NCT03132922 · OUTCOME
Overall Survival (OS)
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 death due to any reason or censored date From afamitresgene autoleucel infusion until death due to any reason or censored date
What was measured
OS was defined as the time from the date of afamitresgene autoleucel infusion to the date of death (due to any reason).
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
Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
| Group | Source count |
|---|---|
| Afamitresgene Autoleucel, Group 1 | 3 |
| Afamitresgene Autoleucel, Group 2 | 3 |
| Afamitresgene Autoleucel Group 3 + Expansion | 32 |
| Substudy: 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 | 19.8 | Not reported | 18.857 | 20.714 | Not reported |
| Afamitresgene Autoleucel, Group 2 | NA | Not reported | NA | NA | Median overall survival was not reached in some arms at the time of data cutoff due to ongoing survival; therefore, median OS and associated confidence intervals are not reported for those arms. |
| Afamitresgene Autoleucel Group 3 + Expansion | 42.9 | Not reported | 25.429 | NA | Upper confidence interval bounds were not estimable in some arms due to censoring |
| Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | NA | Not reported | 11.571 | NA | Median overall survival was not reached in some arms at the time of data cutoff due to ongoing survival; therefore, median OS and associated confidence intervals are not reported for those arms. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.857
- upper Limit
- 20.714
- value
- 19.8
- comment
- Median overall survival was not reached in some arms at the time of data cutoff due to ongoing survival; therefore, median OS and associated confidence intervals are not reported for those arms.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper confidence interval bounds were not estimable in some arms due to censoring
- group Id
- OG002
- lower Limit
- 25.429
- upper Limit
- NA
- value
- 42.9
- comment
- Median overall survival was not reached in some arms at the time of data cutoff due to ongoing survival; therefore, median OS and associated confidence intervals are not reported for those arms.
- group Id
- OG003
- lower Limit
- 11.571
- upper Limit
- NA
- value
- NA
- 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
- OS was defined as the time from the date of afamitresgene autoleucel infusion to the date of death (due to any reason).
- 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 (1.2-10x10\^9 transduced cells).
- id
- OG003
- title
- Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From afamitresgene autoleucel infusion until death due to any reason or censored date From afamitresgene autoleucel infusion until death due to any reason or censored date
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Weeks
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