TriangleNCT00540644 · OUTCOME
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
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 6 cycles
What was measured
Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
Analysis population: All patients receiving at least one dose of study drug and having at least one post-baseline visit
Groups in this outcome
Original Study - Revlimid, Cyclophosphamide, Prednisone
Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Extension - Revlimid, Cyclophosphamide, Prednisone
Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
| Group | Source count |
|---|---|
| Original Study - Revlimid, Cyclophosphamide, Prednisone | 45 |
| Extension - Revlimid, Cyclophosphamide, Prednisone | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Original Study - Revlimid, Cyclophosphamide, Prednisone | 86.7 | Not reported | 73.2 | 95.0 | Not reported |
| Extension - Revlimid, Cyclophosphamide, Prednisone | 71.4 | Not reported | 47.8 | 88.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.2
- upper Limit
- 95.0
- value
- 86.7
- group Id
- OG001
- lower Limit
- 47.8
- upper Limit
- 88.7
- value
- 71.4
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
- id
- OG000
- title
- Original Study - Revlimid, Cyclophosphamide, Prednisone
- description
- Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
- id
- OG001
- title
- Extension - Revlimid, Cyclophosphamide, Prednisone
- param Type
- NUMBER
- population Description
- All patients receiving at least one dose of study drug and having at least one post-baseline visit
- reporting Status
- POSTED
- time Frame
- After 6 cycles
- title
- Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice