TriangleNCT03215030 · OUTCOME
Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to 20.5 months in Part 3
What was measured
TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Analysis population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
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 | 37 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 4.7 | Not reported | 0.03 | 15.44 | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 5.5 | Not reported | 0.03 | 19.81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 15.44
- value
- 4.7
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 19.81
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
- dispersion Type
- Full Range
- 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 FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Up to 20.5 months in Part 3
- title
- Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice