TriangleNCT04062448 · OUTCOME
Progression Free Survival (PFS) Assessed by Independent Review Committee
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 initial dose up to 3 years and 5 months
What was measured
PFS was defined as duration from the date of initial dose of ibrutinib to the date of first documented evidence of disease progression or death, whichever occurred first regardless of the use of subsequent antineoplastic therapy prior to documented disease progression or death. Kaplan-Meier method was used for the analysis.
Analysis population: All treated analysis set included all enrolled participants who received at least 1 dose of ibrutinib.
Groups in this outcome
Ibrutinib + Rituximab
Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
| Group | Source count |
|---|---|
| Ibrutinib + Rituximab | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib + Rituximab | NA | Not reported | NA | NA | The median and 95% confidence interval were not estimable due to very less number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and 95% confidence interval were not estimable due to very less number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- PFS was defined as duration from the date of initial dose of ibrutinib to the date of first documented evidence of disease progression or death, whichever occurred first regardless of the use of subsequent antineoplastic therapy prior to documented disease progression or death. Kaplan-Meier method was used for the analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
- id
- OG000
- title
- Ibrutinib + Rituximab
- param Type
- MEDIAN
- population Description
- All treated analysis set included all enrolled participants who received at least 1 dose of ibrutinib.
- reporting Status
- POSTED
- time Frame
- From the date of initial dose up to 3 years and 5 months
- title
- Progression Free Survival (PFS) Assessed by Independent Review Committee
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice