TriangleNCT02492711 · OUTCOME
To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Analysis population: Analysis population consisted of all patient who had investigator-assessed responses to treatment as of the interim analysis. The outcome measure is calculated only for the randomized study population. The 88 participants in the sub-study were not part of the efficacy population.
Groups in this outcome
Margetuximab Plus Chemotherapy
Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
Trastuzumab Plus Chemotherapy
Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
Margetuximab Infusion Substudy
Margetuximab with or without chemotherapy
| Group | Source count |
|---|---|
| Margetuximab Plus Chemotherapy | 160 |
| Trastuzumab Plus Chemotherapy | 177 |
| Margetuximab Infusion Substudy | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Margetuximab Plus Chemotherapy | 5.6 | Not reported | 5.06 | 6.67 | Not reported |
| Trastuzumab Plus Chemotherapy | 4.2 | Not reported | 3.98 | 5.39 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.556
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.870
- estimate Comment
- Stratified Cox Proportional Model
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0014
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Comment
- Stratified Log-Rank Test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.556
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.870
- estimate Comment
- Stratified Cox Proportional Model
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0014
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Comment
- Stratified Log-Rank Test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.06
- upper Limit
- 6.67
- value
- 5.6
- group Id
- OG001
- lower Limit
- 3.98
- upper Limit
- 5.39
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 177
- group Id
- OG002
- value
- 0
- units
- Participants
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
- id
- OG000
- title
- Margetuximab Plus Chemotherapy
- description
- Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
- id
- OG001
- title
- Trastuzumab Plus Chemotherapy
- description
- Margetuximab with or without chemotherapy
- id
- OG002
- title
- Margetuximab Infusion Substudy
- param Type
- MEDIAN
- population Description
- Analysis population consisted of all patient who had investigator-assessed responses to treatment as of the interim analysis. The outcome measure is calculated only for the randomized study population. The 88 participants in the sub-study were not part of the efficacy population.
- reporting Status
- POSTED
- time Frame
- Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
- title
- To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice