NCT03132922 · OUTCOME
Time to Response (TTR)
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 confirmed CR or PR
What was measured
TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.
Analysis population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel achieving CR or PR.
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 | 0 |
| Afamitresgene Autoleucel, Group 2 | 0 |
| Afamitresgene Autoleucel, Group 3 + Expansion | 9 |
| 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 | 6.4 | Not reported | 6.143 | 24.143 | Not reported |
| Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel | NA | Not reported | NA | NA | Only one participant in this arm achieved a response. With a single observation event, a median time to response and confidence interval cannot be estimated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 6.143
- upper Limit
- 24.143
- value
- 6.4
- comment
- Only one participant in this arm achieved a response. With a single observation event, a median time to response and confidence interval cannot be estimated.
- 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
- TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.
- 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 achieving CR or PR.
- reporting Status
- POSTED
- time Frame
- From afamitresgene autoleucel infusion until first documented confirmed CR or PR
- title
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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