TriangleNCT02663518 · OUTCOME
Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication
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 first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
What was measured
ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).
Analysis population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 2: Acute Myeloid Leukemia (AML)
Participants with AML who received study drug in part 2.
| Group | Source count |
|---|---|
| Part 2: Acute Myeloid Leukemia (AML) | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Acute Myeloid Leukemia (AML) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).
- groups
- description
- Participants with AML who received study drug in part 2.
- id
- OG000
- title
- Part 2: Acute Myeloid Leukemia (AML)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
- title
- Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice