TriangleNCT02400437 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From start of treatment to time of disease progression, assessed up to 4 years after treatment start
What was measured
Duration of time from start of treatment to disease progression. Progressive disease is defined as occurring when a \>25% increase in serum IgM and an absolute 500mg/dL increase in IgM level occurs from the lowest attained response value, or progression of clinically significant disease related symptoms.
Analysis population: All participants who received at least 1 cycle of therapy. Participants were followed for up to 2 years after treatment discontinuation.
Groups in this outcome
Ixazomib, Dexamethasone, Rituximab
\- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Rituximab: Doses given on Day 1 of induction and maintenance cycles.
| Group | Source count |
|---|---|
| Ixazomib, Dexamethasone, Rituximab | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib, Dexamethasone, Rituximab | 33 | Not reported | 4 | 46 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 46
- value
- 33
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- Duration of time from start of treatment to disease progression. Progressive disease is defined as occurring when a \>25% increase in serum IgM and an absolute 500mg/dL increase in IgM level occurs from the lowest attained response value, or progression of clinically significant disease related symptoms.
- dispersion Type
- Full Range
- groups
- description
- \- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase Ixazomib: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Dexamethasone: Doses given on Days 1, 8, and 15 in induction and maintenance cycles. Rituximab: Doses given on Day 1 of induction and maintenance cycles.
- id
- OG000
- title
- Ixazomib, Dexamethasone, Rituximab
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 cycle of therapy. Participants were followed for up to 2 years after treatment discontinuation.
- reporting Status
- POSTED
- time Frame
- From start of treatment to time of disease progression, assessed up to 4 years after treatment start
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice