TriangleNCT04042376 · OUTCOME
Progression Free Survival (PFS)
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 day of first dose (Day 1) until PD or death (up to 49.3 months)
What was measured
PFS was defined as duration from the date of first dose to the date of disease progression or death, whichever occurs first, assessed according to the modified sixth IWWM (NCCN 2019) criteria. PD (at least 1 of the following): \>=25% IgM increase in serum IgM with \>=500 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 cm, \>=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node \>1 cm 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: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
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 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib 420 mg | 23.95 | Not reported | 14.69 | 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
- 14.69
- upper Limit
- NA
- value
- 23.95
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- PFS was defined as duration from the date of first dose to the date of disease progression or death, whichever occurs first, assessed according to the modified sixth IWWM (NCCN 2019) criteria. PD (at least 1 of the following): \>=25% IgM increase in serum IgM with \>=500 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 cm, \>=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node \>1 cm 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
- All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From day of first dose (Day 1) until PD or death (up to 49.3 months)
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice