TriangleNCT02653976 · OUTCOME
Tumor Response (Local Assessment)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months.
What was measured
Local assessments of tumor response were performed by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or PR (regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or SD as their best response.
Analysis population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).
Groups in this outcome
SP-02L (Darinaparsin for Injection)
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
| Group | Source count |
|---|---|
| SP-02L (Darinaparsin for Injection) | 57 |
Reported measurements
Overall Response Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SP-02L (Darinaparsin for Injection) | 26.3 | Not reported | 17.0 | 37.6 | Not reported |
Disease Control Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SP-02L (Darinaparsin for Injection) | 54.4 | Not reported | 42.7 | 65.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.0
- upper Limit
- 37.6
- value
- 26.3
- title
- Overall Response Rate
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.7
- upper Limit
- 65.7
- value
- 54.4
- title
- Disease Control Rate
- denoms
- counts
- group Id
- OG000
- value
- 57
- units
- Participants
- description
- Local assessments of tumor response were performed by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or PR (regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or SD as their best response.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
- id
- OG000
- title
- SP-02L (Darinaparsin for Injection)
- param Type
- NUMBER
- population Description
- Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).
- reporting Status
- POSTED
- time Frame
- Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months.
- title
- Tumor Response (Local Assessment)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice