TriangleNCT03441360 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the time from the first dose date to the date of disease progression (PD) or date of death, whichever occurred first (up to approximately 32 months)
What was measured
PFS was defined as the time from the first dose date to the date of PD or date of death (whichever occurred first). PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). Data for this secondary endpoint was collected and analyzed up to the primary completion date (PCD). As there was no further data collected, therefore data is reported till PCD only.
Analysis population: The FAS included all participants who receive at least 1 dose of study drug.
Groups in this outcome
Eribulin Mesylate 1.4 mg/m^2: RMS
Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
Eribulin Mesylate 1.4 mg/m^2: NRSTS
Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
Eribulin Mesylate 1.4 mg/m^2: EWS
Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
| Group | Source count |
|---|---|
| Eribulin Mesylate 1.4 mg/m^2: RMS | 8 |
| Eribulin Mesylate 1.4 mg/m^2: NRSTS | 8 |
| Eribulin Mesylate 1.4 mg/m^2: EWS | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eribulin Mesylate 1.4 mg/m^2: RMS | 1.74 | Not reported | 1.12 | 2.86 | Not reported |
| Eribulin Mesylate 1.4 mg/m^2: NRSTS | 1.30 | Not reported | 0.62 | 1.51 | Not reported |
| Eribulin Mesylate 1.4 mg/m^2: EWS | 0.76 | Not reported | 0.59 | 4.04 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.12
- upper Limit
- 2.86
- value
- 1.74
- group Id
- OG001
- lower Limit
- 0.62
- upper Limit
- 1.51
- value
- 1.30
- group Id
- OG002
- lower Limit
- 0.59
- upper Limit
- 4.04
- value
- 0.76
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- PFS was defined as the time from the first dose date to the date of PD or date of death (whichever occurred first). PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). Data for this secondary endpoint was collected and analyzed up to the primary completion date (PCD). As there was no further data collected, therefore data is reported till PCD only.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- id
- OG000
- title
- Eribulin Mesylate 1.4 mg/m^2: RMS
- description
- Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- id
- OG001
- title
- Eribulin Mesylate 1.4 mg/m^2: NRSTS
- description
- Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- id
- OG002
- title
- Eribulin Mesylate 1.4 mg/m^2: EWS
- param Type
- MEDIAN
- population Description
- The FAS included all participants who receive at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From the time from the first dose date to the date of disease progression (PD) or date of death, whichever occurred first (up to approximately 32 months)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice