NCT02860286 · OUTCOME
Part 1 and 2: To Evaluate the Duration of Response (DOR) in Subjects With Confirmed CR or PR
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
- Every 6 weeks up to disease progression or start of new anti-cancer therapy assessed for up to 12 months
What was measured
DOR was calculated for subjects with a confirmed CR or PR. DOR is defined as the time from the date of the initial response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first. DOR censoring rules followed those of the PFS analysis defined in the SAP. DOR was analyzed using the Kaplan-Meier methods and the median DOR, first quartile, and third quartile was presented. The associated 2- sided 95% CIs was estimated.
Groups in this outcome
Part 1
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 statu
Part 2
Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
| Group | Source count |
|---|---|
| Part 1 | 13 |
| Part 2 | 61 |
Reported measurements
DOR great than 6 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
DOR great than 12 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
DOR great than 18 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- DOR great than 6 weeks
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- DOR great than 12 weeks
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- DOR great than 18 weeks
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- DOR was calculated for subjects with a confirmed CR or PR. DOR is defined as the time from the date of the initial response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first. DOR censoring rules followed those of the PFS analysis defined in the SAP. DOR was analyzed using the Kaplan-Meier methods and the median DOR, first quartile, and third quartile was presented. The associated 2- sided 95% CIs was estimated.
- groups
- description
- Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 statu
- id
- OG000
- title
- Part 1
- description
- Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
- id
- OG001
- title
- Part 2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Every 6 weeks up to disease progression or start of new anti-cancer therapy assessed for up to 12 months
- title
- Part 1 and 2: To Evaluate the Duration of Response (DOR) in Subjects With Confirmed CR or PR
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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