NCT02004275 · OUTCOME
Disease Control Rate (DCR), Defined as Stable Disease (SD) and Better According to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of partcipants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 42 days
What was measured
Proportion of patients that went two of more cycles of treatment without discontinuing treatment for progression or intolerability.
Groups in this outcome
Phase II Arm I (Pomalidomide, Dexamethasone)
Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)
Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase II Arm I (Pomalidomide, Dexamethasone) | 39 |
| Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib) | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Arm I (Pomalidomide, Dexamethasone) | .949 | Not reported | .827 | .994 | Not reported |
| Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib) | .921 | Not reported | .786 | .983 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- .827
- upper Limit
- .994
- value
- .949
- group Id
- OG001
- lower Limit
- .786
- upper Limit
- .983
- value
- .921
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Proportion of patients that went two of more cycles of treatment without discontinuing treatment for progression or intolerability.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
- id
- OG000
- title
- Phase II Arm I (Pomalidomide, Dexamethasone)
- description
- Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 42 days
- title
- Disease Control Rate (DCR), Defined as Stable Disease (SD) and Better According to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
- type
- SECONDARY
- unit Of Measure
- proportion of partcipants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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