TriangleNCT00789373 · OUTCOME
Independently-assessed Objective 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
- Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)
What was measured
To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
Analysis population: Randomized participants with reviewable scan--(316/359 \[88%\] Maintenance arm and 156/180 \[87%\] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).
Groups in this outcome
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
Pemetrexed + Cisplatin Followed by Placebo
pemetrexed + cisplatin followed by placebo plus best supportive care
| Group | Source count |
|---|---|
| Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 316 |
| Pemetrexed + Cisplatin Followed by Placebo | 156 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 3.94 | Not reported | 2.96 | 4.24 | Not reported |
| Pemetrexed + Cisplatin Followed by Placebo | 2.60 | Not reported | 2.23 | 2.92 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.96
- upper Limit
- 4.24
- value
- 3.94
- group Id
- OG001
- lower Limit
- 2.23
- upper Limit
- 2.92
- value
- 2.60
- denoms
- counts
- group Id
- OG000
- value
- 316
- group Id
- OG001
- value
- 156
- units
- Participants
- description
- To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
- id
- OG000
- title
- Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
- description
- pemetrexed + cisplatin followed by placebo plus best supportive care
- id
- OG001
- title
- Pemetrexed + Cisplatin Followed by Placebo
- param Type
- MEDIAN
- population Description
- Randomized participants with reviewable scan--(316/359 \[88%\] Maintenance arm and 156/180 \[87%\] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).
- reporting Status
- POSTED
- time Frame
- Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)
- title
- Independently-assessed Objective Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice