TriangleNCT01383928 · OUTCOME
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity
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
- Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
What was measured
TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death. Only TEAEs related to neurotoxicity with values are reported.
Analysis population: Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.
Groups in this outcome
Phase 1: Ixazomib 3 mg
Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
Phase 1: Ixazomib 3.7 mg
Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
| Group | Source count |
|---|---|
| Phase 1: Ixazomib 3 mg | 7 |
| Phase 1: Ixazomib 3.7 mg | 7 |
Reported measurements
Neuropathy Peripheral (Grade 1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Neuropathy Peripheral (Grade 2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Neuropathy Peripheral (Grade 3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Peripheral Sensory Neuropathy (Grade 1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Peripheral Sensory Neuropathy (Grade 2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Peripheral Sensory Neuropathy (Grade 3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Peripheral Motor Neuropathy (Grade 1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Ixazomib 3 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Ixazomib 3.7 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Neuropathy Peripheral (Grade 1)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Neuropathy Peripheral (Grade 2)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Neuropathy Peripheral (Grade 3)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Peripheral Sensory Neuropathy (Grade 1)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Peripheral Sensory Neuropathy (Grade 2)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Peripheral Sensory Neuropathy (Grade 3)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Peripheral Motor Neuropathy (Grade 1)
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death. Only TEAEs related to neurotoxicity with values are reported.
- groups
- description
- Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
- id
- OG000
- title
- Phase 1: Ixazomib 3 mg
- description
- Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
- id
- OG001
- title
- Phase 1: Ixazomib 3.7 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
- title
- Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice