TriangleNCT00102804 · OUTCOME
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to measured PD (up to 41 months)
What was measured
Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\*100.
Analysis population: Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.
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 | 6.8 | Not reported | 5 | 10 | Not reported |
| Placebo and BSC | 1.8 | Not reported | 0 | 5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 10
- value
- 6.8
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 5
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 441
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\*100.
- 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
- NUMBER
- population Description
- Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Baseline to measured PD (up to 41 months)
- title
- Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice