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NCT04730349 · OUTCOME

Number of Participants With Serious Adverse Events (SAEs) - Part A

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer · Source last updated 2023-03-24

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 to 30 days after last dose (up to approximately 6 months)

What was measured

Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Analysis population: All treated participants in Part A

Groups in this outcome

Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)

Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks

Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)

Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks

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

Analysis denominator · Participants

GroupSource count
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)8
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)6Not reportedNot reportedNot reportedNot reported
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
groups
  1. description
    Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
    id
    OG000
    title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
  2. description
    Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
    id
    OG001
    title
    Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants in Part A
reporting Status
POSTED
time Frame
From first dose to 30 days after last dose (up to approximately 6 months)
title
Number of Participants With Serious Adverse Events (SAEs) - Part A
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice