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NCT03301857 · OUTCOME

Number of Participants Receiving GCTB Interventions

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

GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.

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.

Not Exposed to IP

Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.

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
Not Exposed to IP34

Reported measurements

Surgery for GCTB
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP1Not reportedNot reportedNot reportedNot reported
Not Exposed to IP3Not reportedNot reportedNot reportedNot reported
Chemotherapy or Other Therapeutic Agents
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP0Not reportedNot reportedNot reportedNot reported
Not Exposed to IP2Not reportedNot reportedNot reportedNot reported
Embolization
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP0Not reportedNot reportedNot reportedNot reported
Not Exposed to IP0Not reportedNot reportedNot reportedNot reported
Interferon
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP0Not reportedNot reportedNot reportedNot reported
Not Exposed to IP0Not reportedNot reportedNot reportedNot reported
Radiotherapy
Values in Count of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exposed to IP0Not reportedNot reportedNot reportedNot reported
Not Exposed to IP0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Surgery for GCTB
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Chemotherapy or Other Therapeutic Agents
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Embolization
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Interferon
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Radiotherapy
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    2. group Id
      OG001
      value
      34
    units
    Participants
description
GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
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
  2. description
    Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
    id
    OG001
    title
    Not 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 Receiving GCTB Interventions
type
SECONDARY
unit Of Measure
Count of Participants

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

Preserved source evidence · Not medical advice