TriangleNCT02668653 · OUTCOME
Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
What was measured
Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure \[TF\]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: \>1000 neutrophils, \>100,000 platelets, \<5% blasts, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation.
Analysis population: Event-free survival was assessed in the Intent-to-Treat Analysis Set.
Groups in this outcome
Quizartinib
Participants who were randomized to receive quizartinib treatment regimen.
Placebo
Participants who were randomized to receive placebo treatment regimen.
| Group | Source count |
|---|---|
| Quizartinib | 268 |
| Placebo | 271 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Quizartinib | 0.03 | Not reported | 0.03 | 0.95 | Not reported |
| Placebo | 0.71 | Not reported | 0.03 | 3.42 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 0.95
- value
- 0.03
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 3.42
- value
- 0.71
- denoms
- counts
- group Id
- OG000
- value
- 268
- group Id
- OG001
- value
- 271
- units
- Participants
- description
- Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure \[TF\]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: \>1000 neutrophils, \>100,000 platelets, \<5% blasts, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who were randomized to receive quizartinib treatment regimen.
- id
- OG000
- title
- Quizartinib
- description
- Participants who were randomized to receive placebo treatment regimen.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Event-free survival was assessed in the Intent-to-Treat Analysis Set.
- reporting Status
- POSTED
- time Frame
- Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
- title
- Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice