TriangleNCT03748953 · OUTCOME
Correlation Between Frailty Status and 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
- Up to 58.4 months
What was measured
Participant's frailty status is classified as fit, unfit, or frail on the basis of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator.
Analysis population: Efficacy Population included all participants who received ixazomib treatment for the duration of their study participation. Number analyzed is the number of participants with data available for analysis for the specified category. 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 SAP), 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
Frailty Status: Fit
| Group | Source count |
|---|---|
| Ixazomib | 25 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib | NA | Not reported | 12.68 | NA | Median and upper limit of 95% CI were not estimable due to censoring. |
Frailty Status: Unfit
| Group | Source count |
|---|---|
| Ixazomib | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib | 20.9 | Not reported | 0.89 | NA | Upper limit of 95% CI was not estimable due to censoring. |
Frailty Status: Frail
| Group | Source count |
|---|---|
| Ixazomib | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib | 6.5 | Not reported | 6.18 | NA | Upper limit of 95% CI was not estimable due to censoring. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% CI were not estimable due to censoring.
- group Id
- OG000
- lower Limit
- 12.68
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- title
- Frailty Status: Fit
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to censoring.
- group Id
- OG000
- lower Limit
- 0.89
- upper Limit
- NA
- value
- 20.9
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- title
- Frailty Status: Unfit
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to censoring.
- group Id
- OG000
- lower Limit
- 6.18
- upper Limit
- NA
- value
- 6.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- title
- Frailty Status: Frail
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- description
- Participant's frailty status is classified as fit, unfit, or frail on the basis of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator.
- 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. Number analyzed is the number of participants with data available for analysis for the specified category. 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 SAP), thus data is presented accordingly.
- reporting Status
- POSTED
- time Frame
- Up to 58.4 months
- title
- Correlation Between Frailty Status and PFS
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice