NCT03132922 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From initial confirmed response (DR or PR) until PD or censored date. is defined as all participants who had not experienced the event of interest (i.e. ongoing, event free) at the time of the data cut off (used for the analysis).
What was measured
DoR was measured from the first CR/PR (whichever was first recorded) until the first date of progressive disease.
Analysis population: No patients in Groups 1 and 2 achieved objective response.
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 | 0 |
| Afamitresgene Autoleucel, Group 2 | 0 |
| Afamitresgene Autoleucel Group 3 + Expansion | 9 |
| Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afamitresgene Autoleucel Group 3 + Expansion | 25.6 | Not reported | 12.286 | NA | Upper confidence interval bounds were not estimable due to censoring |
| Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | NA | Not reported | NA | NA | Median and confidence intervals were not etimable due to censoring |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper confidence interval bounds were not estimable due to censoring
- group Id
- OG002
- lower Limit
- 12.286
- upper Limit
- NA
- value
- 25.6
- comment
- Median and confidence intervals were not etimable due to censoring
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- DoR was measured from the first CR/PR (whichever was first recorded) until the first date of progressive disease.
- 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
- MEAN
- population Description
- No patients in Groups 1 and 2 achieved objective response.
- reporting Status
- POSTED
- time Frame
- From initial confirmed response (DR or PR) until PD or censored date. is defined as all participants who had not experienced the event of interest (i.e. ongoing, event free) at the time of the data cut off (used for the analysis).
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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