TriangleNCT00844649 · OUTCOME
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
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
- Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
What was measured
Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Analysis population: Intent to Treat population (ITT population) consisted of all randomized participants.
Groups in this outcome
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
Gemcitabine
Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
| Group | Source count |
|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 431 |
| Gemcitabine | 430 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | 23 | Not reported | 19.1 | 27.2 | Not reported |
| Gemcitabine | 7 | Not reported | 5.0 | 10.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.178
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.662
- estimate Comment
- Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone
- group Description
- PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Response Rate Ratio
- param Value
- 3.19
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 2.178
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.662
- estimate Comment
- Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone
- group Description
- PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Response Rate Ratio
- param Value
- 3.19
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.1
- upper Limit
- 27.2
- value
- 23
- group Id
- OG001
- lower Limit
- 5.0
- upper Limit
- 10.1
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 431
- group Id
- OG001
- value
- 430
- units
- Participants
- description
- Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
- id
- OG000
- title
- Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
- description
- Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
- id
- OG001
- title
- Gemcitabine
- param Type
- NUMBER
- population Description
- Intent to Treat population (ITT population) consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
- title
- Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice