TriangleNCT02445248 · OUTCOME
Duration of Overall Response (DOR) Per IRC
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 approx. 60.1 months
What was measured
DOR is the time from achievement of CR or PR, whichever occurs first, to relapse or death due to diffuse large B-cell lymphoma (DLBCL).
Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel and who achieved a completer response (CR) or a partial response (PR).
Groups in this outcome
Tisagenlecleucel - Main Cohort
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
Tisagenlecleucel - Cohort A
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
Tisagenlecleucel - All Patients
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
| Group | Source count |
|---|---|
| Tisagenlecleucel - Main Cohort | 54 |
| Tisagenlecleucel - Cohort A | 7 |
| Tisagenlecleucel - All Patients | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tisagenlecleucel - Main Cohort | NA | Not reported | 10.0 | NA | NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event |
| Tisagenlecleucel - Cohort A | NA | Not reported | 1.2 | NA | NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event |
| Tisagenlecleucel - All Patients | NA | Not reported | 10.0 | NA | NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event |
Complete source fields
- classes
- categories
- measurements
- comment
- NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event
- group Id
- OG000
- lower Limit
- 10.0
- upper Limit
- NA
- value
- NA
- comment
- NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- NA
- value
- NA
- comment
- NA: The Median and the upper limit of Confidence Interval could not be reached because fewer than half of the patients experienced an event
- group Id
- OG002
- lower Limit
- 10.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 61
- units
- Participants
- description
- DOR is the time from achievement of CR or PR, whichever occurs first, to relapse or death due to diffuse large B-cell lymphoma (DLBCL).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
- id
- OG000
- title
- Tisagenlecleucel - Main Cohort
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
- id
- OG001
- title
- Tisagenlecleucel - Cohort A
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
- id
- OG002
- title
- Tisagenlecleucel - All Patients
- param Type
- MEDIAN
- population Description
- Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel and who achieved a completer response (CR) or a partial response (PR).
- reporting Status
- POSTED
- time Frame
- up to approx. 60.1 months
- title
- Duration of Overall Response (DOR) Per IRC
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice