TriangleNCT00478361 · OUTCOME
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Hazard Ratio
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Registration Date of each participant for up to three years or death whichever came first
What was measured
The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome.
Groups in this outcome
Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
| Group | Source count |
|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | 39 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | 0.25 | Not reported | 0.07 | 0.95 | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | 1.09 | Not reported | 0.44 | 2.70 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.07
- upper Limit
- 0.95
- value
- 0.25
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.44
- upper Limit
- 2.70
- value
- 1.09
- title
- Partial Response
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
- id
- OG000
- title
- Gemcitabine, Paclitaxel and Doxorubicin
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Registration Date of each participant for up to three years or death whichever came first
- title
- Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
- type
- SECONDARY
- unit Of Measure
- Hazard Ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice