TriangleNCT04582539 · OUTCOME
The Largest Increase From Baseline in the Mean Hgb Values Over Any Rolling 8-week Treatment Period During the First 24 Weeks of Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- grams per liter
- Interval / dispersion
- Standard Deviation
- Time frame
- up to Week 24
What was measured
Baseline Hgb was measured up to 8 weeks prior to the first dose administration of zilurgisertib. The baseline Hgb was defined as the average of all eligible Hgb assessments. The Hgb assessment(s) within the window from the date received RBC transfusion+1 day to the date received RBC transfusion+14 days that didn't trigger another transfusion were excluded.
Analysis population: Full Analysis Set-MDS. Participants were included in the mean change from baseline in hemoglobin value analysis if the participant was in the FAS and met both of the following criteria: a. was on treatment for more than 8 weeks; b. had ≥1 valid post-baseline Hgb assessment(s).
Groups in this outcome
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
| Group | Source count |
|---|---|
| Zilurgisertib 50 mg QD | 3 |
| Zilurgisertib 100 mg QD | 4 |
| Zilurgisertib 200 mg QD | 3 |
| Zilurgisertib 400 mg QD | 5 |
| Zilurgisertib 600 mg QD | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zilurgisertib 50 mg QD | 2.19 | 2.782 | Not reported | Not reported | Not reported |
| Zilurgisertib 100 mg QD | 9.73 | 2.842 | Not reported | Not reported | Not reported |
| Zilurgisertib 200 mg QD | 2.51 | 3.681 | Not reported | Not reported | Not reported |
| Zilurgisertib 400 mg QD | 4.92 | 10.240 | Not reported | Not reported | Not reported |
| Zilurgisertib 600 mg QD | 6.59 | 4.229 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.782
- value
- 2.19
- group Id
- OG001
- spread
- 2.842
- value
- 9.73
- group Id
- OG002
- spread
- 3.681
- value
- 2.51
- group Id
- OG003
- spread
- 10.240
- value
- 4.92
- group Id
- OG004
- spread
- 4.229
- value
- 6.59
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- units
- Participants
- description
- Baseline Hgb was measured up to 8 weeks prior to the first dose administration of zilurgisertib. The baseline Hgb was defined as the average of all eligible Hgb assessments. The Hgb assessment(s) within the window from the date received RBC transfusion+1 day to the date received RBC transfusion+14 days that didn't trigger another transfusion were excluded.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
- id
- OG000
- title
- Zilurgisertib 50 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
- id
- OG001
- title
- Zilurgisertib 100 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
- id
- OG002
- title
- Zilurgisertib 200 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
- id
- OG003
- title
- Zilurgisertib 400 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
- id
- OG004
- title
- Zilurgisertib 600 mg QD
- param Type
- MEAN
- population Description
- Full Analysis Set-MDS. Participants were included in the mean change from baseline in hemoglobin value analysis if the participant was in the FAS and met both of the following criteria: a. was on treatment for more than 8 weeks; b. had ≥1 valid post-baseline Hgb assessment(s).
- reporting Status
- POSTED
- time Frame
- up to Week 24
- title
- The Largest Increase From Baseline in the Mean Hgb Values Over Any Rolling 8-week Treatment Period During the First 24 Weeks of Treatment
- type
- SECONDARY
- unit Of Measure
- grams per liter
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Preserved source evidence · Not medical advice