TriangleNCT01170663 · OUTCOME
Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
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
- Not reported
- Time frame
- Randomization up to 22.2 months
What was measured
BOR was defined as the best response across all time points from randomization until radiologically confirmed PD 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. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
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
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 0.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | 0.3 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 27.3 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | 15.8 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 52.1 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | 47.5 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 13.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | 24.8 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 0.3 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | 0.9 | Not reported | Not reported | Not reported | Not reported |
No Tumor Response Evaluation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1211B) Plus Paclitaxel | 6.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo Plus Paclitaxel | 10.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- group Id
- OG001
- value
- 0.3
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 27.3
- group Id
- OG001
- value
- 15.8
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 52.1
- group Id
- OG001
- value
- 47.5
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 13.0
- group Id
- OG001
- value
- 24.8
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 0.3
- group Id
- OG001
- value
- 0.9
- title
- Not Evaluable
- categories
- measurements
- group Id
- OG000
- value
- 6.7
- group Id
- OG001
- value
- 10.7
- title
- No Tumor Response Evaluation
- denoms
- counts
- group Id
- OG000
- value
- 330
- group Id
- OG001
- value
- 335
- units
- Participants
- description
- BOR was defined as the best response across all time points from randomization until radiologically confirmed PD 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. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
- 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
- Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice