TriangleNCT01102426 · OUTCOME
Percentage of Participants With Progression-free Survival (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 date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
What was measured
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. 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 If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
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 | 171 |
| Dexamethasone | 84 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Plitidepsin+Dexamethasone | 26.4 | Not reported | 19.1 | 33.7 | Not reported |
| Dexamethasone | 8.1 | Not reported | 1.9 | 14.3 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- statistical Method
- Normal approximation
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- statistical Method
- Normal approximation
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.1
- upper Limit
- 33.7
- value
- 26.4
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 14.3
- value
- 8.1
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. 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 If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
- 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
- reporting Status
- POSTED
- time Frame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
- title
- Percentage of Participants With Progression-free Survival (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