TriangleNCT01818752 · OUTCOME
Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
What was measured
Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.
Analysis population: The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone).
Groups in this outcome
Bortezomib, Melphalan, Prednisone
Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Carfilzomib, Melphalan, Prednisone
Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
| Group | Source count |
|---|---|
| Bortezomib, Melphalan, Prednisone | 470 |
| Carfilzomib, Melphalan, Prednisone | 474 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib, Melphalan, Prednisone | 35.1 | Not reported | 30.8 | 39.6 | Not reported |
| Carfilzomib, Melphalan, Prednisone | 2.5 | Not reported | 1.3 | 4.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.026
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.088
- estimate Comment
- Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- < 0.0001
- p Value Comment
- Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.
- param Type
- Odds Ratio (OR)
- param Value
- 0.048
- statistical Method
- Pearson Chi-Square test
Complete source fields
- analyses
- ci Lower Limit
- 0.026
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.088
- estimate Comment
- Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- < 0.0001
- p Value Comment
- Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.
- param Type
- Odds Ratio (OR)
- param Value
- 0.048
- statistical Method
- Pearson Chi-Square test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.8
- upper Limit
- 39.6
- value
- 35.1
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- 4.4
- value
- 2.5
- denoms
- counts
- group Id
- OG000
- value
- 470
- group Id
- OG001
- value
- 474
- units
- Participants
- description
- Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG000
- title
- Bortezomib, Melphalan, Prednisone
- description
- Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG001
- title
- Carfilzomib, Melphalan, Prednisone
- param Type
- NUMBER
- population Description
- The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone).
- reporting Status
- POSTED
- time Frame
- From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
- title
- Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice