TriangleNCT04083235 · OUTCOME
Overall Response Rate (ORR)
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
- Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)
What was measured
The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.
Analysis population: The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.
Groups in this outcome
NALIRIFOX
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Nab-paclitaxel+Gemcitabine
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
| Group | Source count |
|---|---|
| NALIRIFOX | 383 |
| Nab-paclitaxel+Gemcitabine | 387 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NALIRIFOX | 41.8 | Not reported | 36.8 | 46.9 | Not reported |
| Nab-paclitaxel+Gemcitabine | 36.2 | Not reported | 31.4 | 41.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.95
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.69
- estimate Comment
- OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.11
- param Type
- Odds Ratio (OR)
- param Value
- 1.26
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.95
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.69
- estimate Comment
- OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.11
- param Type
- Odds Ratio (OR)
- param Value
- 1.26
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.8
- upper Limit
- 46.9
- value
- 41.8
- group Id
- OG001
- lower Limit
- 31.4
- upper Limit
- 41.2
- value
- 36.2
- denoms
- counts
- group Id
- OG000
- value
- 383
- group Id
- OG001
- value
- 387
- units
- Participants
- description
- The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
- id
- OG000
- title
- NALIRIFOX
- description
- Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
- id
- OG001
- title
- Nab-paclitaxel+Gemcitabine
- param Type
- NUMBER
- population Description
- The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.
- reporting Status
- POSTED
- time Frame
- Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice