TriangleNCT02445248 · OUTCOME
Progression Free Survival (PFS) 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
PFS is the time from date of CTL019 infusion to the date of first documented disease progression 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 a US facility and an EU facility (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 | 3.0 | Not reported | 2.4 | 6.2 | Not reported |
| Tisagenlecleucel - Cohort A | 2.9 | Not reported | 1.0 | NA | NA: The upper limit of the Confidence Interval could ne be reached because there were not enough events to estimate the time to the later events. |
| Tisagenlecleucel - All Patients | 2.9 | Not reported | 2.3 | 5.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.4
- upper Limit
- 6.2
- value
- 3.0
- comment
- NA: The upper limit of the Confidence Interval could ne be reached because there were not enough events to estimate the time to the later events.
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 2.9
- group Id
- OG002
- lower Limit
- 2.3
- upper Limit
- 5.2
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 115
- units
- Participants
- description
- PFS is the time from date of CTL019 infusion to the date of first documented disease progression 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 a US facility and an EU facility (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
- Progression Free Survival (PFS) Per Independent Review Committee
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice