TriangleNCT02400437 · OUTCOME
Overall Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 2 Years
What was measured
Overall response includes the rate of complete response (CR), partial response (PR), minimal response (MR), stabl disease (SD) and progressive disease (PD). Minor response is \>25%-50% reduction in serum IgM from baseline. Partial Response is (\>50-90% reduction in serum IgM from baseline. Very Good Partial Response is \>90% reduction in serum IgM from baseline. Complete Response is resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly.
Analysis population: All participants who received at least 1 cycle of therapy.
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 | 25 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- Overall response includes the rate of complete response (CR), partial response (PR), minimal response (MR), stabl disease (SD) and progressive disease (PD). Minor response is \>25%-50% reduction in serum IgM from baseline. Partial Response is (\>50-90% reduction in serum IgM from baseline. Very Good Partial Response is \>90% reduction in serum IgM from baseline. Complete Response is resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least 1 cycle of therapy.
- reporting Status
- POSTED
- time Frame
- 2 Years
- title
- Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice