TriangleNCT00742560 · OUTCOME
Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From screening through 60-day follow up period (up to 101 months)
What was measured
Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.
Analysis population: All participants who received at least one dose of study drug and with at least one evaluable post-dose sample.
Groups in this outcome
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
| Group | Source count |
|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone | 3 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone | 39 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 57
- units
- Participants
- description
- Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.
- groups
- description
- Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG000
- title
- Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG001
- title
- Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone
- description
- Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG002
- title
- Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of study drug and with at least one evaluable post-dose sample.
- reporting Status
- POSTED
- time Frame
- From screening through 60-day follow up period (up to 101 months)
- title
- Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice