TriangleNCT03029234 · OUTCOME
Overall Survival (OS)
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 first dose until the data cut-off date of 15 March 2019; median time on follow-up for survival was 15.3 months.
What was measured
Overall survival (OS) is defined as the time from the first dose of any study treatment to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at their date of last contact (last known to be alive).
Analysis population: Safety population
Groups in this outcome
Carfilzomib With Dexamethasone
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 123 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Dexamethasone | 15.2 | Not reported | 11.5 | NA | Could not be estimated due to the low number of events at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events at the time of the analysis.
- group Id
- OG000
- lower Limit
- 11.5
- upper Limit
- NA
- value
- 15.2
- denoms
- counts
- group Id
- OG000
- value
- 123
- units
- Participants
- description
- Overall survival (OS) is defined as the time from the first dose of any study treatment to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at their date of last contact (last known to be alive).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
- id
- OG000
- title
- Carfilzomib With Dexamethasone
- param Type
- MEDIAN
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- From first dose until the data cut-off date of 15 March 2019; median time on follow-up for survival was 15.3 months.
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice