NCT02663518 · OUTCOME
Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-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 response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).
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
Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3.
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Olsen 2011 in Parts 2 and 3.
| Group | Source count |
|---|---|
| Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL) | 21 |
| Parts 2 and 3: T-cell Lymphoma (TCL) | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL) | 2 | Not reported | Not reported | Not reported | Not reported |
| Parts 2 and 3: T-cell Lymphoma (TCL) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 29
- units
- Participants
- description
- ORR is presented in this outcome measure as number of responders. Responders were those who had complete response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).
- groups
- description
- Participants with CTCL who received study drug in Parts 2 and 3.
- id
- OG000
- title
- Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL)
- description
- Participants with TCL who received study drug and response assessment by Olsen 2011 in Parts 2 and 3.
- id
- OG001
- title
- Parts 2 and 3: T-cell Lymphoma (TCL)
- 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
- Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-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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