TriangleNCT00963820 · OUTCOME
Neurotoxicity Grading
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 and End of Study (Up to 354 days)
What was measured
Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.
Analysis population: Safety Population included all randomized participants who received study drug.
Groups in this outcome
0.24 mg/m^2
Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
0.48 mg/m^2
Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
0.80 mg/m^2
Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
1.20 mg/m^2
Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
1.68 mg/m^2
Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
2.23 mg/m^2
Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
2.97 mg/m^2
Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
3.95 mg/m^2
Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
Relapsed and Refractory (RR)
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
VELCADE-relapsed (VR)
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
PI naïve
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
Carfilzomib
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
| Group | Source count |
|---|---|
| 0.24 mg/m^2 | 3 |
| 0.48 mg/m^2 | 3 |
| 0.80 mg/m^2 | 3 |
| 1.20 mg/m^2 | 3 |
| 1.68 mg/m^2 | 4 |
| 2.23 mg/m^2 | 3 |
| 2.97 mg/m^2 | 8 |
| 3.95 mg/m^2 | 5 |
| Relapsed and Refractory (RR) | 11 |
| VELCADE-relapsed (VR) | 10 |
| PI naïve | 6 |
| Carfilzomib | 4 |
Reported measurements
Cycle 1 Day 1 (n=2,3,3,3,4,3,7,4,9,8,6,4)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.24 mg/m^2 | 36.00 | 9.899 | Not reported | Not reported | Not reported |
| 0.48 mg/m^2 | 40.33 | 1.155 | Not reported | Not reported | Not reported |
| 0.80 mg/m^2 | 42.00 | 3.464 | Not reported | Not reported | Not reported |
| 1.20 mg/m^2 | 36.00 | 7.937 | Not reported | Not reported | Not reported |
| 1.68 mg/m^2 | 39.50 | 2.646 | Not reported | Not reported | Not reported |
| 2.23 mg/m^2 | 36.80 | 4.530 | Not reported | Not reported | Not reported |
| 2.97 mg/m^2 | 33.14 | 7.841 | Not reported | Not reported | Not reported |
| 3.95 mg/m^2 | 38.50 | 4.203 | Not reported | Not reported | Not reported |
| Relapsed and Refractory (RR) | 38.44 | 5.053 | Not reported | Not reported | Not reported |
| VELCADE-relapsed (VR) | 33.73 | 6.935 | Not reported | Not reported | Not reported |
| PI naïve | 38.00 | 6.928 | Not reported | Not reported | Not reported |
| Carfilzomib | 32.00 | 8.367 | Not reported | Not reported | Not reported |
End of Study (n=3,3,2,1,1,3,4,3,8,5,4,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.24 mg/m^2 | 25.00 | 3.606 | Not reported | Not reported | Not reported |
| 0.48 mg/m^2 | 40.67 | 2.517 | Not reported | Not reported | Not reported |
| 0.80 mg/m^2 | 38.50 | 3.536 | Not reported | Not reported | Not reported |
| 1.20 mg/m^2 | 35.00 | 0.000 | Not reported | Not reported | Not reported |
| 1.68 mg/m^2 | 42.00 | 0.000 | Not reported | Not reported | Not reported |
| 2.23 mg/m^2 | 36.00 | 3.606 | Not reported | Not reported | Not reported |
| 2.97 mg/m^2 | 36.00 | 7.528 | Not reported | Not reported | Not reported |
| 3.95 mg/m^2 | 33.33 | 8.386 | Not reported | Not reported | Not reported |
| Relapsed and Refractory (RR) | 33.88 | 9.219 | Not reported | Not reported | Not reported |
| VELCADE-relapsed (VR) | 27.24 | 13.122 | Not reported | Not reported | Not reported |
| PI naïve | 37.00 | 5.944 | Not reported | Not reported | Not reported |
| Carfilzomib | 27.33 | 7.371 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.899
- value
- 36.00
- group Id
- OG001
- spread
- 1.155
- value
- 40.33
- group Id
- OG002
- spread
- 3.464
- value
- 42.00
- group Id
- OG003
- spread
- 7.937
- value
- 36.00
- group Id
- OG004
- spread
- 2.646
- value
- 39.50
- group Id
- OG005
- spread
- 4.530
- value
- 36.80
- group Id
- OG006
- spread
- 7.841
- value
- 33.14
- group Id
- OG007
- spread
- 4.203
- value
- 38.50
- group Id
- OG008
- spread
- 5.053
- value
- 38.44
- group Id
- OG009
- spread
- 6.935
- value
- 33.73
- group Id
- OG010
- spread
- 6.928
- value
- 38.00
- group Id
- OG011
- spread
- 8.367
- value
- 32.00
- title
- Cycle 1 Day 1 (n=2,3,3,3,4,3,7,4,9,8,6,4)
- categories
- measurements
- group Id
- OG000
- spread
- 3.606
- value
- 25.00
- group Id
- OG001
- spread
- 2.517
- value
- 40.67
- group Id
- OG002
- spread
- 3.536
- value
- 38.50
- group Id
- OG003
- spread
- 0.000
- value
- 35.00
- group Id
- OG004
- spread
- 0.000
- value
- 42.00
- group Id
- OG005
- spread
- 3.606
- value
- 36.00
- group Id
- OG006
- spread
- 7.528
- value
- 36.00
- group Id
- OG007
- spread
- 8.386
- value
- 33.33
- group Id
- OG008
- spread
- 9.219
- value
- 33.88
- group Id
- OG009
- spread
- 13.122
- value
- 27.24
- group Id
- OG010
- spread
- 5.944
- value
- 37.00
- group Id
- OG011
- spread
- 7.371
- value
- 27.33
- title
- End of Study (n=3,3,2,1,1,3,4,3,8,5,4,3)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 6
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.
- dispersion Type
- Standard Deviation
- groups
- description
- Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG000
- title
- 0.24 mg/m^2
- description
- Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG001
- title
- 0.48 mg/m^2
- description
- Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG002
- title
- 0.80 mg/m^2
- description
- Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG003
- title
- 1.20 mg/m^2
- description
- Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG004
- title
- 1.68 mg/m^2
- description
- Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG005
- title
- 2.23 mg/m^2
- description
- Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG006
- title
- 2.97 mg/m^2
- description
- Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG007
- title
- 3.95 mg/m^2
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG008
- title
- Relapsed and Refractory (RR)
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG009
- title
- VELCADE-relapsed (VR)
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG010
- title
- PI naïve
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG011
- title
- Carfilzomib
- param Type
- MEAN
- population Description
- Safety Population included all randomized participants who received study drug.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 and End of Study (Up to 354 days)
- title
- Neurotoxicity Grading
- type
- PRIMARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice