NCT03088540 · OUTCOME
Number of Participants With Anti-Cemiplimab Antibodies (ADA)
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
- Up to 73.5 months
What was measured
The ADA status of each participant was classified as one of the following: * Pre-existing - If the baseline sample is positive and all post baseline ADA titers are reported as less than 9-fold the baseline titer value * Negative - If all samples are found to be negative in the ADA assay * Treatment-emergent response
Analysis population: The ADA analysis set (AAS) included all participants who received any cemiplimab and who had at least 1 post-dose ADA result.
Groups in this outcome
Cemiplimab
Participants received cemiplimab monotherapy
| Group | Source count |
|---|---|
| Cemiplimab | 255 |
Reported measurements
Source class 1
Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cemiplimab | 241 | Not reported | Not reported | Not reported | Not reported |
Pre-existing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cemiplimab | 9 | Not reported | Not reported | Not reported | Not reported |
Treatment-emergent Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cemiplimab | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 241
- title
- Negative
- measurements
- group Id
- OG000
- value
- 9
- title
- Pre-existing
- measurements
- group Id
- OG000
- value
- 5
- title
- Treatment-emergent Response
- denoms
- counts
- group Id
- OG000
- value
- 255
- units
- Participants
- description
- The ADA status of each participant was classified as one of the following: * Pre-existing - If the baseline sample is positive and all post baseline ADA titers are reported as less than 9-fold the baseline titer value * Negative - If all samples are found to be negative in the ADA assay * Treatment-emergent response
- groups
- description
- Participants received cemiplimab monotherapy
- id
- OG000
- title
- Cemiplimab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The ADA analysis set (AAS) included all participants who received any cemiplimab and who had at least 1 post-dose ADA result.
- reporting Status
- POSTED
- time Frame
- Up to 73.5 months
- title
- Number of Participants With Anti-Cemiplimab Antibodies (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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