TriangleNCT04173494 · OUTCOME
Percentage of Participants With a Hemoglobin Response
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
- Baseline and Week 24
What was measured
Hemoglobin responses are defined as increases of \>= 1, \>= 1.5, or \>= 2 g/dL from Baseline in Hgb, as measured over a (rolling) period of at least 12 consecutive weeks falling entirely before the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. Data has been reported for percentage of participants who had \>= 1, \>= 1.5, or \>= 2 g/dL increase from Baseline in hemoglobin.
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
>=1g/dL Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MMB 200 mg QD + Placebo | 53.08 | Not reported | 44.13 | 61.88 | Not reported |
| DAN 300 mg BID + Placebo | 33.85 | Not reported | 22.57 | 46.65 | Not reported |
>=1.5g/dL Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MMB 200 mg QD + Placebo | 40.00 | Not reported | 31.51 | 48.95 | Not reported |
| DAN 300 mg BID + Placebo | 23.08 | Not reported | 13.53 | 35.19 | Not reported |
>=2g/dL Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MMB 200 mg QD + Placebo | 29.23 | Not reported | 21.59 | 37.85 | Not reported |
| DAN 300 mg BID + Placebo | 20.00 | Not reported | 11.10 | 31.77 | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.32
- estimate Comment
- \>=1g/dL Increase in Hemoglobin response
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0124
- param Type
- Stratified CMH
- param Value
- 19.00
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 2.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 28.90
- estimate Comment
- \>=1.5g/dL Increase in Hemoglobin response
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0282
- param Type
- Stratified CMH
- param Value
- 15.68
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -5.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.35
- estimate Comment
- \>=2g/dL Increase in Hemoglobin response
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.2844
- param Type
- Stratified CMH
- param Value
- 6.97
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 4.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.32
- estimate Comment
- \>=1g/dL Increase in Hemoglobin response
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0124
- param Type
- Stratified CMH
- param Value
- 19.00
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 2.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 28.90
- estimate Comment
- \>=1.5g/dL Increase in Hemoglobin response
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0282
- param Type
- Stratified CMH
- param Value
- 15.68
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -5.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.35
- estimate Comment
- \>=2g/dL Increase in Hemoglobin response
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.2844
- param Type
- Stratified CMH
- param Value
- 6.97
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.13
- upper Limit
- 61.88
- value
- 53.08
- group Id
- OG001
- lower Limit
- 22.57
- upper Limit
- 46.65
- value
- 33.85
- title
- >=1g/dL Increase
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.51
- upper Limit
- 48.95
- value
- 40.00
- group Id
- OG001
- lower Limit
- 13.53
- upper Limit
- 35.19
- value
- 23.08
- title
- >=1.5g/dL Increase
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.59
- upper Limit
- 37.85
- value
- 29.23
- group Id
- OG001
- lower Limit
- 11.10
- upper Limit
- 31.77
- value
- 20.00
- title
- >=2g/dL Increase
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- Hemoglobin responses are defined as increases of \>= 1, \>= 1.5, or \>= 2 g/dL from Baseline in Hgb, as measured over a (rolling) period of at least 12 consecutive weeks falling entirely before the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. Data has been reported for percentage of participants who had \>= 1, \>= 1.5, or \>= 2 g/dL increase from Baseline in hemoglobin.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- ITT Analysis Set
- reporting Status
- POSTED
- time Frame
- Baseline and Week 24
- title
- Percentage of Participants With a Hemoglobin Response
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice