TriangleNCT01170663 · OUTCOME
Percentage of Participants With CR or PR (Objective 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
- Randomization up to 22.2 months
What was measured
ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)\*100.
Analysis population: All participants according to the treatment group to which they were randomized.
Groups in this outcome
Ramucirumab (IMC-1211B) Plus Paclitaxel
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo Plus Paclitaxel
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
| Group | Source count |
|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 330 |
| Placebo Plus Paclitaxel | 335 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 27.9 | Not reported | 23.3 | 33.0 | Not reported |
| Placebo Plus Paclitaxel | 16.1 | Not reported | 12.6 | 20.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.16
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.14
- statistical Comment
- Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.16
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.14
- statistical Comment
- Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.3
- upper Limit
- 33.0
- value
- 27.9
- group Id
- OG001
- lower Limit
- 12.6
- upper Limit
- 20.4
- value
- 16.1
- denoms
- counts
- group Id
- OG000
- value
- 330
- group Id
- OG001
- value
- 335
- units
- Participants
- description
- ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)\*100.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
- id
- OG000
- title
- Ramucirumab (IMC-1211B) Plus Paclitaxel
- description
- Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
- id
- OG001
- title
- Placebo Plus Paclitaxel
- param Type
- NUMBER
- population Description
- All participants according to the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Randomization up to 22.2 months
- title
- Percentage of Participants With CR or PR (Objective Response Rate [ORR])
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice