NCT02360579 · OUTCOME
Disease Assessment for Disease Control Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
What was measured
Evaluate the efficacy endpoints of disease control rate (DCR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
Analysis population: The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Due to the small number of patients this outcome measure was not analyzed for Cohort 3 per the statistical analysis plan.
Groups in this outcome
Cohort 2
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
Cohort 4
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
Cohort 1
Non-cryopreserved LN-144 (Gen 1 infusion product)
| Group | Source count |
|---|---|
| Cohort 2 | 66 |
| Cohort 4 | 87 |
| Cohort 1 | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2 | 48 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 | 72 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 | 12 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 72
- group Id
- OG002
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 87
- group Id
- OG002
- value
- 20
- units
- Participants
- description
- Evaluate the efficacy endpoints of disease control rate (DCR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
- groups
- description
- Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
- id
- OG000
- title
- Cohort 2
- description
- Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
- id
- OG001
- title
- Cohort 4
- description
- Non-cryopreserved LN-144 (Gen 1 infusion product)
- id
- OG002
- title
- Cohort 1
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Due to the small number of patients this outcome measure was not analyzed for Cohort 3 per the statistical analysis plan.
- reporting Status
- POSTED
- time Frame
- Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
- title
- Disease Assessment for Disease Control Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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