TriangleNCT02314247 · OUTCOME
Duration of Stable Disease, Including Patients With Partial Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment.
What was measured
Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.
Analysis population: Those participants with stable disease, including those with partial response, as a subset of the Intent to Treat (ITT) population
Groups in this outcome
Selinexor (PTCL)
Assigned to 60 mg, 6 doses/cycle
Selinexor (CTCL)
Assigned to 60 mg, 6 doses/cycle
| Group | Source count |
|---|---|
| Selinexor (PTCL) | 3 |
| Selinexor (CTCL) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selinexor (PTCL) | 120.5 | Not reported | 111.0 | 130.0 | Not reported |
| Selinexor (CTCL) | 112.0 | Not reported | 85.0 | 225.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 111.0
- upper Limit
- 130.0
- value
- 120.5
- group Id
- OG001
- lower Limit
- 85.0
- upper Limit
- 225.0
- value
- 112.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Assigned to 60 mg, 6 doses/cycle
- id
- OG000
- title
- Selinexor (PTCL)
- description
- Assigned to 60 mg, 6 doses/cycle
- id
- OG001
- title
- Selinexor (CTCL)
- param Type
- MEDIAN
- population Description
- Those participants with stable disease, including those with partial response, as a subset of the Intent to Treat (ITT) population
- reporting Status
- POSTED
- time Frame
- Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment.
- title
- Duration of Stable Disease, Including Patients With Partial Response
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice