TriangleNCT03433001 · OUTCOME
PFS Rate at 12 Months and 24 Months After the Start of Treatment
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
- 12 months and 24 months
What was measured
PFS rate was defined as the percentage of participants who were alive and have not had disease progression at 12 months and 24 months after the date of start of study treatment. PFS was assessed by IMWG Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Analysis population: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
Groups in this outcome
Ixazomib + Lenalidomide + Dexamethasone
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
| Group | Source count |
|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | 295 |
Reported measurements
Month 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | 57 | Not reported | 51 | 63 | Not reported |
Month 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | 41 | Not reported | 35 | 47 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51
- upper Limit
- 63
- value
- 57
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35
- upper Limit
- 47
- value
- 41
- title
- Month 24
- denoms
- counts
- group Id
- OG000
- value
- 295
- units
- Participants
- description
- PFS rate was defined as the percentage of participants who were alive and have not had disease progression at 12 months and 24 months after the date of start of study treatment. PFS was assessed by IMWG Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
- id
- OG000
- title
- Ixazomib + Lenalidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
- reporting Status
- POSTED
- time Frame
- 12 months and 24 months
- title
- PFS Rate at 12 Months and 24 Months After the Start of Treatment
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice