NCT03568461 · OUTCOME
Tisagenlecleucel Transgene Concentration Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) Method, by Clinical Response Per IRC Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- copies/ug DNA
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Month 60 (peripheral blood), Month 6 (bone marrow)
What was measured
This is the summary of cellular kinetic concentrations for tisagenlecleucel (CTL019) transgene levels in peripheral blood and bone marrow following infusion.
Analysis population: Participants in the Cellular kinetic set (CKAS) with an available value for the outcome measure. The CKAS consisted of patients in the Efficacy analysis set who provided an evaluable cellular kinetic profile (at least 1 cellular kinetic parameter).
Groups in this outcome
CTL019
All participants who were enrolled in the study
| Group | Source count |
|---|---|
| CTL019 | 22 |
Reported measurements
Peripheral blood
| Group | Source count |
|---|---|
| CTL019 | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CTL019 | 202 | 126 | Not reported | Not reported | Not reported |
Bone marrow
| Group | Source count |
|---|---|
| CTL019 | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CTL019 | 317 | 3.17 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 126
- value
- 202
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- title
- Peripheral blood
- categories
- measurements
- group Id
- OG000
- spread
- 3.17
- value
- 317
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- title
- Bone marrow
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- description
- This is the summary of cellular kinetic concentrations for tisagenlecleucel (CTL019) transgene levels in peripheral blood and bone marrow following infusion.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- All participants who were enrolled in the study
- id
- OG000
- title
- CTL019
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants in the Cellular kinetic set (CKAS) with an available value for the outcome measure. The CKAS consisted of patients in the Efficacy analysis set who provided an evaluable cellular kinetic profile (at least 1 cellular kinetic parameter).
- reporting Status
- POSTED
- time Frame
- Month 60 (peripheral blood), Month 6 (bone marrow)
- title
- Tisagenlecleucel Transgene Concentration Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) Method, by Clinical Response Per IRC Assessment
- type
- SECONDARY
- unit Of Measure
- copies/ug DNA
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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