TriangleNCT03846427 · OUTCOME
DOR Event-Free Rate by IRC Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
What was measured
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Analysis population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
Groups in this outcome
Zanubrutinib
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
| Group | Source count |
|---|---|
| Zanubrutinib | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 72.9 | Not reported | 54.4 | 84.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.4
- upper Limit
- 84.9
- value
- 72.9
- denoms
- counts
- group Id
- OG000
- value
- 45
- units
- Participants
- description
- DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
- id
- OG000
- title
- Zanubrutinib
- param Type
- NUMBER
- population Description
- Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
- reporting Status
- POSTED
- time Frame
- Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
- title
- DOR Event-Free Rate by IRC Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice