TriangleNCT03441360 · OUTCOME
Number of Participants With Any Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
What was measured
An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or (1) reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
Analysis population: The safety analysis set 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
TEAEs
| 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 | 8 | 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 |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eribulin Mesylate 1.4 mg/m^2: RMS | 6 | 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 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 5
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or (1) reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
- 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.
- reporting Status
- POSTED
- time Frame
- From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
- title
- Number of Participants With Any Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice