NCT02663518 · OUTCOME
Part 2: Overall Response Rate (ORR)-Savona 2015- 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 complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).
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: Myelodysplastic Syndrome (MDS)
Participants with MDS who received study drug in part 2.
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in part 2.
| Group | Source count |
|---|---|
| Part 2: Myelodysplastic Syndrome (MDS) | 6 |
| Part 2: Myeloproliferative Neoplasms (MPN) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Myelodysplastic Syndrome (MDS) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Myeloproliferative Neoplasms (MPN) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).
- groups
- description
- Participants with MDS who received study drug in part 2.
- id
- OG000
- title
- Part 2: Myelodysplastic Syndrome (MDS)
- description
- Participants with MPN who received study drug in part 2.
- id
- OG001
- title
- Part 2: Myeloproliferative Neoplasms (MPN)
- 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)-Savona 2015- Disease Indication
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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