TriangleNCT00102804 · OUTCOME
Progression-Free Survival (PFS) Time
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 PD or death from any cause (up to 41 months)
What was measured
PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Analysis population: Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.
Groups in this outcome
Pemetrexed and BSC
Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
Placebo and BSC
Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
| Group | Source count |
|---|---|
| Pemetrexed and BSC | 441 |
| Placebo and BSC | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pemetrexed and BSC | 4.27 | Not reported | 4.07 | 4.73 | Not reported |
| Placebo and BSC | 2.60 | Not reported | 1.68 | 2.83 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.07
- upper Limit
- 4.73
- value
- 4.27
- group Id
- OG001
- lower Limit
- 1.68
- upper Limit
- 2.83
- value
- 2.60
- denoms
- counts
- group Id
- OG000
- value
- 441
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- id
- OG000
- title
- Pemetrexed and BSC
- description
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- id
- OG001
- title
- Placebo and BSC
- param Type
- MEDIAN
- population Description
- Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.
- reporting Status
- POSTED
- time Frame
- Randomization to measured PD or death from any cause (up to 41 months)
- title
- Progression-Free Survival (PFS) Time
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice