TriangleNCT04407442 · 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
- Up to 18 months
What was measured
OS is defined as the date of first dose of study treatment to the date of death due to any cause or censored based on the date of last encounter if patient is alive or lost to follow-up. OS will be summarized using the Kaplan-Meier estimator. Median even-free survival will be reported and the corresponding 95% confidence interval will be calculated using Brookmeyer and Crowley method.
Groups in this outcome
Treatment (Azacitidine, Dexamethasone, Daratumumab)
PRE-INDUCTION (CYCLE 0): Patients receive azacitidine IV on days -7 to -3 in absence of disease progression or unacceptable toxicity. INDUCTION (CYCLES 1-2): Patients receive azacitidine IV on days 22-26, dexamethasone IV or orally (PO), and daratumumab subcutaneously (SC) over 3-5 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity CONSOLIDATION (CYCLES 3-6): Patients receive azacitidine IV on days 22-26 of cycle 3 and on days 1-5 of cycles 5-6, dexamethasone IV or PO, and daratumumab SC over 3-5 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity MAINTENANCE (CYCLES 7+): Patients receive azacitidine IV on days 1-5, dexamethasone IV or PO, and daratumumab SC over 3-5 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
| Group | Source count |
|---|---|
| Treatment (Azacitidine, Dexamethasone, Daratumumab) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Azacitidine, Dexamethasone, Daratumumab) | NA | Not reported | 10.1 | NA | There were insufficient number of events (N=1) to determine median OS and upper limit of confidence interval could not be calculated |
Complete source fields
- classes
- categories
- measurements
- comment
- There were insufficient number of events (N=1) to determine median OS and upper limit of confidence interval could not be calculated
- group Id
- OG000
- lower Limit
- 10.1
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- OS is defined as the date of first dose of study treatment to the date of death due to any cause or censored based on the date of last encounter if patient is alive or lost to follow-up. OS will be summarized using the Kaplan-Meier estimator. Median even-free survival will be reported and the corresponding 95% confidence interval will be calculated using Brookmeyer and Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- PRE-INDUCTION (CYCLE 0): Patients receive azacitidine IV on days -7 to -3 in absence of disease progression or unacceptable toxicity. INDUCTION (CYCLES 1-2): Patients receive azacitidine IV on days 22-26, dexamethasone IV or orally (PO), and daratumumab subcutaneously (SC) over 3-5 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity CONSOLIDATION (CYCLES 3-6): Patients receive azacitidine IV on days 22-26 of cycle 3 and on days 1-5 of cycles 5-6, dexamethasone IV or PO, and daratumumab SC over 3-5 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity MAINTENANCE (CYCLES 7+): Patients receive azacitidine IV on days 1-5, dexamethasone IV or PO, and daratumumab SC over 3-5 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
- id
- OG000
- title
- Treatment (Azacitidine, Dexamethasone, Daratumumab)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Up to 18 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