NCT03894618 · OUTCOME
Immunogenicity to SL-279252
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
- Approximately 32 months
What was measured
Number of participants with positive anti-drug antibody (ADA) titer, of those who were ADA negative at baseline
Analysis population: For arms 0.0001 and 0.001 mg/kg of IV SL-279252, there were no subjects who were ADA negative at baseline. For arms 12.0 and 24.0 mg/kg of IV SL-279252, ADA samples were not collected.
Groups in this outcome
SL-279252 (0.0001 mg/kg S1)
0.0001 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.001 mg/kg S1)
0.001 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.003 mg/kg S1)
0.003 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.01 mg/kg S1)
0.01 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.03 mg/kg S1)
0.03 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.1 mg/kg S1)
0.1 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.3 mg/kg S1)
0.3 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (1.0 mg/kg S1)
1.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (3.0 mg/kg S1)
3.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (6.0 mg/kg S1)
6.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (12.0 mg/kg S1)
12.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (24.0 mg/kg S1)
24.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
| Group | Source count |
|---|---|
| SL-279252 (0.0001 mg/kg S1) | 0 |
| SL-279252 (0.001 mg/kg S1) | 0 |
| SL-279252 (0.003 mg/kg S1) | 1 |
| SL-279252 (0.01 mg/kg S1) | 1 |
| SL-279252 (0.03 mg/kg S1) | 2 |
| SL-279252 (0.1 mg/kg S1) | 2 |
| SL-279252 (0.3 mg/kg S1) | 3 |
| SL-279252 (1.0 mg/kg S1) | 5 |
| SL-279252 (3.0 mg/kg S1) | 4 |
| SL-279252 (6.0 mg/kg S1) | 3 |
| SL-279252 (12.0 mg/kg S1) | 0 |
| SL-279252 (24.0 mg/kg S1) | 0 |
| SL-279252 (0.3 mg/kg S2) | 2 |
| SL-279252 (1.0 mg/kg S2) | 5 |
| SL-279252 (3.0 mg/kg S2) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SL-279252 (0.0001 mg/kg S1) | 0 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.001 mg/kg S1) | 0 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.003 mg/kg S1) | 0 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.01 mg/kg S1) | 1 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.03 mg/kg S1) | 1 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.1 mg/kg S1) | 2 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1) | 1 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1) | 1 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1) | 3 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 1 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 0 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 0 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S2) | 1 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S2) | 3 | Not reported | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S2) | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- description
- Number of participants with positive anti-drug antibody (ADA) titer, of those who were ADA negative at baseline
- groups
- description
- 0.0001 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG000
- title
- SL-279252 (0.0001 mg/kg S1)
- description
- 0.001 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG001
- title
- SL-279252 (0.001 mg/kg S1)
- description
- 0.003 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG002
- title
- SL-279252 (0.003 mg/kg S1)
- description
- 0.01 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG003
- title
- SL-279252 (0.01 mg/kg S1)
- description
- 0.03 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG004
- title
- SL-279252 (0.03 mg/kg S1)
- description
- 0.1 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG005
- title
- SL-279252 (0.1 mg/kg S1)
- description
- 0.3 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG006
- title
- SL-279252 (0.3 mg/kg S1)
- description
- 1.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG007
- title
- SL-279252 (1.0 mg/kg S1)
- description
- 3.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG008
- title
- SL-279252 (3.0 mg/kg S1)
- description
- 6.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG009
- title
- SL-279252 (6.0 mg/kg S1)
- description
- 12.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG010
- title
- SL-279252 (12.0 mg/kg S1)
- description
- 24.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG011
- title
- SL-279252 (24.0 mg/kg S1)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- For arms 0.0001 and 0.001 mg/kg of IV SL-279252, there were no subjects who were ADA negative at baseline. For arms 12.0 and 24.0 mg/kg of IV SL-279252, ADA samples were not collected.
- reporting Status
- POSTED
- time Frame
- Approximately 32 months
- title
- Immunogenicity to SL-279252
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
Triangle