TriangleNCT01371981 · OUTCOME
EFS for Patients on Arm C, Cohort 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years
What was measured
The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death.
Analysis population: Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients.
Groups in this outcome
Arm C (Cohort 2)
IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I \& concurrently with chemo). IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36. INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28. INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2. Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year.
| Group | Source count |
|---|---|
| Arm C (Cohort 2) | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm C (Cohort 2) | 56.12 | Not reported | 37.33 | 71.28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 37.33
- upper Limit
- 71.28
- value
- 56.12
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- description
- The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I \& concurrently with chemo). IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36. INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28. INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2. Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year.
- id
- OG000
- title
- Arm C (Cohort 2)
- param Type
- NUMBER
- population Description
- Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- EFS for Patients on Arm C, Cohort 2
- type
- PRIMARY
- unit Of Measure
- percentage of patients
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Preserved source evidence · Not medical advice