TriangleNCT03110562 · OUTCOME
SVd/Vd Arm: Change From Baseline in Participant-Reported Peripheral Neuropathy (PN) Assessed by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire- Chemotherapy-Induced PN 20 (EORTC- QLQ-CIPN20) Total Scores
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
- Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848)
What was measured
The EORTC QLQ-CIPN20 instrument is a 20-item QoL instrument, which has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN. The QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) containing a 4-point Likert scale (1= not at all, 2= a little, 3= quite a bit, and 4= very much), participants indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a total score with range of 0-100 scale, with higher scores indicating more symptom burden.
Analysis population: The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Data was not planned to be reported for SVdx arm and Sdx arm.
Groups in this outcome
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m\^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
Vd Arm: Bortezomib + Dexamethasone
Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
| Group | Source count |
|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 71 |
| Vd Arm: Bortezomib + Dexamethasone | 58 |
Reported measurements
Total Sensory Score: Change at EOT
| Group | Source count |
|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 71 |
| Vd Arm: Bortezomib + Dexamethasone | 58 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 3.38 | 12.436 | Not reported | Not reported | Not reported |
| Vd Arm: Bortezomib + Dexamethasone | 11.17 | 19.069 | Not reported | Not reported | Not reported |
Total Motor Score: Change at EOT
| Group | Source count |
|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 71 |
| Vd Arm: Bortezomib + Dexamethasone | 58 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 3.56 | 14.513 | Not reported | Not reported | Not reported |
| Vd Arm: Bortezomib + Dexamethasone | 9.02 | 18.662 | Not reported | Not reported | Not reported |
Total Autonomic Score: Change at EOT
| Group | Source count |
|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 71 |
| Vd Arm: Bortezomib + Dexamethasone | 57 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 10.41 | 22.201 | Not reported | Not reported | Not reported |
| Vd Arm: Bortezomib + Dexamethasone | 10.92 | 25.306 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.436
- value
- 3.38
- group Id
- OG001
- spread
- 19.069
- value
- 11.17
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Total Sensory Score: Change at EOT
- categories
- measurements
- group Id
- OG000
- spread
- 14.513
- value
- 3.56
- group Id
- OG001
- spread
- 18.662
- value
- 9.02
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Total Motor Score: Change at EOT
- categories
- measurements
- group Id
- OG000
- spread
- 22.201
- value
- 10.41
- group Id
- OG001
- spread
- 25.306
- value
- 10.92
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 57
- units
- Participants
- title
- Total Autonomic Score: Change at EOT
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- The EORTC QLQ-CIPN20 instrument is a 20-item QoL instrument, which has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN. The QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) containing a 4-point Likert scale (1= not at all, 2= a little, 3= quite a bit, and 4= very much), participants indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a total score with range of 0-100 scale, with higher scores indicating more symptom burden.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m\^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
- id
- OG000
- title
- SVd Arm: Selinexor + Bortezomib + Dexamethasone
- description
- Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
- id
- OG001
- title
- Vd Arm: Bortezomib + Dexamethasone
- param Type
- MEAN
- population Description
- The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Data was not planned to be reported for SVdx arm and Sdx arm.
- reporting Status
- POSTED
- time Frame
- Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848)
- title
- SVd/Vd Arm: Change From Baseline in Participant-Reported Peripheral Neuropathy (PN) Assessed by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire- Chemotherapy-Induced PN 20 (EORTC- QLQ-CIPN20) Total Scores
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice