TriangleNCT01943851 · OUTCOME
Part 2: Objective Response Rate (ORR) (MDS Cohort)
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 36.4 weeks
What was measured
ORR for MDS cohort is defined as the percentage of participants achieving Complete Response (CR), Marrow CR, CRp (as per CR but platelet count \<100 x 10\^9 cells/Liter\[L\]), CRi (as per CR but platelet count \<100 x 10\^9cells/L or neutrophil count \<1 x 10\^9 cells/L), or Partial Response (PR) per response criteria. Complete response is defined as bone marrow \<=5% myeloblasts with normal maturation of all cell lines, with hemoglobin concentration of \>=11 grams per deciliter (g/dL), absolute neutrophil count \>=1 x 10\^9 cells/L, platelet count \>=100x10\^9 cells/L and 0% blasts in the peripheral blood. Marrow CR is defined as Bone marrow \<=5% myeloblasts and decrease by \>=50% over pre-treatment. Objective response rate was determined by the investigator according to international myeloma working group (IMWG) response criteria.
Analysis population: All Treated Population
Groups in this outcome
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
| Group | Source count |
|---|---|
| Part 2: GSK525762 75 mg QD MDS | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 75 mg QD MDS | 25 | Not reported | 7.3 | 52.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.3
- upper Limit
- 52.4
- value
- 25
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- ORR for MDS cohort is defined as the percentage of participants achieving Complete Response (CR), Marrow CR, CRp (as per CR but platelet count \<100 x 10\^9 cells/Liter\[L\]), CRi (as per CR but platelet count \<100 x 10\^9cells/L or neutrophil count \<1 x 10\^9 cells/L), or Partial Response (PR) per response criteria. Complete response is defined as bone marrow \<=5% myeloblasts with normal maturation of all cell lines, with hemoglobin concentration of \>=11 grams per deciliter (g/dL), absolute neutrophil count \>=1 x 10\^9 cells/L, platelet count \>=100x10\^9 cells/L and 0% blasts in the peripheral blood. Marrow CR is defined as Bone marrow \<=5% myeloblasts and decrease by \>=50% over pre-treatment. Objective response rate was determined by the investigator according to international myeloma working group (IMWG) response criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
- id
- OG000
- title
- Part 2: GSK525762 75 mg QD MDS
- param Type
- NUMBER
- population Description
- All Treated Population
- reporting Status
- POSTED
- time Frame
- Up to 36.4 weeks
- title
- Part 2: Objective Response Rate (ORR) (MDS Cohort)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice