TriangleNCT04173494 · OUTCOME
Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Whole blood units
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to Week 24
What was measured
Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study.
Analysis population: ITT Analysis Set.
Groups in this outcome
MMB 200 mg QD + Placebo
Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.
DAN 300 mg BID + Placebo
Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
| Group | Source count |
|---|---|
| MMB 200 mg QD + Placebo | 130 |
| DAN 300 mg BID + Placebo | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MMB 200 mg QD + Placebo | 6.55 | 8.413 | Not reported | Not reported | Not reported |
| DAN 300 mg BID + Placebo | 10.86 | 13.203 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.397
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.778
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0006
- param Type
- Hazard Ratio (HR)
- param Value
- 0.556
- statistical Method
- Anderson & Gill proportional means model
Complete source fields
- analyses
- ci Lower Limit
- 0.397
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.778
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0006
- param Type
- Hazard Ratio (HR)
- param Value
- 0.556
- statistical Method
- Anderson & Gill proportional means model
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.413
- value
- 6.55
- group Id
- OG001
- spread
- 13.203
- value
- 10.86
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.
- id
- OG000
- title
- MMB 200 mg QD + Placebo
- description
- Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
- id
- OG001
- title
- DAN 300 mg BID + Placebo
- param Type
- MEAN
- population Description
- ITT Analysis Set.
- reporting Status
- POSTED
- time Frame
- Up to Week 24
- title
- Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks
- type
- SECONDARY
- unit Of Measure
- Whole blood units
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice