TriangleNCT01441973 · OUTCOME
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 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
- From day of last patient, first dose to 6 months
What was measured
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Analysis population: All participants who received at least 1 dose of study drug
Groups in this outcome
Elotuzumab, 20 mg/kg
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Elotuzumab, 10 mg/kg
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
Elotuzumab, All Dosages
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
| Group | Source count |
|---|---|
| Elotuzumab, 20 mg/kg | 15 |
| Elotuzumab, 10 mg/kg | 16 |
| Elotuzumab, All Dosages | 31 |
Reported measurements
Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, 10 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, All Dosages | 0 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, 20 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, 10 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, All Dosages | 15 | Not reported | Not reported | Not reported | Not reported |
AEs leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, 20 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, 10 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, All Dosages | 6 | Not reported | Not reported | Not reported | Not reported |
Infusion reactions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, 20 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, 10 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Elotuzumab, All Dosages | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Deaths
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 15
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- title
- AEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- title
- Infusion reactions
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
- groups
- description
- Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
- id
- OG000
- title
- Elotuzumab, 20 mg/kg
- description
- Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
- id
- OG001
- title
- Elotuzumab, 10 mg/kg
- description
- All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
- id
- OG002
- title
- Elotuzumab, All Dosages
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- From day of last patient, first dose to 6 months
- title
- Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice