TriangleNCT01335685 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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 first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years
What was measured
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Analysis population: The safety population consisted of participants who received at least 1 dose of any study drug.
Groups in this outcome
Arm A: Ixazomib 3.0 mg
Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \[34 months\]).
Arm A: Ixazomib 3.7 mg
Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \[21 months\]).
Arm B: Ixazomib 3.0 mg
Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \[25 months\]).
Arm B: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
Arm B: Ixazomib 5.5 mg
Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \[24 months\]).
Arm C: Ixazomib 3.0 mg
Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \[40 months\]).
Arm C: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \[24 months\]).
Arm D: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \[38 months\]).
| Group | Source count |
|---|---|
| Arm A: Ixazomib 3.0 mg | 7 |
| Arm A: Ixazomib 3.7 mg | 4 |
| Arm B: Ixazomib 3.0 mg | 3 |
| Arm B: Ixazomib 4.0 mg | 26 |
| Arm B: Ixazomib 5.5 mg | 5 |
| Arm C: Ixazomib 3.0 mg | 6 |
| Arm C: Ixazomib 4.0 mg | 4 |
| Arm D: Ixazomib 4.0 mg | 6 |
Reported measurements
During Entire Study Any Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Ixazomib 3.0 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Ixazomib 3.7 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 3.0 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 4.0 mg | 26 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 5.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 3.0 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 4.0 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Ixazomib 4.0 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or Higher Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Ixazomib 3.0 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Ixazomib 3.7 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 3.0 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 4.0 mg | 21 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 5.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 3.0 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 4.0 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Ixazomib 4.0 mg | 5 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Ixazomib 3.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Ixazomib 3.7 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 3.0 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 4.0 mg | 12 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 5.5 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 3.0 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 4.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Ixazomib 4.0 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Adverse Event With Any Study Drug Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Ixazomib 3.0 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Ixazomib 3.7 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 3.0 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 4.0 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 5.5 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 3.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 4.0 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Ixazomib 4.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Adverse Event With Any Study Drug Reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Ixazomib 3.0 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Ixazomib 3.7 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 3.0 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 4.0 mg | 13 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Ixazomib 5.5 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 3.0 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Ixazomib 4.0 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Ixazomib 4.0 mg | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 6
- title
- During Entire Study Any Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 5
- title
- Grade 3 or Higher Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- title
- Serious Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- title
- Adverse Event With Any Study Drug Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 4
- title
- Adverse Event With Any Study Drug Reduction
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
- groups
- description
- Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \[34 months\]).
- id
- OG000
- title
- Arm A: Ixazomib 3.0 mg
- description
- Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \[21 months\]).
- id
- OG001
- title
- Arm A: Ixazomib 3.7 mg
- description
- Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \[25 months\]).
- id
- OG002
- title
- Arm B: Ixazomib 3.0 mg
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
- id
- OG003
- title
- Arm B: Ixazomib 4.0 mg
- description
- Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \[24 months\]).
- id
- OG004
- title
- Arm B: Ixazomib 5.5 mg
- description
- Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \[40 months\]).
- id
- OG005
- title
- Arm C: Ixazomib 3.0 mg
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \[24 months\]).
- id
- OG006
- title
- Arm C: Ixazomib 4.0 mg
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \[38 months\]).
- id
- OG007
- title
- Arm D: Ixazomib 4.0 mg
- param Type
- NUMBER
- population Description
- The safety population consisted of participants who received at least 1 dose of any study drug.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice