TriangleNCT00651261 · OUTCOME
Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant
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
- Duration of study (Up to 10 years)
What was measured
Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Groups in this outcome
Induction and Consolidation Chemotherapy Plus Midostaurin
Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
Induction and Consolidation Chemotherapy Plus Placebo
Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
| Group | Source count |
|---|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | 360 |
| Induction and Consolidation Chemotherapy Plus Placebo | 357 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | NA | Not reported | NA | NA | The median overall survival with censoring for transplant has not been reached |
| Induction and Consolidation Chemotherapy Plus Placebo | NA | Not reported | 27.4 | NA | The median overall survival with censoring for transplant has not been reached |
Complete source fields
- classes
- categories
- measurements
- comment
- The median overall survival with censoring for transplant has not been reached
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median overall survival with censoring for transplant has not been reached
- group Id
- OG001
- lower Limit
- 27.4
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 360
- group Id
- OG001
- value
- 357
- units
- Participants
- description
- Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
- id
- OG000
- title
- Induction and Consolidation Chemotherapy Plus Midostaurin
- description
- Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
- id
- OG001
- title
- Induction and Consolidation Chemotherapy Plus Placebo
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Duration of study (Up to 10 years)
- title
- Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice