TriangleNCT04971226 · OUTCOME
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- At 48 weeks
What was measured
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Analysis population: The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization.
Groups in this outcome
Asciminib (All Asciminib )
Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
Investigator Selected TKI (All Comparators)
Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
| Group | Source count |
|---|---|
| Asciminib (All Asciminib ) | 201 |
| Investigator Selected TKI (All Comparators) | 204 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Asciminib (All Asciminib ) | 136 | Not reported | Not reported | Not reported | Not reported |
| Investigator Selected TKI (All Comparators) | 100 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 9.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 28.17
- estimate Comment
- The Estimate Value is a percentage.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- The Confidence Interval are percentages.
- p Value
- <0.001
- param Type
- Risk Difference (RD)
- param Value
- 18.88
- statistical Method
- Mantel Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 9.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 28.17
- estimate Comment
- The Estimate Value is a percentage.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- The Confidence Interval are percentages.
- p Value
- <0.001
- param Type
- Risk Difference (RD)
- param Value
- 18.88
- statistical Method
- Mantel Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 204
- units
- Participants
- description
- Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- groups
- description
- Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
- id
- OG000
- title
- Asciminib (All Asciminib )
- description
- Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
- id
- OG001
- title
- Investigator Selected TKI (All Comparators)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization.
- reporting Status
- POSTED
- time Frame
- At 48 weeks
- title
- Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice