TriangleNCT01631552 · OUTCOME
Objective Response Rate (ORR) by Independent Central Review (ICR)
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
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
What was measured
ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
Analysis population: Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg.
Groups in this outcome
TNBC Target Population
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
| Group | Source count |
|---|---|
| TNBC Target Population | 108 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TNBC Target Population | 34.3 | Not reported | 25.4 | 44.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.4
- upper Limit
- 44.0
- value
- 34.3
- denoms
- counts
- group Id
- OG000
- value
- 108
- units
- Participants
- description
- ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
- id
- OG000
- title
- TNBC Target Population
- param Type
- NUMBER
- population Description
- Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg.
- reporting Status
- POSTED
- time Frame
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
- title
- Objective Response Rate (ORR) by Independent Central Review (ICR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice