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NCT03245151 · OUTCOME

Phase 2: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors · Source last updated 2023-08-30

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 first dose up to 28 days after the last dose of study treatment (up to 7.5 months)

What was measured

A TESAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.

Analysis population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

Groups in this outcome

Phase 2: Cohort 1, Ewing Sarcoma

Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.

Phase 2: Cohort 2, Rhabdomyosarcoma

Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.

Phase 2: Cohort 3, HGG

Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Cohort 1, Ewing Sarcoma10
Phase 2: Cohort 2, Rhabdomyosarcoma20
Phase 2: Cohort 3, HGG11

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Cohort 1, Ewing Sarcoma6Not reportedNot reportedNot reportedNot reported
Phase 2: Cohort 2, Rhabdomyosarcoma8Not reportedNot reportedNot reportedNot reported
Phase 2: Cohort 3, HGG8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      11
    units
    Participants
description
A TESAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.
groups
  1. description
    Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
    id
    OG000
    title
    Phase 2: Cohort 1, Ewing Sarcoma
  2. description
    Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
    id
    OG001
    title
    Phase 2: Cohort 2, Rhabdomyosarcoma
  3. description
    Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
    id
    OG002
    title
    Phase 2: Cohort 3, HGG
param Type
COUNT_OF_PARTICIPANTS
population Description
SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).
reporting Status
POSTED
time Frame
From date of first dose up to 28 days after the last dose of study treatment (up to 7.5 months)
title
Phase 2: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice