TriangleNCT03493451 · 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
- Up to approximately 3 years and 1 week
What was measured
DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
Analysis population: Safety analysis set includes all participants who received at least one dose of study drug; Duration of response was summarized for responders (participants who achieved a partial or complete response).
Groups in this outcome
Cohort 1: ENKTL
Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Cohort 2: PTCL-NOS, AITL, and ALCL
Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Cohort 3: MF and SS
Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
| Group | Source count |
|---|---|
| Cohort 1: ENKTL | 7 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | 9 |
| Cohort 3: MF and SS | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: ENKTL | NA | Not reported | 2.66 | NA | Not estimable due to insufficient number of participants with events (progressive disease or death) |
| Cohort 2: PTCL-NOS, AITL, and ALCL | 8.2 | Not reported | 2.50 | NA | Not estimable due to insufficient number of participants with events (progressive disease or death) |
| Cohort 3: MF and SS | 11.3 | Not reported | 2.76 | 11.30 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events (progressive disease or death)
- group Id
- OG000
- lower Limit
- 2.66
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to insufficient number of participants with events (progressive disease or death)
- group Id
- OG001
- lower Limit
- 2.50
- upper Limit
- NA
- value
- 8.2
- group Id
- OG002
- lower Limit
- 2.76
- upper Limit
- 11.30
- value
- 11.3
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG000
- title
- Cohort 1: ENKTL
- description
- Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG001
- title
- Cohort 2: PTCL-NOS, AITL, and ALCL
- description
- Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG002
- title
- Cohort 3: MF and SS
- param Type
- MEDIAN
- population Description
- Safety analysis set includes all participants who received at least one dose of study drug; Duration of response was summarized for responders (participants who achieved a partial or complete response).
- reporting Status
- POSTED
- time Frame
- Up to approximately 3 years and 1 week
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice