TriangleNCT04042376 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of first documented response up to date of first documented PD or death (Day 1 up to 49.3 months)
What was measured
DOR: duration from date of initial documentation of response (PR/better) to date of first documented progressive disease(PD), death or date of censoring if applicable, for responders (PR/better), as assessed by investigator. VGPR/PR: \>=90% reduction or normal serum IgM values (for VGPR) and \>=50% (for PR) reduction of serum IgM, with reduction in lymphadenopathy/splenomegaly if present at baseline. PD(at least 1): \>=25% IgM increase in serum IgM with \>=500 milligrams per deciliters(mg/dL) increase from nadir(lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes \>1.5 centimeters(cm), \>=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node \>1cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease(pleural effusion/Bing Neel syndrome/amyloidosis/light chain deposition/paraprotein mediated disorder).
Analysis population: Analysis population included responders in all treated analysis set who achieved PR or better.
Groups in this outcome
Ibrutinib 420 mg
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
| Group | Source count |
|---|---|
| Ibrutinib 420 mg | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib 420 mg | 20.27 | Not reported | 11.07 | NA | Here, 'NA' signifies that upper limit of 95% confidence interval could not be estimated due to less number of participants with event. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, 'NA' signifies that upper limit of 95% confidence interval could not be estimated due to less number of participants with event.
- group Id
- OG000
- lower Limit
- 11.07
- upper Limit
- NA
- value
- 20.27
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- DOR: duration from date of initial documentation of response (PR/better) to date of first documented progressive disease(PD), death or date of censoring if applicable, for responders (PR/better), as assessed by investigator. VGPR/PR: \>=90% reduction or normal serum IgM values (for VGPR) and \>=50% (for PR) reduction of serum IgM, with reduction in lymphadenopathy/splenomegaly if present at baseline. PD(at least 1): \>=25% IgM increase in serum IgM with \>=500 milligrams per deciliters(mg/dL) increase from nadir(lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes \>1.5 centimeters(cm), \>=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node \>1cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease(pleural effusion/Bing Neel syndrome/amyloidosis/light chain deposition/paraprotein mediated disorder).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
- id
- OG000
- title
- Ibrutinib 420 mg
- param Type
- MEDIAN
- population Description
- Analysis population included responders in all treated analysis set who achieved PR or better.
- reporting Status
- POSTED
- time Frame
- From the date of first documented response up to date of first documented PD or death (Day 1 up to 49.3 months)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice