Number of Participants With a Shift From Baseline to Worst Post-Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade in Laboratory Value
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
From first dose of study drug up to approximately 32 months
What was measured
Laboratory results were graded using CTCAE Version 4.03. As per CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences. 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 number analyzed "n" are the participants who were evaluable for the outcome measure for given categories with non-missing data at both baseline and any post-baseline.
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
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
Baseline to Worst Post-baseline Grade 0, Hemoglobin Decreased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, Hemoglobin Decreased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
3
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
4
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
3
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, Hemoglobin Decreased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
2
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, Hemoglobin Decreased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
5
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
3
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, Hemoglobin Decreased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, Hemoglobin increased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, Hemoglobin increased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Worst Post-Baseline Grade 2, Hemoglobin increased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, Hemoglobin increased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, Hemoglobin increased
Analysis denominator · Participants
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
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, White blood cells decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, White blood cells decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
4
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
1
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, White blood cells decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, White blood cells decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
3
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, White blood cells decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
1
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, White blood cells increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, White blood cells increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, White blood cells increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, White blood cells increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, White blood cells increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, Lymphocyte count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
3
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, Lymphocyte count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, Lymphocyte count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
3
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, Lymphocyte count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
4
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
2
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, Lymphocyte count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, Lymphocyte count increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
4
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, Lymphocyte count increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, Lymphocyte count increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, Lymphocyte count increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, Lymphocyte count increased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, Neutrophil count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
7
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
1
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, Neutrophil count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
7
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, Neutrophil count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
7
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
3
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, Neutrophil count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
7
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
3
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, Neutrophil count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
7
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
5
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
1
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 0, Platelet count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
5
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
6
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
3
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 1, Platelet count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
2
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
2
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 2, Platelet count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
1
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 3, Platelet count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Baseline to Worst Post-baseline Grade 4, Platelet count decreased
Analysis denominator · Participants
Group
Source count
Eribulin Mesylate 1.4 mg/m^2: RMS
8
Eribulin Mesylate 1.4 mg/m^2: NRSTS
7
Eribulin Mesylate 1.4 mg/m^2: EWS
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Eribulin Mesylate 1.4 mg/m^2: RMS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS
0
Not reported
Not reported
Not reported
Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 0, Hemoglobin Decreased
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 1, Hemoglobin Decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 2, Hemoglobin Decreased
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
3
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 3, Hemoglobin Decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 4, Hemoglobin Decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 0, Hemoglobin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 1, Hemoglobin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Worst Post-Baseline Grade 2, Hemoglobin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 3, Hemoglobin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 4, Hemoglobin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
7
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 0, White blood cells decreased
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
7
group Id
OG002
value
5
units
Participants
title
Baseline to Worst Post-baseline Grade 1, White blood cells decreased
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
5
units
Participants
description
Laboratory results were graded using CTCAE Version 4.03. As per CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences. 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
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
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all participants who receive at least 1 dose of study drug. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given categories with non-missing data at both baseline and any post-baseline.
reporting Status
POSTED
time Frame
From first dose of study drug up to approximately 32 months
title
Number of Participants With a Shift From Baseline to Worst Post-Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade in Laboratory Value
Triangle