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NCT02928029 · OUTCOME

Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma · Source last updated 2020-02-26

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 the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years

What was measured

A treatment-emergent adverse event (TEAE) is defined as any event arising or worsening after start of study drug administration until the end of the treatment period

Analysis population: The safety analysis set including all participants who received at least one administration of study treatment

Groups in this outcome

Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone

Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX

Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone

Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX

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

Analysis denominator · Participants

GroupSource count
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone3
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone4

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone3Not reportedNot reportedNot reportedNot reported
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Any drug-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone3Not reportedNot reportedNot reportedNot reported
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Any treatment-emergent serious AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
    title
    Any drug-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Any treatment-emergent serious AE
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    units
    Participants
description
A treatment-emergent adverse event (TEAE) is defined as any event arising or worsening after start of study drug administration until the end of the treatment period
groups
  1. description
    Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
    id
    OG000
    title
    Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
  2. description
    Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
    id
    OG001
    title
    Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set including all participants who received at least one administration of study treatment
reporting Status
POSTED
time Frame
From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years
title
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice