NCT02489903 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed up to 49 months
What was measured
Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.
Groups in this outcome
RRx-001 + Platinum Doublet (A01-09)
4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
RRx-001 + Platinum + RRx-001 (A10)
RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
Investigator's Choice (A10)
Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
| Group | Source count |
|---|---|
| RRx-001 + Platinum Doublet (A01-09) | 89 |
| RRx-001 + Platinum + RRx-001 (A10) | 10 |
| Investigator's Choice (A10) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRx-001 + Platinum Doublet (A01-09) | 5.87 | Not reported | 4.46 | 7.54 | Not reported |
| RRx-001 + Platinum + RRx-001 (A10) | 6.50 | Not reported | NA | NA | insufficient number of participants with events |
| Investigator's Choice (A10) | 12 | Not reported | NA | NA | insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.46
- upper Limit
- 7.54
- value
- 5.87
- comment
- insufficient number of participants with events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.50
- comment
- insufficient number of participants with events
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 2
- units
- Participants
- description
- Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
- id
- OG000
- title
- RRx-001 + Platinum Doublet (A01-09)
- description
- RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
- id
- OG001
- title
- RRx-001 + Platinum + RRx-001 (A10)
- description
- Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
- id
- OG002
- title
- Investigator's Choice (A10)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Assessed up to 49 months
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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