known disease for at least 4 weeks; Partial Response - A reduction of at least 50% in the size of all measurable tumor as quantitated by the sum of the products of the largest diameters of measurable lesions when compared with that measurement at the time of study enrollment and maintained for at least 4 weeks.
- groups
- description
- Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
- id
- OG000
- title
- Arm I (Low-dose Lenalidomide)
- description
- Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
- id
- OG001
- title
- Arm II (High-dose Lenalidomide)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only eligible patients are considered in the analysis of this outcome measure
- reporting Status
- POSTED
- time Frame
- 26 cycles of chemotherapy - up to 3 years after enrollment
- title
- Number of Patients Who Demonstrate Complete or Partial Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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