TriangleNCT03576131 · OUTCOME
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
What was measured
From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.
Analysis population: The Immunogenicity Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual treatment received and had at least one immunogenicity measurement taken.
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) | 10 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 5 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 5 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 7 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 5 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The Immunogenicity Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual treatment received and had at least one immunogenicity measurement taken.
- reporting Status
- POSTED
- time Frame
- From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
- title
- Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice