TriangleNCT01881789 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (AEs)
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 first dose of any study treatment to 30 days after last dose; median duration of treatment was 29.1, 12.4, 11.3, 66.6, 7.8, and 46.4 weeks in each treatment group, respectively.
What was measured
Adverse events (AEs) were graded using NCI-CTCAE (version 4.03) and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. A serious AE is an event that met 1 or more of the following criteria: * Death * Life-threatening experience * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly birth defect in the offspring of an exposed female subject or offspring of a female partner of a male subject * Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent an outcome listed above. Treatment-related AEs are those considered related to at least 1 study drug by the investigator.
Analysis population: Participants who received at least 1 dose of any study treatment
Groups in this outcome
Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first. After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment.
| Group | Source count |
|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 7 |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 3 |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 3 |
Reported measurements
Any treatment-emergent adverse event (TEAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
TEAE ≥ grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
TEAEs leading to discontinuation of study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
Fatal adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment-related adverse events (TRAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
TRAE ≥ grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Treatment-related serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
TRAEs leading to discontinuation of study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- title
- Any treatment-emergent adverse event (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- title
- TEAE ≥ grade 3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- TEAEs leading to discontinuation of study drug
- 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
- group Id
- OG005
- value
- 0
- title
- Fatal adverse events
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- title
- Treatment-related adverse events (TRAE)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- title
- TRAE ≥ grade 3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- title
- Treatment-related serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- TRAEs leading to discontinuation of study drug
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- Adverse events (AEs) were graded using NCI-CTCAE (version 4.03) and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. A serious AE is an event that met 1 or more of the following criteria: * Death * Life-threatening experience * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly birth defect in the offspring of an exposed female subject or offspring of a female partner of a male subject * Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent an outcome listed above. Treatment-related AEs are those considered related to at least 1 study drug by the investigator.
- groups
- description
- Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG000
- title
- Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG001
- title
- Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.
- id
- OG002
- title
- Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG003
- title
- Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first. After completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG004
- title
- Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone
- description
- Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first. After completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment.
- id
- OG005
- title
- Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least 1 dose of any study treatment
- reporting Status
- POSTED
- time Frame
- From first dose of any study treatment to 30 days after last dose; median duration of treatment was 29.1, 12.4, 11.3, 66.6, 7.8, and 46.4 weeks in each treatment group, respectively.
- title
- Number of Participants With Treatment-emergent Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice