TriangleNCT00742560 · OUTCOME
Number of Participants With Infusion Reactions
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)
What was measured
During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).
Analysis population: Safety population: All randomized participants who received at least 1 dose of study drug
Groups in this outcome
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
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 (Phase 1)
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 (Phase 1)
Elotuzumab 20 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 (Phase 2)
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 (Phase 2)
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 (Phase 1) | 3 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 22 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 36 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 37 |
Reported measurements
Any reaction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 20 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 5 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 5 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 12 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- title
- Any reaction
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Grade 5
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- title
- Grade 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 36
- group Id
- OG004
- value
- 37
- units
- Participants
- description
- During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).
- 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 (Phase 1)
- 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 (Phase 1)
- 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 (Phase 1)
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG003
- title
- Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
- description
- Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG004
- title
- Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
- param Type
- NUMBER
- population Description
- Safety population: All randomized participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)
- title
- Number of Participants With Infusion Reactions
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice