TriangleNCT03364231 · OUTCOME
Time to Treatment Failure (TTF)
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 first dose on Day 1 of Cycle 1 (28 days = 1 cycle) up to discontinuation of treatment (up to approximately 4.2 years)
What was measured
TTF is defined as a composite endpoint measuring time from Cycle 1/Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. PD was assessed based on Revised Response Criteria for non-Hodgkin's lymphoma, Lugano Classification for participants with MZL and consensus-based 6th IWWM for participants with WM. Per Lugano Classification, PD was defined as the appearance of any new lesion more than 1.5 cm in any axis, even if other lesions are decreasing in size. At least a 50% increase from nadir in one of the following: SPD of index lesions, GTD of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node is now ≥ 1.5 cm. Per IWWM criteria PD was defined as more than 25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to the disease.
Analysis population: mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment.
Groups in this outcome
MZL: Umbralisib
Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
WM: Umbralisib
Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
| Group | Source count |
|---|---|
| MZL: Umbralisib | 8 |
| WM: Umbralisib | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MZL: Umbralisib | 13.1 | Not reported | 1.4 | NA | Upper limit of 95% CI was not evaluable due to an insufficient number of participants with events. |
| WM: Umbralisib | 6.5 | Not reported | 2.1 | 15.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 13.1
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 15.9
- value
- 6.5
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- TTF is defined as a composite endpoint measuring time from Cycle 1/Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. PD was assessed based on Revised Response Criteria for non-Hodgkin's lymphoma, Lugano Classification for participants with MZL and consensus-based 6th IWWM for participants with WM. Per Lugano Classification, PD was defined as the appearance of any new lesion more than 1.5 cm in any axis, even if other lesions are decreasing in size. At least a 50% increase from nadir in one of the following: SPD of index lesions, GTD of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node is now ≥ 1.5 cm. Per IWWM criteria PD was defined as more than 25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to the disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
- id
- OG000
- title
- MZL: Umbralisib
- description
- Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
- id
- OG001
- title
- WM: Umbralisib
- param Type
- MEDIAN
- population Description
- mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment.
- reporting Status
- POSTED
- time Frame
- From first dose on Day 1 of Cycle 1 (28 days = 1 cycle) up to discontinuation of treatment (up to approximately 4.2 years)
- title
- Time to Treatment Failure (TTF)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice