TriangleNCT03306264 · OUTCOME
Maximum Percentage of Long Interspersed Nucleotide Elements (LINE)-1 Demethylation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- percentage of demethylation
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Pre-dose on Day 1 of Cycles 1 and 2 (as Baseline), and Days 8, 15 and 22 of Cycles 1 and 2 (each cycle= 28 days)
What was measured
Summarized data for Cycle 1 and Cycle 2 was reported.
Analysis population: Pharmacodynamic (PD) LINE-1 Analysis Set included participants who received any amount of study treatment and have LINE-1 methylation data at baseline (Day 1) of Cycle 1 or 2 and on either Day 8 or Day 15 of the respective cycle. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those participants who were evaluable for this outcome measure at specified time point.
Groups in this outcome
MDS or CMML: IV Decitabine
Participants with MDS or CMML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: IV Decitabine
Participants with AML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
| Group | Source count |
|---|---|
| MDS or CMML: IV Decitabine | 63 |
| MDS or CMML: ASTX727 | 63 |
| AML: IV Decitabine | 39 |
| AML: ASTX727 | 34 |
Reported measurements
Cycle 1
| Group | Source count |
|---|---|
| MDS or CMML: IV Decitabine | 62 |
| MDS or CMML: ASTX727 | 62 |
| AML: IV Decitabine | 39 |
| AML: ASTX727 | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS or CMML: IV Decitabine | 14.019 | Not reported | 12.528 | 15.510 | Not reported |
| MDS or CMML: ASTX727 | 13.289 | Not reported | 11.798 | 14.780 | Not reported |
| AML: IV Decitabine | 8.243 | Not reported | 6.340 | 10.147 | Not reported |
| AML: ASTX727 | 9.357 | Not reported | 7.288 | 11.426 | Not reported |
Cycle 2
| Group | Source count |
|---|---|
| MDS or CMML: IV Decitabine | 63 |
| MDS or CMML: ASTX727 | 63 |
| AML: IV Decitabine | 29 |
| AML: ASTX727 | 34 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS or CMML: IV Decitabine | 11.968 | Not reported | 10.503 | 13.434 | Not reported |
| MDS or CMML: ASTX727 | 11.151 | Not reported | 9.685 | 12.616 | Not reported |
| AML: IV Decitabine | 8.153 | Not reported | 6.226 | 10.079 | Not reported |
| AML: ASTX727 | 8.037 | Not reported | 6.258 | 9.816 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.528
- upper Limit
- 15.510
- value
- 14.019
- group Id
- OG001
- lower Limit
- 11.798
- upper Limit
- 14.780
- value
- 13.289
- group Id
- OG002
- lower Limit
- 6.340
- upper Limit
- 10.147
- value
- 8.243
- group Id
- OG003
- lower Limit
- 7.288
- upper Limit
- 11.426
- value
- 9.357
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 62
- group Id
- OG002
- value
- 39
- group Id
- OG003
- value
- 33
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.503
- upper Limit
- 13.434
- value
- 11.968
- group Id
- OG001
- lower Limit
- 9.685
- upper Limit
- 12.616
- value
- 11.151
- group Id
- OG002
- lower Limit
- 6.226
- upper Limit
- 10.079
- value
- 8.153
- group Id
- OG003
- lower Limit
- 6.258
- upper Limit
- 9.816
- value
- 8.037
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 63
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 34
- units
- Participants
- title
- Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 63
- group Id
- OG002
- value
- 39
- group Id
- OG003
- value
- 34
- units
- Participants
- description
- Summarized data for Cycle 1 and Cycle 2 was reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with MDS or CMML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).
- id
- OG000
- title
- MDS or CMML: IV Decitabine
- description
- Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
- id
- OG001
- title
- MDS or CMML: ASTX727
- description
- Participants with AML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).
- id
- OG002
- title
- AML: IV Decitabine
- description
- Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
- id
- OG003
- title
- AML: ASTX727
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Pharmacodynamic (PD) LINE-1 Analysis Set included participants who received any amount of study treatment and have LINE-1 methylation data at baseline (Day 1) of Cycle 1 or 2 and on either Day 8 or Day 15 of the respective cycle. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those participants who were evaluable for this outcome measure at specified time point.
- reporting Status
- POSTED
- time Frame
- Pre-dose on Day 1 of Cycles 1 and 2 (as Baseline), and Days 8, 15 and 22 of Cycles 1 and 2 (each cycle= 28 days)
- title
- Maximum Percentage of Long Interspersed Nucleotide Elements (LINE)-1 Demethylation
- type
- SECONDARY
- unit Of Measure
- percentage of demethylation
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice