TriangleNCT03748953 · 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
- 95% Confidence Interval
- Time frame
- From the first dose of study drug to every 4 weeks until PD or death from any cause (up to 58.4 months)
What was measured
PFS was defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator or death from any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase \>10 milligrams per deciliter \[mg/dL\]); bone marrow plasma cell percent ≥10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Analysis population: Efficacy Population included all participants who received ixazomib treatment for the duration of their study participation. As prespecified in the SAP, the Efficacy Population contained only one arm i.e., Ixazomib (efficacy outcomes data for the participants who received placebo before Protocol Amendment 8 was not collected per statistical analysis plan), thus data is presented accordingly.
Groups in this outcome
Ixazomib
Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).
| Group | Source count |
|---|---|
| Ixazomib | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib | 21.3 | Not reported | 9.20 | NA | Upper limit of 95% confidence interval (CI) was not estimable due to censoring. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% confidence interval (CI) was not estimable due to censoring.
- group Id
- OG000
- lower Limit
- 9.20
- upper Limit
- NA
- value
- 21.3
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- description
- PFS was defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator or death from any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase \>10 milligrams per deciliter \[mg/dL\]); bone marrow plasma cell percent ≥10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).
- id
- OG000
- title
- Ixazomib
- param Type
- MEDIAN
- population Description
- Efficacy Population included all participants who received ixazomib treatment for the duration of their study participation. As prespecified in the SAP, the Efficacy Population contained only one arm i.e., Ixazomib (efficacy outcomes data for the participants who received placebo before Protocol Amendment 8 was not collected per statistical analysis plan), thus data is presented accordingly.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug to every 4 weeks until PD or death from any cause (up to 58.4 months)
- 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