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NCT03301857 · OUTCOME

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 · Source last updated 2024-05-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Count of Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 5 years

What was measured

An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \[severe or medically significant but not immediately life-threatening\], 4 \[life-threatening\], and 5 \[death related to the AE\]) using the Common Terminology Criteria for Adverse Events (CTCAE).

Analysis population: FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.

Groups in this outcome

Exposed to IP

Participants who received denosumab at the conclusion of Study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.

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

Analysis denominator · Participants

GroupSource count
Exposed to IP51

Reported measurements

All TEAEs
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP47Not reportedNot reportedNot reportedNot reported
Serious TEAEs
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP8Not reportedNot reportedNot reportedNot reported
Fatal TEAEs
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP0Not reportedNot reportedNot reportedNot reported
TEAEs leading to IP discontinuation
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP9Not reportedNot reportedNot reportedNot reported
CTCAE Grade 3, 4, or 5
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP16Not reportedNot reportedNot reportedNot reported
All TEAEs related to IP
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47
    title
    All TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Serious TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Fatal TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    TEAEs leading to IP discontinuation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    CTCAE Grade 3, 4, or 5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    All TEAEs related to IP
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \[severe or medically significant but not immediately life-threatening\], 4 \[life-threatening\], and 5 \[death related to the AE\]) using the Common Terminology Criteria for Adverse Events (CTCAE).
groups
  1. description
    Participants who received denosumab at the conclusion of Study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
    id
    OG000
    title
    Exposed to IP
param Type
NUMBER
population Description
FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
reporting Status
POSTED
time Frame
Up to approximately 5 years
title
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
type
SECONDARY
unit Of Measure
Count of Participants

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

Preserved source evidence · Not medical advice