TriangleNCT00142116 · OUTCOME
Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 3 years
What was measured
Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).
Analysis population: Intent-to-treat basis
Groups in this outcome
All WM Patients
Waldenstrom's Macroglobulinemia Patients
| Group | Source count |
|---|---|
| All WM Patients | 25 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All WM Patients | 1 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All WM Patients | 15 | Not reported | Not reported | Not reported | Not reported |
Minor Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All WM Patients | 2 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All WM Patients | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 15
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Minor Response
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- Stable Disease
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).
- groups
- description
- Waldenstrom's Macroglobulinemia Patients
- id
- OG000
- title
- All WM Patients
- param Type
- NUMBER
- population Description
- Intent-to-treat basis
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- Objective Response Rate
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice