TriangleNCT02445248 · OUTCOME
Event Free Survival (EFS) Per 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
- up to approx. 61 months
What was measured
EFS is the time from date of CTL019 infusion to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
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 | 99 |
| Tisagenlecleucel - Cohort A | 16 |
| Tisagenlecleucel - All Patients | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tisagenlecleucel - Main Cohort | 2.8 | Not reported | 2.2 | 3.5 | Not reported |
| Tisagenlecleucel - Cohort A | 2.1 | Not reported | 1.0 | 3.1 | Not reported |
| Tisagenlecleucel - All Patients | 2.8 | Not reported | 2.1 | 3.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.2
- upper Limit
- 3.5
- value
- 2.8
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 3.1
- value
- 2.1
- group Id
- OG002
- lower Limit
- 2.1
- upper Limit
- 3.1
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 115
- units
- Participants
- description
- EFS is the time from date of CTL019 infusion to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
- 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.
- reporting Status
- POSTED
- time Frame
- up to approx. 61 months
- title
- Event Free Survival (EFS) Per Independent Review Committee
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice