TriangleNCT00742560 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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
- Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
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 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | 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) | 22 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 36 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 37 | Not reported | Not reported | Not reported | Not reported |
Any TESAE
| 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) | 3 | 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) | 21 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 21 | Not reported | Not reported | Not reported | Not reported |
TEAEs ≥ Grade 3
| 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) | 19 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 32 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 25 | Not reported | Not reported | Not reported | Not reported |
TEAEs related to study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | 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) | 16 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 29 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 26 | Not reported | Not reported | Not reported | Not reported |
TESAEs related to study drug
| 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) | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 21
- title
- Any TESAE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 32
- group Id
- OG004
- value
- 25
- title
- TEAEs ≥ Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 26
- title
- TEAEs related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- title
- TESAEs related to study drug
- 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
- An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
- 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
- Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice