TriangleNCT02441686 · OUTCOME
Four-cycle Induction Peripheral Neuropathy (PN) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Participants were followed up to 12 weeks.
What was measured
Four-cycle induction PN rate was defined as the proportion of participants who experienced peripheral neuropathy includes any attribution and any grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) during the first 4 cycles of induction therapy.
Analysis population: Safety- all treated population.
Groups in this outcome
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
| Group | Source count |
|---|---|
| Lenalidomide, Subcutaneous Bortezomib, Dexamethasone | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide, Subcutaneous Bortezomib, Dexamethasone | 0.71 | Not reported | 0.58 | 0.83 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.58
- upper Limit
- 0.83
- value
- 0.71
- denoms
- counts
- group Id
- OG000
- value
- 42
- units
- Participants
- description
- Four-cycle induction PN rate was defined as the proportion of participants who experienced peripheral neuropathy includes any attribution and any grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) during the first 4 cycles of induction therapy.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
- id
- OG000
- title
- Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
- param Type
- NUMBER
- population Description
- Safety- all treated population.
- reporting Status
- POSTED
- time Frame
- Participants were followed up to 12 weeks.
- title
- Four-cycle Induction Peripheral Neuropathy (PN) Rate
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice