TriangleNCT02492711 · OUTCOME
Infusion Rate Sub-study All Safety
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Throughout the study, average duration 6 months
What was measured
Incidence of all grades of infusion-related reactions
Analysis population: Only patients in the infusion substudy were evaluated for this outcome measure
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 Stage A1
Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 60 minute infusion in Cycle 2.
Margetuximab Stage A2
Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
Margetuximab Stage B
Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
| Group | Source count |
|---|---|
| Margetuximab Plus Chemotherapy | 0 |
| Trastuzumab Plus Chemotherapy | 0 |
| Margetuximab Stage A1 | 8 |
| Margetuximab Stage A2 | 9 |
| Margetuximab Stage B | 71 |
Reported measurements
Infusion related reaction Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Margetuximab Stage A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Margetuximab Stage A2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Margetuximab Stage B | 16 | Not reported | Not reported | Not reported | Not reported |
Infusion related reaction Cycle 2 or higher
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Margetuximab Stage A1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Margetuximab Stage A2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Margetuximab Stage B | 2 | Not reported | Not reported | Not reported | Not reported |
No infusion related reaction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Margetuximab Stage A1 | 7 | Not reported | Not reported | Not reported | Not reported |
| Margetuximab Stage A2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Margetuximab Stage B | 55 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 16
- title
- Infusion related reaction Cycle 1
- categories
- measurements
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- title
- Infusion related reaction Cycle 2 or higher
- categories
- measurements
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 55
- title
- No infusion related reaction
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 71
- units
- Participants
- description
- Incidence of all grades of infusion-related reactions
- 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 administered as a 120 minute first infusion in Cycle 1 followed by 60 minute infusion in Cycle 2.
- id
- OG002
- title
- Margetuximab Stage A1
- description
- Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
- id
- OG003
- title
- Margetuximab Stage A2
- description
- Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
- id
- OG004
- title
- Margetuximab Stage B
- param Type
- NUMBER
- population Description
- Only patients in the infusion substudy were evaluated for this outcome measure
- reporting Status
- POSTED
- time Frame
- Throughout the study, average duration 6 months
- title
- Infusion Rate Sub-study All Safety
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice