TriangleNCT03576131 · OUTCOME
Duration of Response (DoR) According to RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- From Day 1 through 8.8 months (corresponding to maximum observed duration)
What was measured
The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.
Analysis population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
Groups in this outcome
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
| Group | Source count |
|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- units
- Participants
- description
- The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.
- groups
- description
- Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
- id
- OG000
- title
- Biweekly Regimen (GEN1029 0.1 mg/kg)
- description
- Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG001
- title
- Biweekly Regimen (GEN1029 0.2 mg/kg)
- description
- Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG002
- title
- Biweekly Regimen (GEN1029 0.3 mg/kg)
- description
- Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG003
- title
- Biweekly Regimen (GEN1029 1.0 mg/kg)
- description
- Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG004
- title
- Biweekly Regimen (GEN1029 2.0 mg/kg)
- description
- Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG005
- title
- Biweekly Regimen (GEN1029 3.0 mg/kg)
- population Description
- Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 8.8 months (corresponding to maximum observed duration)
- title
- Duration of Response (DoR) According to RECIST 1.1
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice