TriangleNCT01102426 · OUTCOME
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
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
- 95% Confidence Interval
- Time frame
- From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
What was measured
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Analysis population: Patients with documentation of response
Groups in this outcome
Plitidepsin+Dexamethasone
plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
Dexamethasone
dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
| Group | Source count |
|---|---|
| Plitidepsin+Dexamethasone | 51 |
| Dexamethasone | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 38.2 | Not reported | 23.7 | 52.8 | Not reported |
| Dexamethasone | 0.0 | Not reported | 0.0 | NA | not reached |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.7
- upper Limit
- 52.8
- value
- 38.2
- comment
- not reached
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- NA
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- dispersion Type
- 95% Confidence Interval
- groups
- description
- plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
- id
- OG000
- title
- Plitidepsin+Dexamethasone
- description
- dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
- id
- OG001
- title
- Dexamethasone
- param Type
- NUMBER
- population Description
- Patients with documentation of response
- reporting Status
- POSTED
- time Frame
- From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
- title
- Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice