TriangleNCT03441360 · OUTCOME
Percentage of Participants With Objective Response
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 up to first documentation of disease progression (PD) or date of death, whichever occurred first (approximately 32 months)
What was measured
Percentage of participants achieving a best objective response of partial response (PR) or complete response (CR) per RECIST 1.1, by up to 24 weeks after all participants have completed response assessment. Response assessment was determined by investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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 | 0 | Not reported | 0.0 | 36.9 | Not reported |
| Eribulin Mesylate 1.4 mg/m^2: NRSTS | 0 | Not reported | 0.0 | 36.9 | Not reported |
| Eribulin Mesylate 1.4 mg/m^2: EWS | 0 | Not reported | 0.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- Percentage of participants achieving a best objective response of partial response (PR) or complete response (CR) per RECIST 1.1, by up to 24 weeks after all participants have completed response assessment. Response assessment was determined by investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- 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
- NUMBER
- population Description
- The FAS included all participants who receive at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From date of randomization up to first documentation of disease progression (PD) or date of death, whichever occurred first (approximately 32 months)
- title
- Percentage of Participants With Objective Response
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice