TriangleNCT04266301 · OUTCOME
Percentage of Participants With Either CR, or mCR, or PR, or HI in Each Treatment Arm According to International Working Group for MDS (IWG-MDS) as Per Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to approx. 52 months
What was measured
Response rate of participants with complete remission (CR), or marrow remission (mCR), or partial remission (PR), or hematologic improvement (HI). CR: where the Bone marrow: ≤ 5% blasts with normal maturation of all cell lineages and Peripheral blood: where Hgb ≥ 10 g/dL AND Platelets ≥ 100\*109/L AND Neutrophils ≥ 1.0\*109/L AND Peripheral blasts 0%. mCR: Bone marrow: ≤ 5% blasts and blast count decrease by ≥ 50% compared to baseline; Peripheralblood/transfusion: Marrow CR may be achieved with or without improved blood counts or with or without transfusions PR: All CR criteria except bone marrow: ≥50% decrease from baseline in blasts in bone marrow AND blast count in bone marrow \>5%. HI: restoration or enhancement of the function of the body's blood cell-producing system that must last as least 8 weeks.
Analysis population: FAS comprised of all participants to whom study treatment had been assigned by randomization.
Groups in this outcome
Sabatolimab (MBG453) + Azacitidine
Participants were randomized to sabatolimab plus Azacitidine
Placebo + Azacitidine
Participants were randomized to placebo plus Azacitidine
| Group | Source count |
|---|---|
| Sabatolimab (MBG453) + Azacitidine | 265 |
| Placebo + Azacitidine | 265 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sabatolimab (MBG453) + Azacitidine | 58.1 | Not reported | 51.9 | 64.1 | Not reported |
| Placebo + Azacitidine | 47.5 | Not reported | 41.4 | 53.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.9
- upper Limit
- 64.1
- value
- 58.1
- group Id
- OG001
- lower Limit
- 41.4
- upper Limit
- 53.7
- value
- 47.5
- denoms
- counts
- group Id
- OG000
- value
- 265
- group Id
- OG001
- value
- 265
- units
- Participants
- description
- Response rate of participants with complete remission (CR), or marrow remission (mCR), or partial remission (PR), or hematologic improvement (HI). CR: where the Bone marrow: ≤ 5% blasts with normal maturation of all cell lineages and Peripheral blood: where Hgb ≥ 10 g/dL AND Platelets ≥ 100\*109/L AND Neutrophils ≥ 1.0\*109/L AND Peripheral blasts 0%. mCR: Bone marrow: ≤ 5% blasts and blast count decrease by ≥ 50% compared to baseline; Peripheralblood/transfusion: Marrow CR may be achieved with or without improved blood counts or with or without transfusions PR: All CR criteria except bone marrow: ≥50% decrease from baseline in blasts in bone marrow AND blast count in bone marrow \>5%. HI: restoration or enhancement of the function of the body's blood cell-producing system that must last as least 8 weeks.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to sabatolimab plus Azacitidine
- id
- OG000
- title
- Sabatolimab (MBG453) + Azacitidine
- description
- Participants were randomized to placebo plus Azacitidine
- id
- OG001
- title
- Placebo + Azacitidine
- param Type
- NUMBER
- population Description
- FAS comprised of all participants to whom study treatment had been assigned by randomization.
- reporting Status
- POSTED
- time Frame
- up to approx. 52 months
- title
- Percentage of Participants With Either CR, or mCR, or PR, or HI in Each Treatment Arm According to International Working Group for MDS (IWG-MDS) as Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice