TriangleNCT00981058 · 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
- Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
What was measured
PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
Analysis population: All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131
Groups in this outcome
Necitumumab + Gemcitabine + Cisplatin
Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
Gemcitabine + Cisplatin
Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
| Group | Source count |
|---|---|
| Necitumumab + Gemcitabine + Cisplatin | 545 |
| Gemcitabine + Cisplatin | 548 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Necitumumab + Gemcitabine + Cisplatin | 5.7 | Not reported | 5.6 | 6.0 | Not reported |
| Gemcitabine + Cisplatin | 5.5 | Not reported | 4.8 | 5.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.743
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.975
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0201
- param Type
- Hazard Ratio (HR)
- param Value
- 0.851
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.743
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.975
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0201
- param Type
- Hazard Ratio (HR)
- param Value
- 0.851
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 6.0
- value
- 5.7
- group Id
- OG001
- lower Limit
- 4.8
- upper Limit
- 5.6
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 545
- group Id
- OG001
- value
- 548
- units
- Participants
- description
- PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
- id
- OG000
- title
- Necitumumab + Gemcitabine + Cisplatin
- description
- Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
- id
- OG001
- title
- Gemcitabine + Cisplatin
- param Type
- MEDIAN
- population Description
- All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131
- reporting Status
- POSTED
- time Frame
- Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
- title
- Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice