TriangleNCT02445248 · OUTCOME
Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Cohort A & in All Patients
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
- 5 years
What was measured
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first.
Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
Groups in this outcome
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 - Cohort A | 16 |
| Tisagenlecleucel - All Patients | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tisagenlecleucel - Cohort A | 43.8 | Not reported | 19.8 | 70.1 | Not reported |
| Tisagenlecleucel - All Patients | 53.0 | Not reported | 43.5 | 62.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.8
- upper Limit
- 70.1
- value
- 43.8
- group Id
- OG001
- lower Limit
- 43.5
- upper Limit
- 62.4
- value
- 53.0
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first.
- 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 Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
- id
- OG000
- 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
- OG001
- title
- Tisagenlecleucel - All Patients
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Cohort A & in All Patients
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice