TriangleNCT01953692 · OUTCOME
Erythroid Response 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
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to approximately 78.5 months
What was measured
Erythroid response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Erythroid response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criteria for an erythroid response include: hemoglobin (Hgb) increase by ≥1.5 grams/deciliter (g/dl) from pretreatment or reduction of ≥4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only transfusions given for a Hgb of ≤9.0 g/dl pretreatment counted for response evaluation. The percentage of participants with an erythroid response as assessed by the investigator is presented.
Analysis population: All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
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) | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Myelodysplastic Syndrome (MDS) | 7.1 | Not reported | 1.3 | 21.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.3
- upper Limit
- 21.5
- value
- 7.1
- denoms
- counts
- group Id
- OG000
- value
- 27
- units
- Participants
- description
- Erythroid response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Erythroid response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criteria for an erythroid response include: hemoglobin (Hgb) increase by ≥1.5 grams/deciliter (g/dl) from pretreatment or reduction of ≥4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only transfusions given for a Hgb of ≤9.0 g/dl pretreatment counted for response evaluation. The percentage of participants with an erythroid response as assessed by the investigator is presented.
- dispersion Type
- 90% Confidence Interval
- 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)
- param Type
- NUMBER
- population Description
- All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Erythroid Response in Cohort 1: Myelodysplastic Syndrome (MDS)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice