TriangleNCT03215030 · OUTCOME
Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 20.5 months in Part 3
What was measured
Duration of MRD negativity (10\^-5) was defined as the time from the first MRD negative status (10\^-5) to the earliest date of the MRD positive status (10\^-5), confirmed PD per IMWG or death.
Analysis population: The ITT Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed is the number of participants from ITT analysis set who achieved CR.
Groups in this outcome
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
| Group | Source count |
|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 1 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | NA | NA | Not reported | Not reported | Due to insufficient number of participants the median of duration of MRD negativity could not be accurately obtained. |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | NA | NA | Not reported | Not reported | Due to insufficient number of participants the median of duration of MRD negativity could not be accurately obtained. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to insufficient number of participants the median of duration of MRD negativity could not be accurately obtained.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Due to insufficient number of participants the median of duration of MRD negativity could not be accurately obtained.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Duration of MRD negativity (10\^-5) was defined as the time from the first MRD negative status (10\^-5) to the earliest date of the MRD positive status (10\^-5), confirmed PD per IMWG or death.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG000
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG001
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- param Type
- MEDIAN
- population Description
- The ITT Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed is the number of participants from ITT analysis set who achieved CR.
- reporting Status
- POSTED
- time Frame
- Up to 20.5 months in Part 3
- title
- Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice