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NCT03441360 · OUTCOME

Number of Participants With Shift From Baseline to Worst Post-baseline for Lansky Play-performance Scale

Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS) · Source last updated 2022-10-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to approximately 32 months

What was measured

Reduced activities of daily living was assessed using the Lansky Play Performance Scale, where 100=fully active; 90=minor restrictions in strenuous physical activity; 80=active, gets tired more quickly; 70=greater restriction of play, less time spent in play activity; 60=up and around, active play minimal; quieter activities; 50=lying around much of the day; no active playing, all quiet play and activities; 40=mainly in bed; quiet activities; 30=bedbound; needs assistance even for quiet play; 20=sleeps often; play limited to very passive activities; 10=doesn't play or get out of bed; 5=unresponsive 0=dead. Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.

Analysis population: The safety analysis set included all participants who receive at least 1 dose of study drug. Here overall number analyzed "N" are the participants who were evaluable for the outcome measure with non-missing data at both baseline and any post-baseline timepoint.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Eribulin Mesylate 1.4 mg/m^2: RMS7
Eribulin Mesylate 1.4 mg/m^2: NRSTS7
Eribulin Mesylate 1.4 mg/m^2: EWS4

Reported measurements

Baseline score 70 to worst post-baseline score 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS2Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS1Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 70 to worst post-baseline score 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 80 to worst post-baseline score 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 80 to worst post-baseline score 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 80 to worst post-baseline score 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 80 to worst post-baseline score 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS2Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS1Not reportedNot reportedNot reportedNot reported
Baseline score 80 to worst post-baseline score 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 80 to worst post-baseline score 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS1Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS1Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS2Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 90 to worst post-baseline score 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 100 to worst post-baseline score 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 100 to worst post-baseline score 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 100 to worst post-baseline score 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 100 to worst post-baseline score 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 100 to worst post-baseline score 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Baseline score 100 to worst post-baseline score 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS0Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS1Not reportedNot reportedNot reportedNot reported
Eribulin Mesylate 1.4 mg/m^2: EWS0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 50
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 60
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Baseline score 70 to worst post-baseline score 70
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 80
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 90
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 70 to worst post-baseline score 100
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 80 to worst post-baseline score 50
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 80 to worst post-baseline score 60
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Baseline score 80 to worst post-baseline score 70
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Baseline score 80 to worst post-baseline score 80
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 80 to worst post-baseline score 90
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 80 to worst post-baseline score 100
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Reduced activities of daily living was assessed using the Lansky Play Performance Scale, where 100=fully active; 90=minor restrictions in strenuous physical activity; 80=active, gets tired more quickly; 70=greater restriction of play, less time spent in play activity; 60=up and around, active play minimal; quieter activities; 50=lying around much of the day; no active playing, all quiet play and activities; 40=mainly in bed; quiet activities; 30=bedbound; needs assistance even for quiet play; 20=sleeps often; play limited to very passive activities; 10=doesn't play or get out of bed; 5=unresponsive 0=dead. Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
groups
  1. 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
  2. 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
  3. 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
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all participants who receive at least 1 dose of study drug. Here overall number analyzed "N" are the participants who were evaluable for the outcome measure with non-missing data at both baseline and any post-baseline timepoint.
reporting Status
POSTED
time Frame
Baseline up to approximately 32 months
title
Number of Participants With Shift From Baseline to Worst Post-baseline for Lansky Play-performance Scale
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice