TriangleNCT01953692 · OUTCOME
Duration of Response (DOR) in Cohort 1: Myelodysplastic Syndrome (MDS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 78.5 months
What was measured
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still \>5%. Cellularity and morphology are not relevant. DOR as assessed by the investigator is presented.
Analysis population: All participants in Cohort 1 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a PR or CR. DOR was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
Groups in this outcome
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
| Group | Source count |
|---|---|
| Cohort 1: Myelodysplastic Syndrome (MDS) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still \>5%. Cellularity and morphology are not relevant. DOR as assessed by the investigator is presented.
- groups
- description
- Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 1: Myelodysplastic Syndrome (MDS)
- population Description
- All participants in Cohort 1 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a PR or CR. DOR was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Duration of Response (DOR) in Cohort 1: Myelodysplastic Syndrome (MDS)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice