TriangleNCT02086552 · OUTCOME
Complete Response, Assessed Using the International Myeloma Working Group (IMWG) Uniform Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years
What was measured
A comfirmed Complete Response (CR) is defined as a CR noted as the objective status on 2 consecutive evaluations. To be categorized as a CR, patients must exhibit the following:\> * Negative immunofixation of serum and urine c, and\> * Disappearance of any soft tissue plasmacytoma, and\> * \<5% plasma cells in Bone Marrow, and\> * If the only measurable disease is the serum free light chain (FLC), a normal FLC ratio.\> We are reporting the proportion of patients achieving a CR or higher divided by the total number of evaluable patients.\> Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Analysis population: Of the 28 patients registered, one cancelled prior to treatment and 1 was ineligible due to protocol violation. Therefore 26 patients were used in this analysis.
Groups in this outcome
Treatment (Sonidegib, Lenalidomide)
Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Treatment (Sonidegib, Lenalidomide) | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Sonidegib, Lenalidomide) | 0.48 | Not reported | 0.27 | 0.69 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.27
- upper Limit
- 0.69
- value
- 0.48
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- A comfirmed Complete Response (CR) is defined as a CR noted as the objective status on 2 consecutive evaluations. To be categorized as a CR, patients must exhibit the following:\> * Negative immunofixation of serum and urine c, and\> * Disappearance of any soft tissue plasmacytoma, and\> * \<5% plasma cells in Bone Marrow, and\> * If the only measurable disease is the serum free light chain (FLC), a normal FLC ratio.\> We are reporting the proportion of patients achieving a CR or higher divided by the total number of evaluable patients.\> Exact binomial 95% confidence intervals for the true success proportion will be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Treatment (Sonidegib, Lenalidomide)
- param Type
- NUMBER
- population Description
- Of the 28 patients registered, one cancelled prior to treatment and 1 was ineligible due to protocol violation. Therefore 26 patients were used in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Complete Response, Assessed Using the International Myeloma Working Group (IMWG) Uniform Response Criteria
- type
- PRIMARY
- unit Of Measure
- proportion of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice