TriangleNCT03576131 · OUTCOME
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- millimeter
- Interval / dispersion
- Standard Deviation
- Time frame
- From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
What was measured
Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.
Analysis population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual treatment received.
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) | 9 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 10 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 12.0 | 11.843 | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 12.0 | 17.616 | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 13.75 | 9.032 | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 1.10 | 9.049 | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 9.0 | 10.909 | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 15.50 | 18.574 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.843
- value
- 12.0
- group Id
- OG001
- spread
- 17.616
- value
- 12.0
- group Id
- OG002
- spread
- 9.032
- value
- 13.75
- group Id
- OG003
- spread
- 9.049
- value
- 1.10
- group Id
- OG004
- spread
- 10.909
- value
- 9.0
- group Id
- OG005
- spread
- 18.574
- value
- 15.50
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.
- dispersion Type
- Standard Deviation
- 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)
- param Type
- MEAN
- population Description
- Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual treatment received.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
- title
- Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
- type
- SECONDARY
- unit Of Measure
- millimeter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice