NCT02858310 · OUTCOME
Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years
What was measured
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Analysis population: Participants in Phase II only were evaluable for this outcome.
Groups in this outcome
Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
| Group | Source count |
|---|---|
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 18 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Partial Response
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
- groups
- description
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- id
- OG000
- title
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants in Phase II only were evaluable for this outcome.
- reporting Status
- POSTED
- time Frame
- At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years
- title
- Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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