TriangleNCT00113763 · OUTCOME
Progression-free Survival Time (Mutant KRAS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group.
What was measured
Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
Analysis population: Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.
Groups in this outcome
Panitumumab Plus Best Supportive Care
Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
BSC Alone
Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
| Group | Source count |
|---|---|
| Panitumumab Plus Best Supportive Care | 84 |
| BSC Alone | 100 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panitumumab Plus Best Supportive Care | 7.4 | Not reported | 7.3 | 7.9 | Not reported |
| BSC Alone | 7.3 | Not reported | 6.3 | 7.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.3
- upper Limit
- 7.9
- value
- 7.4
- group Id
- OG001
- lower Limit
- 6.3
- upper Limit
- 7.9
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 100
- units
- Participants
- description
- Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
- id
- OG000
- title
- Panitumumab Plus Best Supportive Care
- description
- Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
- id
- OG001
- title
- BSC Alone
- param Type
- MEDIAN
- population Description
- Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group.
- title
- Progression-free Survival Time (Mutant KRAS)
- type
- POST_HOC
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice