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NCT00680992 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Study of Denosumab in Subjects With Giant Cell Tumor of Bone · Source last updated 2022-09-22

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).

What was measured

AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. Investigator assessed AEs for relatedness to study drug. Results are presented for treatment-emergent events (TEAEs) and included all AEs occurring from first dose in initial treatment phase to end of initial treatment phase (or for participants entering retreatment, from first dose in initial treatment phase until end of retreatment phase).

Analysis population: The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.

Groups in this outcome

Cohort 1 (Denosumab 120 mg Q4W)

Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.

Cohort 2 (Denosumab 120 mg Q4W)

Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.

Cohort 3 (Denosumab 120 mg Q4W)

Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.

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

Analysis denominator · Participants

GroupSource count
Cohort 1 (Denosumab 120 mg Q4W)265
Cohort 2 (Denosumab 120 mg Q4W)249
Cohort 3 (Denosumab 120 mg Q4W)12

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)260Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)231Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)12Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)98Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)39Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)5Not reportedNot reportedNot reportedNot reported
Fatal TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)8Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)3Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)0Not reportedNot reportedNot reportedNot reported
TEAE leading to treatment phase discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)27Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)24Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)1Not reportedNot reportedNot reportedNot reported
TEAE leading to study drug discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)27Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)23Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)1Not reportedNot reportedNot reportedNot reported
CTCAE Grade 3, 4, or 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)121Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)59Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)6Not reportedNot reportedNot reportedNot reported
Any TEAE related to study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Denosumab 120 mg Q4W)184Not reportedNot reportedNot reportedNot reported
Cohort 2 (Denosumab 120 mg Q4W)136Not reportedNot reportedNot reportedNot reported
Cohort 3 (Denosumab 120 mg Q4W)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        260
      2. group Id
        OG001
        value
        231
      3. group Id
        OG002
        value
        12
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        5
    title
    Serious TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
    title
    Fatal TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        1
    title
    TEAE leading to treatment phase discontinuation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        1
    title
    TEAE leading to study drug discontinuation
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        59
      3. group Id
        OG002
        value
        6
    title
    CTCAE Grade 3, 4, or 5
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        184
      2. group Id
        OG001
        value
        136
      3. group Id
        OG002
        value
        9
    title
    Any TEAE related to study drug
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      249
    3. group Id
      OG002
      value
      12
    units
    Participants
description
AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. Investigator assessed AEs for relatedness to study drug. Results are presented for treatment-emergent events (TEAEs) and included all AEs occurring from first dose in initial treatment phase to end of initial treatment phase (or for participants entering retreatment, from first dose in initial treatment phase until end of retreatment phase).
groups
  1. description
    Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
    id
    OG000
    title
    Cohort 1 (Denosumab 120 mg Q4W)
  2. description
    Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
    id
    OG001
    title
    Cohort 2 (Denosumab 120 mg Q4W)
  3. description
    Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
    id
    OG002
    title
    Cohort 3 (Denosumab 120 mg Q4W)
param Type
NUMBER
population Description
The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.
reporting Status
POSTED
time Frame
From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).
title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice