TriangleNCT02631070 · OUTCOME
Participants With Pre-Existing and/or Treatment-Emergent Antidrug 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
- From randomization to 1 year post first dose
What was measured
Number of participants with positive ADA prior to taking study drug and/or during study. A participant was counted as "treatment-emergent" if there was a positive post-baseline sample while the baseline sample was ADA negative, or there was a positive post-baseline sample with a titer ≥ 4-fold of the baseline titer while the baseline sample was ADA positive. A participant was counted as "preexisting" if the baseline sample was ADA positive and the participant was not qualified for "treatment-emergent."
Analysis population: Safety population of participants with ADA samples collected.
Groups in this outcome
Luspatercept
Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
Placebo
Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
| Group | Source count |
|---|---|
| Luspatercept | 153 |
| Placebo | 76 |
Reported measurements
Pre-Existing ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 7 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
Treatment Emergent ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 11 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
Treatment Emergent Neutralizing ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept | 5 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- title
- Pre-Existing ADA
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 3
- title
- Treatment Emergent ADA
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- title
- Treatment Emergent Neutralizing ADA
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- Number of participants with positive ADA prior to taking study drug and/or during study. A participant was counted as "treatment-emergent" if there was a positive post-baseline sample while the baseline sample was ADA negative, or there was a positive post-baseline sample with a titer ≥ 4-fold of the baseline titer while the baseline sample was ADA positive. A participant was counted as "preexisting" if the baseline sample was ADA positive and the participant was not qualified for "treatment-emergent."
- groups
- description
- Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
- id
- OG000
- title
- Luspatercept
- description
- Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population of participants with ADA samples collected.
- reporting Status
- POSTED
- time Frame
- From randomization to 1 year post first dose
- title
- Participants With Pre-Existing and/or Treatment-Emergent Antidrug Antibodies (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice