TriangleNCT03306264 · OUTCOME
AML: Number of Participants With Grade 3 or Higher TEAEs
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
- From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years)
What was measured
TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using CTCAE version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.
Analysis population: The Safety Analysis Set included all participants who received any amount of study treatment.
Groups in this outcome
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 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, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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 |
|---|---|
| AML: IV Decitabine | 78 |
| AML: ASTX727 | 80 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: IV Decitabine | 43 | Not reported | Not reported | Not reported | Not reported |
| AML: ASTX727 | 73 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 73
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 80
- units
- Participants
- description
- TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using CTCAE version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.
- groups
- description
- Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days).
- id
- OG000
- title
- AML: IV Decitabine
- description
- Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 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
- AML: ASTX727
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Analysis Set included all participants who received any amount of study treatment.
- reporting Status
- POSTED
- time Frame
- From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years)
- title
- AML: Number of Participants With Grade 3 or Higher TEAEs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice