TriangleNCT00866281 · OUTCOME
Time to Response With Midostaurin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)
What was measured
Time to response was defined as the time from the date of start of midostaurin treatment to the date of first response. The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Time to response was calculated by using the formula = (date of first response -date of start of midostaurin) +1 day.
Analysis population: The analysis was performed in FAS population. Here, "Number of participants analysed" signifies number of responders at specified time points for each arm, respectively.
Groups in this outcome
AML Subjects
Subjects with acute myeloid leukemia (AML) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.
MLLr-ALL Subjects
Subjects with mixed lineage leukemia gene- rearranged acute lymphoblastic leukemia (MLLr-ALL) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.
| Group | Source count |
|---|---|
| AML Subjects | 5 |
| MLLr-ALL Subjects | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML Subjects | 14.0 | Not reported | 8.0 | 22.0 | Not reported |
| MLLr-ALL Subjects | 8.0 | Not reported | 3.0 | 8.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.0
- upper Limit
- 22.0
- value
- 14.0
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 8.0
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Time to response was defined as the time from the date of start of midostaurin treatment to the date of first response. The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Time to response was calculated by using the formula = (date of first response -date of start of midostaurin) +1 day.
- dispersion Type
- Full Range
- groups
- description
- Subjects with acute myeloid leukemia (AML) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.
- id
- OG000
- title
- AML Subjects
- description
- Subjects with mixed lineage leukemia gene- rearranged acute lymphoblastic leukemia (MLLr-ALL) and received body-weight stratified dosage midostaurin 30 or 60 mg/m\^2.
- id
- OG001
- title
- MLLr-ALL Subjects
- param Type
- MEDIAN
- population Description
- The analysis was performed in FAS population. Here, "Number of participants analysed" signifies number of responders at specified time points for each arm, respectively.
- reporting Status
- POSTED
- time Frame
- Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)
- title
- Time to Response With Midostaurin
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice