NCT03132922 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.
What was measured
PFS was defined as the time from the date of the first T-cell infusion to the first date of the radiological PD or death date (due to any reason), whichever event was earlier.
Analysis population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
Groups in this outcome
Afamitresgene Autoleucel, Group 1
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
Afamitresgene Autoleucel, Group 2
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
Afamitresgene Autoleucel, Group 3 + Expansion
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
| Group | Source count |
|---|---|
| Afamitresgene Autoleucel, Group 1 | 3 |
| Afamitresgene Autoleucel, Group 2 | 3 |
| Afamitresgene Autoleucel, Group 3 + Expansion | 32 |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel, Group 1 | 8.9 | Not reported | 5.571 | 12.286 | Not reported |
| Afamitresgene Autoleucel, Group 2 | 12.1 | Not reported | 10.857 | 12.143 | Not reported |
| Afamitresgene Autoleucel, Group 3 + Expansion | 12.4 | Not reported | 10.000 | 20.429 | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 19.143 | Not reported | 11.571 | NA | Upper confidence interval bounds were not estimable in some arms due to censoring |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.571
- upper Limit
- 12.286
- value
- 8.9
- group Id
- OG001
- lower Limit
- 10.857
- upper Limit
- 12.143
- value
- 12.1
- group Id
- OG002
- lower Limit
- 10.000
- upper Limit
- 20.429
- value
- 12.4
- comment
- Upper confidence interval bounds were not estimable in some arms due to censoring
- group Id
- OG003
- lower Limit
- 11.571
- upper Limit
- NA
- value
- 19.143
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- PFS was defined as the time from the date of the first T-cell infusion to the first date of the radiological PD or death date (due to any reason), whichever event was earlier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
- id
- OG000
- title
- Afamitresgene Autoleucel, Group 1
- description
- Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
- id
- OG001
- title
- Afamitresgene Autoleucel, Group 2
- description
- Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
- id
- OG002
- title
- Afamitresgene Autoleucel, Group 3 + Expansion
- description
- Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
- id
- OG003
- title
- Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- param Type
- MEDIAN
- population Description
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
- reporting Status
- POSTED
- time Frame
- From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice
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