NCT03132922 · OUTCOME
Duration of Stable Disease (DoSD)
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 date of afamitresgene autoleucel infusion to first date of radiological PD or censored date
What was measured
DoSD was defined as the time from the date of T-cell infusion to the first date of the radiological PD. This analysis of DoSD only applied to participants with BOR as confirmed CR, confirmed PR, or confirmed SD.
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 | 2 |
| Afamitresgene Autoleucel, Group 2 | 3 |
| Afamitresgene Autoleucel, Group 3 + Expansion | 23 |
| 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 | 12.3 | Not reported | NA | NA | Confidence intervals could not be estimated for some arms due to a limited number of events and censoring; therefore, only median duration of stable disease is reported where applicable. |
| Afamitresgene Autoleucel, Group 2 | 12.1 | Not reported | NA | NA | Confidence intervals could not be estimated for some arms due to a limited number of events and censoring; therefore, only median duration of stable disease is reported where applicable. |
| Afamitresgene Autoleucel, Group 3 + Expansion | 20.4 | Not reported | 12.286 | 37.857 | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 25.143 | Not reported | 13.143 | NA | Upper confidence interval bounds were not estimable in some arms due to censoring |
Complete source fields
- classes
- categories
- measurements
- comment
- Confidence intervals could not be estimated for some arms due to a limited number of events and censoring; therefore, only median duration of stable disease is reported where applicable.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 12.3
- comment
- Confidence intervals could not be estimated for some arms due to a limited number of events and censoring; therefore, only median duration of stable disease is reported where applicable.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 12.1
- group Id
- OG002
- lower Limit
- 12.286
- upper Limit
- 37.857
- value
- 20.4
- comment
- Upper confidence interval bounds were not estimable in some arms due to censoring
- group Id
- OG003
- lower Limit
- 13.143
- upper Limit
- NA
- value
- 25.143
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- DoSD was defined as the time from the date of T-cell infusion to the first date of the radiological PD. This analysis of DoSD only applied to participants with BOR as confirmed CR, confirmed PR, or confirmed SD.
- 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 date of afamitresgene autoleucel infusion to first date of radiological PD or censored date
- title
- Duration of Stable Disease (DoSD)
- type
- SECONDARY
- unit Of Measure
- Weeks
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